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Volume 67, NUMBER 2

June 2009

Second annual United States comprehensive course on total hip re-surfacing arthroplasty 2008

Perceptions Concerning Hip Resurfacing from Attendees at The Second Annual U.S. Comprehensive Course on Total Hip Resurfacing Arthroplasty

Michael A. Mont, M.D., Thomas P. Schmalzried, M.D., Michael G. Zywiel, M.D., Mike S. McGrath, M.D., and Thorsten M. Seyler, M.D.

ABSTRACT
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Resurfacing hip arthroplasty represents a new, alternative technology to standard total hip arthroplasty. We examined the perceptions about resurfacing after the Second Annual United States Comprehensive Course on Total Hip Resurfacing Arthroplasty, which was a multi-company sponsored educational event to advance general knowledge, basic science, and surgical skills relevant to this feld. The course led to a substantial increase in knowledge concerning resurfacing as evaluated from pre- and post-tests. The perceptions concerning indications, patient selection, and beliefs of the course attendees are reported.

A Comparison of Total Hip Resurfacing and Total Hip Arthroplasty - Patients and Outcomes

Vincent A. Fowble, M.D., Mylene A. dela Rosa, B.S., C.C.R.P., and Thomas P. Schmalzried, M.D.

ABSTRACT
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A comparison of pertinent preoperative and postoperative data relative to total hip resurfacing versus total hip arthroplasty (THA) would assist in evaluating current perceptions in outcome. We compared 50 consecutive metal-metal resurfacing replacements in 50 patients with 44 consecutive conventional total hip arthroplasties in 35 patients, who were implanted during the same time period, by the same surgeon, and followed prospectively for 2 to 4 years. The patients undergoing hip resurfacing were 62% male, 9 years younger, and 3.2 inches taller, with a lower mean body mass index and American Society of Anesthesiologists (ASA) grade than patients undergoing total hip arthroplasty. Preoperatively, patients undergoing resurfacing had a lower Harris hip score (46 vs 52 points), more pain, higher UCLA (University of California at Los Angeles) activity scores (4.2 vs 3.6), and better range of motion. Surgical time for resurfacing was 18% longer, but there was less total blood loss and fewer transfusions. Postoperatively, there was no difference in Harris hip score (97 vs 96). Patients undergoing resurfacing had higher function, Short Form-12 physical activity scores, and UCLA activity scores, but also a higher incidence of slight or mild pain. There were no differences in postoperative range of motion or dislocation (one each). The preoperative characteristics and general health status of the average patient undergoing resurfacing are more favorable than that of the average patient undergoing conventional total hip arthroplasty. Caution should be applied in attributing differences in outcomes directly to the arthroplasty technology.

Minimally Invasive Hip Resurfacing Compared to Minimally Invasive Total Hip Arthroplasty

Michael L. Swank, M.D., and Martha R. Alkire, C.N.P.

ABSTRACT
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Background: Since its March 2006 FDA approval in the United States, Birmingham hip resurfacing (BHR) has been a popular alternative to hip arthroplasty for the younger patient population. Data to date has shown a trend toward low incidence of dislocation and good survivorship. Methods: 128 patients operated on by a single surgeon from July 2006 to December 2008 were reviewed for complications, pain, and function. A group of single incision, minimally invasive standard total hip replacements (106 cases) in 2008 was used for comparison of the same outcomes. Conclusion: Pain, function, and total Harris Hip scores were all improved by the 2 year mark and better than the total hip group. Overall incision lengths decreased over the study time period. The average age of the BHR recipient was 51 years, approximately 14 years less than the total hip mean age. Pain in the Birmingham group improved by 32 points at the 3 month mark. By the end of 2 years, the Birmingham group Harris Hip score mean was nearly perfect at 98.5 points. Rare incidence of complications, marked decreased pain scores and marked elevation in function were results found in this sample of Birmingham resurfacing.

Resurfacing Matched to Standard Total Hip Arthroplasty by Preoperative Activity Levels - A Comparison of Postoperative Outcomes

Michael G. Zywiel, M.D., David R. Marker, B.S., Mike S. McGrath, M.D., Ronald E. Delanois, M.D., and Michael A. Mont, M.D.

ABSTRACT
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Background: Some studies have suggested that resurfacing patients are generally more active postoperatively than their conventional total hip arthroplasty (THA)counterparts, but controversy remains over whether this is a refection of preferential use of resurfacing for younger and higher-activity patients. We hypothesized that, when controlling for preoperative activity levels, in addition to relevant clinical and demographic factors, resurfacing provides similar results to conventional hip arthroplasty. Materials and Methods: The specifc question asked was whether resurfacing patients had differences in postoperative activity level, clinical outcomes, or rate of revisions, as compared to a matched cohort of patients treated with conventional THA. Thirty-three patients (23 men and 10 women) who were treated with resurfacing arthroplasties were matched to a cohort of patients who underwent conventional hip arthroplasty by gender, age, body mass index (BMI), and preoperative activity level. Mean preoperative Harris hip scores and length of follow-up were similar for the two groups. Postoperative weighted activity scores, Harris hip scores, patient satisfaction score, pain scores, and revision rates were evaluated at a mean fnal follow-up of 42 months (range, 25 to 68 months) for the resurfacing group and 45 months (range, 24 to 67 months) for the conventional hip group, and analyzed for differences. Results: At fnal follow-up, activity levels were signifcantly higher in the resurfacing group, with a mean weighted activity score of 10.0 points (range, 1.0 to 27.5 points), as compared to a mean score of 5.3 points (range, 0 to 12.0 points) in the THA group. Mean Harris hip scores, patients satisfaction scores, and pain scores were similar for both groups. There were no revisions in either group. Conclusions: The results of this study suggest that pa- tients treated with hip resurfacing arthroplasty have a sig- nifcantly higher postoperative activity level, as compared to those treated with conventional THA, when controlled for preoperative factors.

Resurfacing Versus Conventional Total Hip Arthroplasty - Review of Comparative Clinical and Basic Science Studies

David R. Marker, B.S., Kyle Strimbu, B.S., Mike S. McGrath, M.D., Michael G. Zywiel, M.D., and Michael A. Mont, M.D.

ABSTRACT
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Objective: Although standard total hip arthroplasties have a long and successful history as the standard of care for advanced, symptomatic osteoarthritis, there is increasing patient demand and surgeon interest in femoral boneconserving resurfacing alternatives. The purpose of this study was to assess the state of the research that directly compares the outcomes of conventional total hip arthroplasty procedures with the current generation of metal-on-metal resurfacing hip arthroplasties. Methods: A comprehensive review was performed of the published literature that directly compared total hip arthroplasty and resurfacing hip arthroplasty and that considered basic science, radiographic, and clinical studies. Results: Of the basic science studies, two investigations found evidence that favored total hip arthroplasty, while three favored resurfacing hip arthroplasty. For the clinical studies, all reports showed that resurfacing hip arthroplasty had similar or better outcomes than total hip arthroplasty at short- to midterm follow-up. The gait studies suggest that resurfacing provides a more natural gait than conventional total hip arthroplasty. Conclusions: While there is still much debate and room for additional research on this topic, multiple midterm clinical results suggest that resurfacing hip arthroplasty represents a safe, effective alternative to conventional total hip arthroplasty, especially for younger, active patients.

Canadian Academic Experience with Metal-on-Metal Hip Resurfacing

Michelle O’Neill, M.D., F.R.C.S.(C), Paul E. Beaulé, M.D., F.R.C.S.(C), Ahmad Bin Nasser, M.D., F.R.C.S.(C), Donald Garbuz, M.D., F.R.C.S.(C), Martin Lavigne, M.D., F.R.C.S.(C), Clive Duncan, M.D., F.R.C.S.(C), Paul R. Kim, M.D., F.R.C.S.(C), and Emil Schemitsch, M.D., F.R.C.S.(C)

ABSTRACT
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The current depth and breadth of experience in hip resurfacing in Canadian academic centers is not well known. This study endeavors to increase awareness of the prevalence of programs and current experience in a select number of representative teaching centers by examining the learning curve of high-volume surgeons. A questionnaire was sent to all academic centers in Canada to identify the volume of hip resurfacing, surgical approach, and type of prosthesis. In addition, fve surgeons, not fellowship-trained in hip resurfacing, were selected for a detailed review of their frst 50 cases, including survey of patient demographics, surgical approach, radiographic evaluation, complications, and revision. Eleven of 14 academic centers are currently performing hip resurfacing. All of these centers had performed more than 50 cases, with 10 of 11 of them having more than one surgeon performing the procedure. The posterior approach was found to be the most commonly utilized in surgeries. The overall revision rate was 3.2% at a mean time of 2 years, with femoral neck fracture (1.6%) being the most common cause for failure. The failure rate was comparable to other centers of expertise and lower than previously published multicenter trials. All surgeons reviewed were in specialized arthroplasty practices, which may contribute to the relatively low complication rates reported.

The Early Results of Metal-on-Metal Hip Resurfacing - A Prospective Study at a Minimum Two-Year Follow-Up

Stephane G. Bergeron, M.D., Nicholas M. Desy, M.D., Vassilios S. Nikolaou, M.D., Ph.D., Kevin Debiparshad, M.D., and John Antoniou, M.D., Ph.D.

ABSTRACT
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Hip resurfacing has recently been offered as an attractive alternative to conventional total hip arthroplasty. This report evaluated the short-term functional outcome and longevity of a newer generation resurfacing device and includes the results of 228 consecutive hip resurfacings in 209 patients at a minimum of two-year follow-up. All resurfacings were performed by a single surgeon using a posterior approach. Excluding infections, there were only three failures (1.3%). The overall survival at 4.6 years was 96.9%. The survival of resurfacing in this study was comparable to that of other published studies of hip resurfacing. Surface hip arthroplasty appears to be an effective alternative to conventional total hip arthroplasty in patients suffering from osteoarthritis.

Extra-Articular Deformities and the Role of Hip Resurfacing - A Proposed Classifcation System

Steven A. Stuchin, M.D.

ABSTRACT
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There has been an increasing demand for hip resurfacing as an alternative to total hip arthroplasty. A number of reports have been published recently detailing the technique and role of resurfacing in a variety of extra-articular deformities, dysplastic conditions, and settings of retained intramedullary hardware and other impediments. The following report proposes a classifcation system that recognizes intramedullary and extramedullary deformities. With the long-term expectation for resurfacing, these complex situations may require categorization to segregate risk factors in order to allow for better planning and prognostication.

Resurfacing Arthroplasty for Patients with Osteonecrosis

Bernard N. Stulberg, M.D., Stephanie M. Fitts, Ph.D., Jayson D. Zadzilka, M.S., and Kathy Trier, Ph.D.

ABSTRACT
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The suitability of third-generation metal-on-metal hip resurfacing products for patients with a primary diagnosis of osteonecrosis has been debated. The preservation of femoral head bone stock for femoral prosthetic support is essential for the long-term stability of implants. A modern hip resurfacing system was implanted in 1148 hips as part of a United States multicenter investigational device exemption study. Of these, 116 hips had a preoperative diagnosis of osteonecrosis and were compared to 1023 hips with osteoarthritis. Survival rates were not signifcantly different (95.9% and 95.8% at 24 months for osteoarthritis and osteonecrosis respectively, p = 0.46). Resurfacing arthroplasty for patients with osteonecrosis appears to be a reasonable alternative, taking into consideration implant size, patient gender, and size of femoral defciency. Further characterization is needed to identify those specifc patients with osteonecrosis for whom resurfacing arthroplasty would be appropriate.

Hip Resurfacing—Keys to Success

Cara M. Maguire, B.S., Thorsten M. Seyler, M.D., Harold S. Boyd, M.D., Lawrence P. Lai, M.D., M.S., Ronald E. Delanois, M.D., and Riyaz H. Jinnah, M.D., F.R.C.S.

ABSTRACT
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In recent years, metal-on-metal hip resurfacing has become an increasingly popular treatment for patients needing hip arthroplasty. Important factors to consider for a successful outcome include proper patient selection and surgical technique, including approach, component positioning, and cementing technique. This review will serve as guide to both those who are learning the technique of hip resurfacing and to more experienced surgeons.

Cement Technique Changes Improved Hip Resurfacing Longevity - Implant Retrieval Findings

Pat Campbell, Ph.D., Karren Takamura, B.A., William Lundergan, B.A., Christina Esposito, B.A., and Harlan C. Amstutz, M.D.

ABSTRACT
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Background: Most designs of metal-on-metal hip resurfacing utilize cement for femoral fxation, but the amount, application, and distribution of cement varies considerably according to implant design and surgeon preference. In one type of hip resurfacing system (Conserve® Plus), the objective was to achieve a 1-mm cement mantle and several millimeters of penetration. In early cases of the senior investigator’s (HCA) series, cement fxation failures were noted, and this prompted changes in femoral head preparation and cement application techniques. Survivorship improved following implementation of these changes. The aim of the current study was to examine revised femoral components for the cement distribution, especially in cases where the improved techniques were subsequently applied. Method: Fifteen resurfacing femoral components were sectioned and the slices were radiographed and photographed, and the amount and distribution of cement were examined and measured. Cases representative of the evolving cementing techniques were examined in detail. Results: There was considerable variation observed in the amount and distribution of cement, partly as a consequence of variable bone quality in this “all-comers” included series. The cement analyses showed that the newer cementing techniques helped to reduce over-penetration while providing better cement interdigitation. The use of extra fxation holes and cementing the stem in cases with poor bone quality were associated with improved cement-to-bone contact area. Conclusion: Meticulous femoral head preparation was helpful in providing durable cement fxation and is essential in cases with poor bone quality.

Quantifying Degree of Diffculty in Hip - Resurfacing of Pistol-Grip Deformity

Burton Ma, Ph.D., Stephane G. Bergeron, M.D., Heather J. Grant, M.Sc., John Rudan, M.D., and John Antoniou, M.D., Ph.D.

ABSTRACT
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This study used computer simulation to endeavor to quantify the relative degree of difficulty of resurfacing femora with pistol-grip deformities compared to relatively normal femora. Computer models of five pistol-grip femora and one relatively normal femur were computed from computed tomography (CT) scans of patients who had undergone computer-assisted hip resurfacing. A computer simulation of positioning the femoral resurfacing component on the femur was performed to count the number of acceptable configurations of the component on the femur. A high number of acceptable configurations implies that the surgeon has greater freedom, or greater margin for error, in implanting the component compared to a femur with a smaller number of acceptable configurations. We found that pistol-grip deformities dramatically reduce the number of acceptable configurations for valgus alignment, and that such configurations result in decreased femoral offset and increased depth of reaming.

Computer Navigated Hip Resurfacing for Patients with Abnormal Femoral Anatomy

Michael Olsen, B.Sc., and Emil H. Schemitsch, M.D., F.R.C.S.(C)

ABSTRACT
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Hip resurfacing is a technically demanding alternative to total hip arthroplasty. The use of traditional jigs for placement of the femoral guidewire can lead to preparatory errors that may predispose the resurfacing construct to premature failure. Computer navigation is a tool that can be used to minimize the incidence of inadequate to detrimental preparation of the femoral head and improve the accuracy of component placement. Computer navigation not only shows promise in routine cases of hip resurfacing but also in those cases that are technically challenging. The current study demonstrated the utility of imageless computer navigation in placement of the femoral component for patients presenting with abnormal femoral anatomy.

Computer-Assisted Navigation in Hip Resurfacing Arthroplasty - A Single-Surgeon Experience

John S. Shields, M.D., Thorsten M. Seyler, M.D., Cara Maguire, B.S., and Riyaz H. Jinnah, M.D.

ABSTRACT
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Hip resurfacing arthroplasty is a technically challenging procedure, and orientation of the femoral component is critical to avoid implant failure. The use of computer-assisted navigation has been shown to decrease the learning curve for beginners in hip resurfacing and to improve the surgeon’s ability to produce consistent results. Computer navigation offers real-time feedback, with the opportunity to produce improved repeatability to optimize patient outcomes. The purpose of this study was to evaluate the learning curve of computer-assisted surgery in the hands of an experienced hip resurfacing surgeon. A retrospective review of 100 consecutive navigated hip resurfacing arthroplasties in 94 patients assessed preoperative and postoperative neck-shaft angles, operative times, and complications. Twenty-fve non-navigated hip resurfacing arthroplasties, performed by the same surgeon, were evaluated as a matching group. Mean operative times for the computer-assisted hip resurfacings were 101 minutes, as compared to 104 minutes in the non-navigated group. We found that in the hands of an experienced hip resurfacing surgeon, the addition of computer-assisted navigation had no effect on the learning curve, but did provide feedback and repeatability to the surgeon.

Evaluation of Persistent Pain After Hip Resurfacing

Vassilios S. Nikolaou, M.D. Ph.D., Stephane G. Bergeron, M.D., Olga L. Huk, M.D., M.Sc., David J. Zukor, M.D., and John Antoniou, M.D., Ph.D

ABSTRACT
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Evaluation and treatment of pain following hip resurfacing arthroplasty can be challenging, even for the most experienced arthroplasty surgeon. As in any total hip replacement, there are a number of investigative tools at the disposal of orthopaedic surgeons to elicit the underlying causes of pain for diagnosis and treatment. A detailed history and physical examination are the most important frst steps in the differential diagnosis of the intrinsic and extrinsic etiologies of hip pain. Serial radiographs from the time of surgery also should be reviewed and compared for changes indicative of loosening, migration, and osteolysis, in combination or alone. Diagnostic injections with local anesthetic agents additionally can be performed to localize the origin of pain. Bone scintigraphy, hip joint aspiration, and laboratory tests, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), should be requested routinely to exclude an occult infection. The use of ultrasound (US), magnetic resonance imaging (MRI), and even hip arthroscopy has been suggested as potential diagnostic tools when metal sensitivity is suspected. Relative to cause, femoral neck fractures and the possibility of metal hypersensitivity as sources of persistent groin pain should always be considered in metal-on-metal hip resurfacing. Additionally, iliopsoas tendinopathy and anterior impingement of the femoral neck are well-recognized causes of pain and should be included in the differential diagnosis. Surface arthroplasty is becoming an acceptable alternative to standard total hip replacement in young patients. It is increasingly essential to recognize the different causes of pain following resurfacing in order to make an accurate diagnosis and initiate timely, appropriate treatment.

Posterior Femoroacetabular Impingement (PFAI) - After Hip Resurfacing Arthroplasty

Scott T. Ball, M.D., and Thomas P. Schmalzried, M.D.

ABSTRACT
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Introduction: The recent, encouraging outcome literature on hip resurfacing arthroplasty (HRA) has not suffciently examined the potential occurrence of postoperative femoroacetabular impingement (PFAI) and sequelae. The current study asks the questions, “Does femoroacetabular impingement occur after hip resurfacing arthroplasty (HRA) and, if so, what are the clinical outcomes?” Methods: Sixty-nine consecutive hips in 57 patients with a minimum of 2 years clinical and radiographic follow-up were evaluated. Both acetabular and femoral component positions and postsurgical changes in the femoral neck and acetabulum were recorded. Results: Fourteen hips in 13 patients (20%) developed a small scalloped, corticated erosion in the posterior neck, just distal to the femoral component and adjacent to the acetabular component rim. These erosions were between 5 and 10 mm in depth and became apparent at an average of 15 months (range, 6 to 24 months) following surgery. After 2 years, they showed no further progression. The location and shape of the erosions indicate PFAI as the etiology. One hip also demonstrated similar changes in the anterior neck. The Harris Hip Score and UCLA (University of California at Los Angeles) Activity Scores were higher in patients with such erosions (97.5 and 9.2, respectively), compared to those patients without (93.5 and 8.4, respectively). Additionally, patients with erosions reported slightly better pain relief on average than patients with no radiographic evidence of impingement. No signifcant differences in range of motion or component position were found between the two groups. Conclusions: Small, corticated, non-progressive erosions can occur from femoroacetabular impingement following HRA. The erosions were more commonly posterior in this series, and they tended to occur in active patients. There is no adverse effect on clinical outcomes, and more specifcally, there is no association of PFAI with pain.

Range of Motion After Stemmed Total Hip Arthroplasty and Hip Resurfacing - A Clinical Study

Michel J. Le Duff, M.A., Lauren E. Wisk, B.S., and Harlan C. Amstutz, M.D.

ABSTRACT
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Range of motion after total hip arthroplasty is becoming an important topic as today’s patients present at a younger age and are more active. An effective study design to carry out comparisons of clinical performance between two implants should eliminate patient-related extraneous variables (e.g., age, gender, activity level, among others). The aim of the present study was to compare the range of motion results achieved postoperatively between metalon-metal hip resurfacing (HR) and conventional total hip arthroplasty (THA) in a cohort of bilateral patients implanted with both designs. Thirty-five patients who had undergone bilateral surgery with one hip receiving an HR device and the contralateral hip receiving a THA were retrospectively selected. Sixty-nine percent of the patients were male, and at the time of implantation of the resurfacing device the mean age of the patients was 53 years. The mean follow-up time was 88 months for the hips treated with HR and 96 months for the hips that received a THA. We found no difference in any of the range of motion measurements between HR and THA even after separating the cohort into two groups based on the femoral head size of the THA (femoral heads under 40 mm and femoral heads greater or equal to 40 mm). Our investigation showed that, for most patients, prosthetic design is unlikely to be a limiting factor of range of motion after surgery provided that the positioning of the acetabular component is adequate.

Biologic Effects of Implant Debris

Nadim J. Hallab, Ph.D., and Joshua J. Jacobs, M.D.

ABSTRACT
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Biologic response to orthopedic implants debris is central to clinical performance. Eventual implant loosening due to aseptic osteolysis has been attributed to local infammatory responses to wear and corrosion products that are produced by articulating implant interfaces. The response to implant debris is dominated by local immune activation, e.g. macrophages. Immune reactivity has been shown to depend on the number of particles produced or the dose (i.e., the concentration of phagocytosable particles per tissue volume, which can be characterized by knowing the size distribution and amount of debris). Elongated particles (fbers) are generally more pro-infammatory than round particles, and there is a growing consensus that metals particles are more proinfammatory than polymers in vivo. Generally, to produce an in vitro infammatory response, particles need to be less than 10 μm, i.e. phagocytosable. However, both soluble and particulate debris derived from Co-Cr-Mo alloy implants can induce monocyte/macrophage activation and secretion of pro-infammatory cytokines such as IL-1β, TNFα, IL-6 and IL-8 via up-regulation of transcription factor NFκβ, and activation of infammasome danger signaling in human macrophages. Not only does activation of local (and systemic) infammation result in decreased osteoblast function but osteoclast activity increases. Some people are more predisposed to implant debris induced infammation and metal “allergy” testing services are becoming available. New pathways of implant debris-induced infammatory reactions continue to be discovered, such as the “danger signaling” infammasome pathway, which provides new targets for pharmaceutical intervention and improved implant performance.

The Problem with Large Diameter Metal-on-Metal Acetabular Cup Inclination

Jonathan R.T. Jeffers, Ph.D., Anne Roques, Ph.D., Andy Taylor Ph.D., and Mike A. Tuke, HNC Mech Eng

ABSTRACT
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Large diameter metal-on-metal hip bearings have proven to be clinically successful in active patients, but, in a small number, they are associated with elevated wear and high metal ion levels when cup inclination angles are too steep and the version is too extreme, or either alone. Based on the geometry of six different commercially available large diameter metal-on-metal acetabular components, this study demonstrated that the critical bearing surface operates at an angle up to 16º greater than the cup face inclination. Due to geometry alone, measured cup inclination is not the angle that most surgeons perceive it to be. We strongly recommend when employing large diameter metal-on-metal bearings that lower inclination and version angles are targeted to prevent excessive wear.

Proceedings from the NYU Hospital for Joint Diseases Clinical Research Methodology Course 2008

Methods to Analyze Real-World Databases and Registries

Hilal Maradit Kremers, M.D., M.Sc.

ABSTRACT
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Observational studies, administrative database studies, and registries offer a wealth of real-world information, if designed, maintained, and analyzed according to appropriate observational study methodology. This review summarizes basic observational study methods employed in rheumatology and highlights several notable examples. In response to growing interest in real-world effectiveness and safety data, registries are expected to proliferate in the near future. The availability of detailed clinical information in registries coupled with powerful tools for analysis offers promise for timely and accurate information on the safety and effectiveness of rheumatic treatments.

Evidence-Based Medicine and The Cochrane Collaboration

Elizabeth Tanjong-Ghogomu, M.D., M.Sc., Peter Tugwell, M.D., F.C.A.R.P., M.Sc. and Vivian Welch

ABSTRACT
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Providing evidence-based care to patients involves turning a clinical problem into an answerable question, systematically searching for the best evidence relevant to the question, critically appraising that evidence, and, fnally, using the evidence as the basis for clinical decisions to solve the problem. While the overload of medical information today presents a demanding challenge to physicians to sort and identify relevant and valid evidence, it is vitally important to translate that evidence into clinically useful terms. To apply evidence to patient clinical management, it is critical to discuss with patients the evidence, the benefts and the harms, and the alternative treatments, such that they understand and can fully participate in the decision-making process. The framework of evidenced-based medicine provides a concrete methodology to address these issues, here, framed and detailed in fve steps. The Cochrane Collaboration has been at the forefront of applying the methods of evidence-based medicine (EBM) in the treatment and management of musculoskeletal and other disorders.

Diagnostic Versus Classification Criteria - A Continuum

Hasan Yazici, M.D.

ABSTRACT
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The current understanding that disease criteria are different than classifcation criteria is not well founded. In fact, they are a continuum. The arithmetic behind the two are the same and is built on a clear understanding of the concepts of sensitivity and specifcity. Diagnosis is nothing different than classifcation in the individual patient. The main element that makes a set of criteria diagnostic is the pretest odds. We should question our current practice of making universal disease criteria and perhaps design criteria tailored to subspecialties.

Safety Reporting in Randomized Clinical Trials - A Need for Improvement

Yusuf Yazici, M.D.

ABSTRACT
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The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of “time to event,” use of standardized incidence ratios for comparison to normal population or disease controls, use of “patient years” when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs.

RAPID3—An Index of Physical Function, Pain, and Global Status as “Vital Signs” to Improve Care for People with Chronic Rheumatic Diseases

Theodore Pincus, M.D., Martin J. Bergman, M.D., F.A.C.R., F.A.C.P., and Yusuf Yazici, M.D.

ABSTRACT
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A guide to RAPID3 (routine assessment of patient index data), an index of three patient self-report measures—physical function, pain, and patient global estimate of status—on a multidimensional health assessment questionnaire (MDAQ) is presented, including development, scoring, use in standard care, and rationale. RAPID3 and its individual components are regarded as “vital signs,” which may alert a health professional to unsuspected patient problems, provide a baseline measure to support a change in therapy, and numerically document improvement or worsening over time to complement clinical impressions. MDHAQ-RAPID3 can be incorporated into the infrastructure of standard rheumatology care for completion in the waiting room by every patient with any rheumatic disease at every visit: if there is a reason for a visit, there is a reason for RAPID3 vital signs. RAPID3 is calculated in 5 to 10 seconds, providing similar information to DAS28 (disease activity score) and CDAI (clinical disease activity index), which require a mean of 114 and 106 seconds, respectively. MDHAQ-RAPID3 presents an additional advantage for the patient to optimize the offce encounter by completion of the questionnaire in the waiting room. The MDHAQ also includes a review of systems and recent medical history, which can save 2 to 3 minutes per visit for other patient concerns. A physician’s clinical decisions ultimately require synthesis and interpretation of all available data, ranging from laboratory tests to patient questionnaire scores. RAPID3 vital signs can contribute to this synthesis toward improved quality, outcomes, and documentation of rheumatology care.

What Can We Learn from Design Faults in the Women’s Health Initiative Randomized Clinical Trial?

Orkun Tan, M.D., S. Mitchell Harman, M.D., Ph.D., and Frederick Naftolin, M.D., Ph.D.

ABSTRACT
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Design faults resulted in the inability of the Women’s Health Initiative (WHI) randomized clinical trial to test the level of cardioprotection conferred by timely hormone treatment of women seeking help for menopausal complaints. Adopting a design constructed around the avoidance of symptomatic subjects and recruitment of older subjects who were more likely to manifest cardiovascular events during the life of the WHI resulted in recruitment of older, sicker subjects than are normally treated for complaints around the time of menopause. The lack of cardioprotection in subjects that began treatment a decade or more after menopause diluted ardioprotection in subjects starting treatment close to the menopausal transition. As a result, despite having the largest number of subjects ever, there were not enough women in the WHI who were comparable to those in the observational trials that showed cardioprotection. This led the WHI to report that there was no cardioprotection in the trial, a position that has been qualifed after further analysis. Misapprehension of the initial WHI conclusions by the media, professionals, and regulatory agencies led to a major shift away from menopausal hormone treatment. This remains problematic since the evidence continues to favor cardioprotection and other benefts that are denied under present regulations and guidelines. Regulatory agencies and professional organizations need to better understand the faws in the WHI design and results in order to properly consider its results and the sustainability of their earlier conclusions and recommendations. Additionally, new trials are needed to test the validity of menopausal hormone-related cardioprotection.

Original Articles

Arthritis as a Risk Factor for Incident Coronary Heart Disease in Elderly Japanese-American Males - The Honolulu Heart Program

Mitsumasa Kishimoto, M.D., Ph.D., Jeffrey Greenberg, M.D., M.P.H., Ryan Lee, B.S., Kamal H. Masaki, M.D., Randi Chen, M.S., Beatriz L. Rodriguez, M.D., Ph.D., Patricia L. Blanchette, M.D., M.P.H., Michael H. Pillinger, M.D., and J. David Curb, M.D.

ABSTRACT
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Background: Arthritis is the most common chronic disease in the elderly. Studies show that rheumatoid arthritis is a risk factor for cardiovascular morbidity and mortality, and osteoarthritis is associated with an unfavorable cardiovascular risk factor profle. Methods: At the Honolulu Heart Program’s fourth examination in 1991 to 1993, arthritis status was assessed among a cohort of 3741 Japanese-American males, ages 71 to 93 years. Arthritis was determined by self-report of physician diagnosis, and subjects were divided into two groups: current arthritis and no current arthritis. Eight years of follow-up data are available for incident coronary heart disease (CHD) in 2777 subjects free of CHD at baseline. Age-adjusted rates of incident CHD and means of cardiovascular risk factors were compared in each group. Cox proportional hazards models were used to calculate relative risks, adjusting for common cardiovascular risk factors, alcohol, and use of aspirin or NSAIDs, or both. Results: There were 279 cases of incident CHD in the cohort over 8 years; in those with arthritis, 11.7% developed incident CHD, compared to 9.8% in those without arthritis (p = 0.24). Age-adjusted rates of incident CHD in those with and without arthritis were 20.5 and 18.0 per 1000 person-years, respectively (p = 0.25). Arthritis was not signifcantly associated with CHD risk factors. Arthritis was not a signifcant independent predictor of incident CHD (relative risk, 1.06; 95% CI, 0.74 to 1.51). Conclusions: Arthritis, and most probably osteoarthritis, may not be associated with most CHD risk factors or 8-year incident CHD in elderly Japanese-American males.

Monitoring Response to Therapy in Rheumatoid Arthritis - Perspectives from the Clinic

Patricia Daul, R.N., and Joseph Grisanti, M.D.

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The major objectives in treating patients with rheumatoid arthritis are managing the symptoms of disease and preserving joint structure, with the ultimate goal of disease remission. Several independent studies have shown that treatment decisions driven by quantitative rather than subjective monitoring of disease activity result in signifcantly improved patient outcomes. Various assessment tools are available that measure both clinical and patient-reported outcomes. While some measurement tools may be more appropriate for use in clinical trials, several have been developed that are simple and practical to use, even in a busy clinic. As pivotal members of the multidisciplinary rheumatology healthcare provider team, the nurse and the rheumatologist play key roles in managing a patient’s progress by closely monitoring their response to treatment. Here, we discuss optimal disease management founded on a multidisciplinary approach and provide an overview of some key measures for assessing patient response to treatment.

Second annual United States comprehensive course on total hip re-surfacing arthroplasty 2008

Perceptions Concerning Hip Resurfacing from Attendees at The Second Annual U.S. Comprehensive Course on Total Hip Resurfacing Arthroplasty

Michael A. Mont, M.D., Thomas P. Schmalzried, M.D., Michael G. Zywiel, M.D., Mike S. McGrath, M.D., and Thorsten M. Seyler, M.D.

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Resurfacing hip arthroplasty represents a new, alternative technology to standard total hip arthroplasty. We examined the perceptions about resurfacing after the Second Annual United States Comprehensive Course on Total Hip Resurfacing Arthroplasty, which was a multi-company sponsored educational event to advance general knowledge, basic science, and surgical skills relevant to this feld. The course led to a substantial increase in knowledge concerning resurfacing as evaluated from pre- and post-tests. The perceptions concerning indications, patient selection, and beliefs of the course attendees are reported.

A Comparison of Total Hip Resurfacing and Total Hip Arthroplasty - Patients and Outcomes

Vincent A. Fowble, M.D., Mylene A. dela Rosa, B.S., C.C.R.P., and Thomas P. Schmalzried, M.D.

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A comparison of pertinent preoperative and postoperative data relative to total hip resurfacing versus total hip arthroplasty (THA) would assist in evaluating current perceptions in outcome. We compared 50 consecutive metal-metal resurfacing replacements in 50 patients with 44 consecutive conventional total hip arthroplasties in 35 patients, who were implanted during the same time period, by the same surgeon, and followed prospectively for 2 to 4 years. The patients undergoing hip resurfacing were 62% male, 9 years younger, and 3.2 inches taller, with a lower mean body mass index and American Society of Anesthesiologists (ASA) grade than patients undergoing total hip arthroplasty. Preoperatively, patients undergoing resurfacing had a lower Harris hip score (46 vs 52 points), more pain, higher UCLA (University of California at Los Angeles) activity scores (4.2 vs 3.6), and better range of motion. Surgical time for resurfacing was 18% longer, but there was less total blood loss and fewer transfusions. Postoperatively, there was no difference in Harris hip score (97 vs 96). Patients undergoing resurfacing had higher function, Short Form-12 physical activity scores, and UCLA activity scores, but also a higher incidence of slight or mild pain. There were no differences in postoperative range of motion or dislocation (one each). The preoperative characteristics and general health status of the average patient undergoing resurfacing are more favorable than that of the average patient undergoing conventional total hip arthroplasty. Caution should be applied in attributing differences in outcomes directly to the arthroplasty technology.

Minimally Invasive Hip Resurfacing Compared to Minimally Invasive Total Hip Arthroplasty

Michael L. Swank, M.D., and Martha R. Alkire, C.N.P.

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Background: Since its March 2006 FDA approval in the United States, Birmingham hip resurfacing (BHR) has been a popular alternative to hip arthroplasty for the younger patient population. Data to date has shown a trend toward low incidence of dislocation and good survivorship. Methods: 128 patients operated on by a single surgeon from July 2006 to December 2008 were reviewed for complications, pain, and function. A group of single incision, minimally invasive standard total hip replacements (106 cases) in 2008 was used for comparison of the same outcomes. Conclusion: Pain, function, and total Harris Hip scores were all improved by the 2 year mark and better than the total hip group. Overall incision lengths decreased over the study time period. The average age of the BHR recipient was 51 years, approximately 14 years less than the total hip mean age. Pain in the Birmingham group improved by 32 points at the 3 month mark. By the end of 2 years, the Birmingham group Harris Hip score mean was nearly perfect at 98.5 points. Rare incidence of complications, marked decreased pain scores and marked elevation in function were results found in this sample of Birmingham resurfacing.

Resurfacing Matched to Standard Total Hip Arthroplasty by Preoperative Activity Levels - A Comparison of Postoperative Outcomes

Michael G. Zywiel, M.D., David R. Marker, B.S., Mike S. McGrath, M.D., Ronald E. Delanois, M.D., and Michael A. Mont, M.D.

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Background: Some studies have suggested that resurfacing patients are generally more active postoperatively than their conventional total hip arthroplasty (THA)counterparts, but controversy remains over whether this is a refection of preferential use of resurfacing for younger and higher-activity patients. We hypothesized that, when controlling for preoperative activity levels, in addition to relevant clinical and demographic factors, resurfacing provides similar results to conventional hip arthroplasty. Materials and Methods: The specifc question asked was whether resurfacing patients had differences in postoperative activity level, clinical outcomes, or rate of revisions, as compared to a matched cohort of patients treated with conventional THA. Thirty-three patients (23 men and 10 women) who were treated with resurfacing arthroplasties were matched to a cohort of patients who underwent conventional hip arthroplasty by gender, age, body mass index (BMI), and preoperative activity level. Mean preoperative Harris hip scores and length of follow-up were similar for the two groups. Postoperative weighted activity scores, Harris hip scores, patient satisfaction score, pain scores, and revision rates were evaluated at a mean fnal follow-up of 42 months (range, 25 to 68 months) for the resurfacing group and 45 months (range, 24 to 67 months) for the conventional hip group, and analyzed for differences. Results: At fnal follow-up, activity levels were signifcantly higher in the resurfacing group, with a mean weighted activity score of 10.0 points (range, 1.0 to 27.5 points), as compared to a mean score of 5.3 points (range, 0 to 12.0 points) in the THA group. Mean Harris hip scores, patients satisfaction scores, and pain scores were similar for both groups. There were no revisions in either group. Conclusions: The results of this study suggest that pa- tients treated with hip resurfacing arthroplasty have a sig- nifcantly higher postoperative activity level, as compared to those treated with conventional THA, when controlled for preoperative factors.

Resurfacing Versus Conventional Total Hip Arthroplasty - Review of Comparative Clinical and Basic Science Studies

David R. Marker, B.S., Kyle Strimbu, B.S., Mike S. McGrath, M.D., Michael G. Zywiel, M.D., and Michael A. Mont, M.D.

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Objective: Although standard total hip arthroplasties have a long and successful history as the standard of care for advanced, symptomatic osteoarthritis, there is increasing patient demand and surgeon interest in femoral boneconserving resurfacing alternatives. The purpose of this study was to assess the state of the research that directly compares the outcomes of conventional total hip arthroplasty procedures with the current generation of metal-on-metal resurfacing hip arthroplasties. Methods: A comprehensive review was performed of the published literature that directly compared total hip arthroplasty and resurfacing hip arthroplasty and that considered basic science, radiographic, and clinical studies. Results: Of the basic science studies, two investigations found evidence that favored total hip arthroplasty, while three favored resurfacing hip arthroplasty. For the clinical studies, all reports showed that resurfacing hip arthroplasty had similar or better outcomes than total hip arthroplasty at short- to midterm follow-up. The gait studies suggest that resurfacing provides a more natural gait than conventional total hip arthroplasty. Conclusions: While there is still much debate and room for additional research on this topic, multiple midterm clinical results suggest that resurfacing hip arthroplasty represents a safe, effective alternative to conventional total hip arthroplasty, especially for younger, active patients.

Canadian Academic Experience with Metal-on-Metal Hip Resurfacing

Michelle O’Neill, M.D., F.R.C.S.(C), Paul E. Beaulé, M.D., F.R.C.S.(C), Ahmad Bin Nasser, M.D., F.R.C.S.(C), Donald Garbuz, M.D., F.R.C.S.(C), Martin Lavigne, M.D., F.R.C.S.(C), Clive Duncan, M.D., F.R.C.S.(C), Paul R. Kim, M.D., F.R.C.S.(C), and Emil Schemitsch, M.D., F.R.C.S.(C)

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The current depth and breadth of experience in hip resurfacing in Canadian academic centers is not well known. This study endeavors to increase awareness of the prevalence of programs and current experience in a select number of representative teaching centers by examining the learning curve of high-volume surgeons. A questionnaire was sent to all academic centers in Canada to identify the volume of hip resurfacing, surgical approach, and type of prosthesis. In addition, fve surgeons, not fellowship-trained in hip resurfacing, were selected for a detailed review of their frst 50 cases, including survey of patient demographics, surgical approach, radiographic evaluation, complications, and revision. Eleven of 14 academic centers are currently performing hip resurfacing. All of these centers had performed more than 50 cases, with 10 of 11 of them having more than one surgeon performing the procedure. The posterior approach was found to be the most commonly utilized in surgeries. The overall revision rate was 3.2% at a mean time of 2 years, with femoral neck fracture (1.6%) being the most common cause for failure. The failure rate was comparable to other centers of expertise and lower than previously published multicenter trials. All surgeons reviewed were in specialized arthroplasty practices, which may contribute to the relatively low complication rates reported.

The Early Results of Metal-on-Metal Hip Resurfacing - A Prospective Study at a Minimum Two-Year Follow-Up

Stephane G. Bergeron, M.D., Nicholas M. Desy, M.D., Vassilios S. Nikolaou, M.D., Ph.D., Kevin Debiparshad, M.D., and John Antoniou, M.D., Ph.D.

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Hip resurfacing has recently been offered as an attractive alternative to conventional total hip arthroplasty. This report evaluated the short-term functional outcome and longevity of a newer generation resurfacing device and includes the results of 228 consecutive hip resurfacings in 209 patients at a minimum of two-year follow-up. All resurfacings were performed by a single surgeon using a posterior approach. Excluding infections, there were only three failures (1.3%). The overall survival at 4.6 years was 96.9%. The survival of resurfacing in this study was comparable to that of other published studies of hip resurfacing. Surface hip arthroplasty appears to be an effective alternative to conventional total hip arthroplasty in patients suffering from osteoarthritis.

Extra-Articular Deformities and the Role of Hip Resurfacing - A Proposed Classifcation System

Steven A. Stuchin, M.D.

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There has been an increasing demand for hip resurfacing as an alternative to total hip arthroplasty. A number of reports have been published recently detailing the technique and role of resurfacing in a variety of extra-articular deformities, dysplastic conditions, and settings of retained intramedullary hardware and other impediments. The following report proposes a classifcation system that recognizes intramedullary and extramedullary deformities. With the long-term expectation for resurfacing, these complex situations may require categorization to segregate risk factors in order to allow for better planning and prognostication.

Resurfacing Arthroplasty for Patients with Osteonecrosis

Bernard N. Stulberg, M.D., Stephanie M. Fitts, Ph.D., Jayson D. Zadzilka, M.S., and Kathy Trier, Ph.D.

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The suitability of third-generation metal-on-metal hip resurfacing products for patients with a primary diagnosis of osteonecrosis has been debated. The preservation of femoral head bone stock for femoral prosthetic support is essential for the long-term stability of implants. A modern hip resurfacing system was implanted in 1148 hips as part of a United States multicenter investigational device exemption study. Of these, 116 hips had a preoperative diagnosis of osteonecrosis and were compared to 1023 hips with osteoarthritis. Survival rates were not signifcantly different (95.9% and 95.8% at 24 months for osteoarthritis and osteonecrosis respectively, p = 0.46). Resurfacing arthroplasty for patients with osteonecrosis appears to be a reasonable alternative, taking into consideration implant size, patient gender, and size of femoral defciency. Further characterization is needed to identify those specifc patients with osteonecrosis for whom resurfacing arthroplasty would be appropriate.

Hip Resurfacing—Keys to Success

Cara M. Maguire, B.S., Thorsten M. Seyler, M.D., Harold S. Boyd, M.D., Lawrence P. Lai, M.D., M.S., Ronald E. Delanois, M.D., and Riyaz H. Jinnah, M.D., F.R.C.S.

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In recent years, metal-on-metal hip resurfacing has become an increasingly popular treatment for patients needing hip arthroplasty. Important factors to consider for a successful outcome include proper patient selection and surgical technique, including approach, component positioning, and cementing technique. This review will serve as guide to both those who are learning the technique of hip resurfacing and to more experienced surgeons.

Cement Technique Changes Improved Hip Resurfacing Longevity - Implant Retrieval Findings

Pat Campbell, Ph.D., Karren Takamura, B.A., William Lundergan, B.A., Christina Esposito, B.A., and Harlan C. Amstutz, M.D.

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Background: Most designs of metal-on-metal hip resurfacing utilize cement for femoral fxation, but the amount, application, and distribution of cement varies considerably according to implant design and surgeon preference. In one type of hip resurfacing system (Conserve® Plus), the objective was to achieve a 1-mm cement mantle and several millimeters of penetration. In early cases of the senior investigator’s (HCA) series, cement fxation failures were noted, and this prompted changes in femoral head preparation and cement application techniques. Survivorship improved following implementation of these changes. The aim of the current study was to examine revised femoral components for the cement distribution, especially in cases where the improved techniques were subsequently applied. Method: Fifteen resurfacing femoral components were sectioned and the slices were radiographed and photographed, and the amount and distribution of cement were examined and measured. Cases representative of the evolving cementing techniques were examined in detail. Results: There was considerable variation observed in the amount and distribution of cement, partly as a consequence of variable bone quality in this “all-comers” included series. The cement analyses showed that the newer cementing techniques helped to reduce over-penetration while providing better cement interdigitation. The use of extra fxation holes and cementing the stem in cases with poor bone quality were associated with improved cement-to-bone contact area. Conclusion: Meticulous femoral head preparation was helpful in providing durable cement fxation and is essential in cases with poor bone quality.

Quantifying Degree of Diffculty in Hip - Resurfacing of Pistol-Grip Deformity

Burton Ma, Ph.D., Stephane G. Bergeron, M.D., Heather J. Grant, M.Sc., John Rudan, M.D., and John Antoniou, M.D., Ph.D.

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This study used computer simulation to endeavor to quantify the relative degree of difficulty of resurfacing femora with pistol-grip deformities compared to relatively normal femora. Computer models of five pistol-grip femora and one relatively normal femur were computed from computed tomography (CT) scans of patients who had undergone computer-assisted hip resurfacing. A computer simulation of positioning the femoral resurfacing component on the femur was performed to count the number of acceptable configurations of the component on the femur. A high number of acceptable configurations implies that the surgeon has greater freedom, or greater margin for error, in implanting the component compared to a femur with a smaller number of acceptable configurations. We found that pistol-grip deformities dramatically reduce the number of acceptable configurations for valgus alignment, and that such configurations result in decreased femoral offset and increased depth of reaming.

Computer Navigated Hip Resurfacing for Patients with Abnormal Femoral Anatomy

Michael Olsen, B.Sc., and Emil H. Schemitsch, M.D., F.R.C.S.(C)

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Hip resurfacing is a technically demanding alternative to total hip arthroplasty. The use of traditional jigs for placement of the femoral guidewire can lead to preparatory errors that may predispose the resurfacing construct to premature failure. Computer navigation is a tool that can be used to minimize the incidence of inadequate to detrimental preparation of the femoral head and improve the accuracy of component placement. Computer navigation not only shows promise in routine cases of hip resurfacing but also in those cases that are technically challenging. The current study demonstrated the utility of imageless computer navigation in placement of the femoral component for patients presenting with abnormal femoral anatomy.

Computer-Assisted Navigation in Hip Resurfacing Arthroplasty - A Single-Surgeon Experience

John S. Shields, M.D., Thorsten M. Seyler, M.D., Cara Maguire, B.S., and Riyaz H. Jinnah, M.D.

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Hip resurfacing arthroplasty is a technically challenging procedure, and orientation of the femoral component is critical to avoid implant failure. The use of computer-assisted navigation has been shown to decrease the learning curve for beginners in hip resurfacing and to improve the surgeon’s ability to produce consistent results. Computer navigation offers real-time feedback, with the opportunity to produce improved repeatability to optimize patient outcomes. The purpose of this study was to evaluate the learning curve of computer-assisted surgery in the hands of an experienced hip resurfacing surgeon. A retrospective review of 100 consecutive navigated hip resurfacing arthroplasties in 94 patients assessed preoperative and postoperative neck-shaft angles, operative times, and complications. Twenty-fve non-navigated hip resurfacing arthroplasties, performed by the same surgeon, were evaluated as a matching group. Mean operative times for the computer-assisted hip resurfacings were 101 minutes, as compared to 104 minutes in the non-navigated group. We found that in the hands of an experienced hip resurfacing surgeon, the addition of computer-assisted navigation had no effect on the learning curve, but did provide feedback and repeatability to the surgeon.

Evaluation of Persistent Pain After Hip Resurfacing

Vassilios S. Nikolaou, M.D. Ph.D., Stephane G. Bergeron, M.D., Olga L. Huk, M.D., M.Sc., David J. Zukor, M.D., and John Antoniou, M.D., Ph.D

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Evaluation and treatment of pain following hip resurfacing arthroplasty can be challenging, even for the most experienced arthroplasty surgeon. As in any total hip replacement, there are a number of investigative tools at the disposal of orthopaedic surgeons to elicit the underlying causes of pain for diagnosis and treatment. A detailed history and physical examination are the most important frst steps in the differential diagnosis of the intrinsic and extrinsic etiologies of hip pain. Serial radiographs from the time of surgery also should be reviewed and compared for changes indicative of loosening, migration, and osteolysis, in combination or alone. Diagnostic injections with local anesthetic agents additionally can be performed to localize the origin of pain. Bone scintigraphy, hip joint aspiration, and laboratory tests, including erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), should be requested routinely to exclude an occult infection. The use of ultrasound (US), magnetic resonance imaging (MRI), and even hip arthroscopy has been suggested as potential diagnostic tools when metal sensitivity is suspected. Relative to cause, femoral neck fractures and the possibility of metal hypersensitivity as sources of persistent groin pain should always be considered in metal-on-metal hip resurfacing. Additionally, iliopsoas tendinopathy and anterior impingement of the femoral neck are well-recognized causes of pain and should be included in the differential diagnosis. Surface arthroplasty is becoming an acceptable alternative to standard total hip replacement in young patients. It is increasingly essential to recognize the different causes of pain following resurfacing in order to make an accurate diagnosis and initiate timely, appropriate treatment.

Posterior Femoroacetabular Impingement (PFAI) - After Hip Resurfacing Arthroplasty

Scott T. Ball, M.D., and Thomas P. Schmalzried, M.D.

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Introduction: The recent, encouraging outcome literature on hip resurfacing arthroplasty (HRA) has not suffciently examined the potential occurrence of postoperative femoroacetabular impingement (PFAI) and sequelae. The current study asks the questions, “Does femoroacetabular impingement occur after hip resurfacing arthroplasty (HRA) and, if so, what are the clinical outcomes?” Methods: Sixty-nine consecutive hips in 57 patients with a minimum of 2 years clinical and radiographic follow-up were evaluated. Both acetabular and femoral component positions and postsurgical changes in the femoral neck and acetabulum were recorded. Results: Fourteen hips in 13 patients (20%) developed a small scalloped, corticated erosion in the posterior neck, just distal to the femoral component and adjacent to the acetabular component rim. These erosions were between 5 and 10 mm in depth and became apparent at an average of 15 months (range, 6 to 24 months) following surgery. After 2 years, they showed no further progression. The location and shape of the erosions indicate PFAI as the etiology. One hip also demonstrated similar changes in the anterior neck. The Harris Hip Score and UCLA (University of California at Los Angeles) Activity Scores were higher in patients with such erosions (97.5 and 9.2, respectively), compared to those patients without (93.5 and 8.4, respectively). Additionally, patients with erosions reported slightly better pain relief on average than patients with no radiographic evidence of impingement. No signifcant differences in range of motion or component position were found between the two groups. Conclusions: Small, corticated, non-progressive erosions can occur from femoroacetabular impingement following HRA. The erosions were more commonly posterior in this series, and they tended to occur in active patients. There is no adverse effect on clinical outcomes, and more specifcally, there is no association of PFAI with pain.

Range of Motion After Stemmed Total Hip Arthroplasty and Hip Resurfacing - A Clinical Study

Michel J. Le Duff, M.A., Lauren E. Wisk, B.S., and Harlan C. Amstutz, M.D.

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Range of motion after total hip arthroplasty is becoming an important topic as today’s patients present at a younger age and are more active. An effective study design to carry out comparisons of clinical performance between two implants should eliminate patient-related extraneous variables (e.g., age, gender, activity level, among others). The aim of the present study was to compare the range of motion results achieved postoperatively between metalon-metal hip resurfacing (HR) and conventional total hip arthroplasty (THA) in a cohort of bilateral patients implanted with both designs. Thirty-five patients who had undergone bilateral surgery with one hip receiving an HR device and the contralateral hip receiving a THA were retrospectively selected. Sixty-nine percent of the patients were male, and at the time of implantation of the resurfacing device the mean age of the patients was 53 years. The mean follow-up time was 88 months for the hips treated with HR and 96 months for the hips that received a THA. We found no difference in any of the range of motion measurements between HR and THA even after separating the cohort into two groups based on the femoral head size of the THA (femoral heads under 40 mm and femoral heads greater or equal to 40 mm). Our investigation showed that, for most patients, prosthetic design is unlikely to be a limiting factor of range of motion after surgery provided that the positioning of the acetabular component is adequate.

Biologic Effects of Implant Debris

Nadim J. Hallab, Ph.D., and Joshua J. Jacobs, M.D.

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Biologic response to orthopedic implants debris is central to clinical performance. Eventual implant loosening due to aseptic osteolysis has been attributed to local infammatory responses to wear and corrosion products that are produced by articulating implant interfaces. The response to implant debris is dominated by local immune activation, e.g. macrophages. Immune reactivity has been shown to depend on the number of particles produced or the dose (i.e., the concentration of phagocytosable particles per tissue volume, which can be characterized by knowing the size distribution and amount of debris). Elongated particles (fbers) are generally more pro-infammatory than round particles, and there is a growing consensus that metals particles are more proinfammatory than polymers in vivo. Generally, to produce an in vitro infammatory response, particles need to be less than 10 μm, i.e. phagocytosable. However, both soluble and particulate debris derived from Co-Cr-Mo alloy implants can induce monocyte/macrophage activation and secretion of pro-infammatory cytokines such as IL-1β, TNFα, IL-6 and IL-8 via up-regulation of transcription factor NFκβ, and activation of infammasome danger signaling in human macrophages. Not only does activation of local (and systemic) infammation result in decreased osteoblast function but osteoclast activity increases. Some people are more predisposed to implant debris induced infammation and metal “allergy” testing services are becoming available. New pathways of implant debris-induced infammatory reactions continue to be discovered, such as the “danger signaling” infammasome pathway, which provides new targets for pharmaceutical intervention and improved implant performance.

The Problem with Large Diameter Metal-on-Metal Acetabular Cup Inclination

Jonathan R.T. Jeffers, Ph.D., Anne Roques, Ph.D., Andy Taylor Ph.D., and Mike A. Tuke, HNC Mech Eng

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Large diameter metal-on-metal hip bearings have proven to be clinically successful in active patients, but, in a small number, they are associated with elevated wear and high metal ion levels when cup inclination angles are too steep and the version is too extreme, or either alone. Based on the geometry of six different commercially available large diameter metal-on-metal acetabular components, this study demonstrated that the critical bearing surface operates at an angle up to 16º greater than the cup face inclination. Due to geometry alone, measured cup inclination is not the angle that most surgeons perceive it to be. We strongly recommend when employing large diameter metal-on-metal bearings that lower inclination and version angles are targeted to prevent excessive wear.

Proceedings from the NYU Hospital for Joint Diseases Clinical Research Methodology Course 2008

Methods to Analyze Real-World Databases and Registries

Hilal Maradit Kremers, M.D., M.Sc.

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Observational studies, administrative database studies, and registries offer a wealth of real-world information, if designed, maintained, and analyzed according to appropriate observational study methodology. This review summarizes basic observational study methods employed in rheumatology and highlights several notable examples. In response to growing interest in real-world effectiveness and safety data, registries are expected to proliferate in the near future. The availability of detailed clinical information in registries coupled with powerful tools for analysis offers promise for timely and accurate information on the safety and effectiveness of rheumatic treatments.

Evidence-Based Medicine and The Cochrane Collaboration

Elizabeth Tanjong-Ghogomu, M.D., M.Sc., Peter Tugwell, M.D., F.C.A.R.P., M.Sc. and Vivian Welch

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Providing evidence-based care to patients involves turning a clinical problem into an answerable question, systematically searching for the best evidence relevant to the question, critically appraising that evidence, and, fnally, using the evidence as the basis for clinical decisions to solve the problem. While the overload of medical information today presents a demanding challenge to physicians to sort and identify relevant and valid evidence, it is vitally important to translate that evidence into clinically useful terms. To apply evidence to patient clinical management, it is critical to discuss with patients the evidence, the benefts and the harms, and the alternative treatments, such that they understand and can fully participate in the decision-making process. The framework of evidenced-based medicine provides a concrete methodology to address these issues, here, framed and detailed in fve steps. The Cochrane Collaboration has been at the forefront of applying the methods of evidence-based medicine (EBM) in the treatment and management of musculoskeletal and other disorders.

Diagnostic Versus Classification Criteria - A Continuum

Hasan Yazici, M.D.

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The current understanding that disease criteria are different than classifcation criteria is not well founded. In fact, they are a continuum. The arithmetic behind the two are the same and is built on a clear understanding of the concepts of sensitivity and specifcity. Diagnosis is nothing different than classifcation in the individual patient. The main element that makes a set of criteria diagnostic is the pretest odds. We should question our current practice of making universal disease criteria and perhaps design criteria tailored to subspecialties.

Safety Reporting in Randomized Clinical Trials - A Need for Improvement

Yusuf Yazici, M.D.

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The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of “time to event,” use of standardized incidence ratios for comparison to normal population or disease controls, use of “patient years” when reporting AE, and adequate sample size and power calculations are some of the problems that need to be addressed and improved in RCTs.

RAPID3—An Index of Physical Function, Pain, and Global Status as “Vital Signs” to Improve Care for People with Chronic Rheumatic Diseases

Theodore Pincus, M.D., Martin J. Bergman, M.D., F.A.C.R., F.A.C.P., and Yusuf Yazici, M.D.

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A guide to RAPID3 (routine assessment of patient index data), an index of three patient self-report measures—physical function, pain, and patient global estimate of status—on a multidimensional health assessment questionnaire (MDAQ) is presented, including development, scoring, use in standard care, and rationale. RAPID3 and its individual components are regarded as “vital signs,” which may alert a health professional to unsuspected patient problems, provide a baseline measure to support a change in therapy, and numerically document improvement or worsening over time to complement clinical impressions. MDHAQ-RAPID3 can be incorporated into the infrastructure of standard rheumatology care for completion in the waiting room by every patient with any rheumatic disease at every visit: if there is a reason for a visit, there is a reason for RAPID3 vital signs. RAPID3 is calculated in 5 to 10 seconds, providing similar information to DAS28 (disease activity score) and CDAI (clinical disease activity index), which require a mean of 114 and 106 seconds, respectively. MDHAQ-RAPID3 presents an additional advantage for the patient to optimize the offce encounter by completion of the questionnaire in the waiting room. The MDHAQ also includes a review of systems and recent medical history, which can save 2 to 3 minutes per visit for other patient concerns. A physician’s clinical decisions ultimately require synthesis and interpretation of all available data, ranging from laboratory tests to patient questionnaire scores. RAPID3 vital signs can contribute to this synthesis toward improved quality, outcomes, and documentation of rheumatology care.

What Can We Learn from Design Faults in the Women’s Health Initiative Randomized Clinical Trial?

Orkun Tan, M.D., S. Mitchell Harman, M.D., Ph.D., and Frederick Naftolin, M.D., Ph.D.

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Design faults resulted in the inability of the Women’s Health Initiative (WHI) randomized clinical trial to test the level of cardioprotection conferred by timely hormone treatment of women seeking help for menopausal complaints. Adopting a design constructed around the avoidance of symptomatic subjects and recruitment of older subjects who were more likely to manifest cardiovascular events during the life of the WHI resulted in recruitment of older, sicker subjects than are normally treated for complaints around the time of menopause. The lack of cardioprotection in subjects that began treatment a decade or more after menopause diluted ardioprotection in subjects starting treatment close to the menopausal transition. As a result, despite having the largest number of subjects ever, there were not enough women in the WHI who were comparable to those in the observational trials that showed cardioprotection. This led the WHI to report that there was no cardioprotection in the trial, a position that has been qualifed after further analysis. Misapprehension of the initial WHI conclusions by the media, professionals, and regulatory agencies led to a major shift away from menopausal hormone treatment. This remains problematic since the evidence continues to favor cardioprotection and other benefts that are denied under present regulations and guidelines. Regulatory agencies and professional organizations need to better understand the faws in the WHI design and results in order to properly consider its results and the sustainability of their earlier conclusions and recommendations. Additionally, new trials are needed to test the validity of menopausal hormone-related cardioprotection.

Original Articles

Arthritis as a Risk Factor for Incident Coronary Heart Disease in Elderly Japanese-American Males - The Honolulu Heart Program

Mitsumasa Kishimoto, M.D., Ph.D., Jeffrey Greenberg, M.D., M.P.H., Ryan Lee, B.S., Kamal H. Masaki, M.D., Randi Chen, M.S., Beatriz L. Rodriguez, M.D., Ph.D., Patricia L. Blanchette, M.D., M.P.H., Michael H. Pillinger, M.D., and J. David Curb, M.D.

ABSTRACT
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Background: Arthritis is the most common chronic disease in the elderly. Studies show that rheumatoid arthritis is a risk factor for cardiovascular morbidity and mortality, and osteoarthritis is associated with an unfavorable cardiovascular risk factor profle. Methods: At the Honolulu Heart Program’s fourth examination in 1991 to 1993, arthritis status was assessed among a cohort of 3741 Japanese-American males, ages 71 to 93 years. Arthritis was determined by self-report of physician diagnosis, and subjects were divided into two groups: current arthritis and no current arthritis. Eight years of follow-up data are available for incident coronary heart disease (CHD) in 2777 subjects free of CHD at baseline. Age-adjusted rates of incident CHD and means of cardiovascular risk factors were compared in each group. Cox proportional hazards models were used to calculate relative risks, adjusting for common cardiovascular risk factors, alcohol, and use of aspirin or NSAIDs, or both. Results: There were 279 cases of incident CHD in the cohort over 8 years; in those with arthritis, 11.7% developed incident CHD, compared to 9.8% in those without arthritis (p = 0.24). Age-adjusted rates of incident CHD in those with and without arthritis were 20.5 and 18.0 per 1000 person-years, respectively (p = 0.25). Arthritis was not signifcantly associated with CHD risk factors. Arthritis was not a signifcant independent predictor of incident CHD (relative risk, 1.06; 95% CI, 0.74 to 1.51). Conclusions: Arthritis, and most probably osteoarthritis, may not be associated with most CHD risk factors or 8-year incident CHD in elderly Japanese-American males.

Monitoring Response to Therapy in Rheumatoid Arthritis - Perspectives from the Clinic

Patricia Daul, R.N., and Joseph Grisanti, M.D.

ABSTRACT
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The major objectives in treating patients with rheumatoid arthritis are managing the symptoms of disease and preserving joint structure, with the ultimate goal of disease remission. Several independent studies have shown that treatment decisions driven by quantitative rather than subjective monitoring of disease activity result in signifcantly improved patient outcomes. Various assessment tools are available that measure both clinical and patient-reported outcomes. While some measurement tools may be more appropriate for use in clinical trials, several have been developed that are simple and practical to use, even in a busy clinic. As pivotal members of the multidisciplinary rheumatology healthcare provider team, the nurse and the rheumatologist play key roles in managing a patient’s progress by closely monitoring their response to treatment. Here, we discuss optimal disease management founded on a multidisciplinary approach and provide an overview of some key measures for assessing patient response to treatment.

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