Hypersensitivity to metals in metal-on-metal hip arthroplasty: a prospective study of one hundred and thirty five lymphocyte transformation tests.

Background: Metal allergy remains a controversial topic in the orthopaedic community. It is not known if or to what degree metal sensitivity contributes to inflammatory soft tissue failures, unexplained residual pain, or clinical complications after total joint replacement with metal prostheses.

Methods: We investigated the efficacy of the lymphocyte transformation test (LTT) in predicting adverse outcomes in patients after receiving a metal joint replacement.

Long-term clinical outcomes of the Biomet M2a-38: a retrospective review of 335 total hip arthroplasty cases.

Background: At the turn of the century, over one-third of total hip arthroplasties comprised metal-on-metal bearings. As this patient population and their implants age, it is crucial to understand associated late failure modes and expected long-term functional outcomes. We report the long-term results of a large metal-on-metal uncemented total hip arthroplasty system with unique design characteristics compared to others that have been reported with high failure rates.

Antibiotic Delivery via Hickman Catheter for the Treatment of Prosthetic Joint Infection.

Infection rates for total joint arthroplasty range from 1% to 2%, and infection carries significant risk. The traditional course of treatment is irrigation and debridement, but historically, success rates have been variable. The goals of this study were to evaluate the safety and efficacy of Hickman catheterization in the treatment of prosthetic joint infection and to assess its value as an alternative to irrigation and debridement.

Optimizing Acetabular Component Bone Ingrowth: The Wedge-Fit Bone Preparation Method.

We investigate the efficacy of a modified acetabular bone-preparation technique in reducing the incidence of two clinical problems identified in hip resurfacing arthroplasty. The first issue is failure due to lack of bone ingrowth into the acetabular component. The second is a newly recognized phenomenon of early cup shift.

Femoral Fixation Methods in Hip Resurfacing Arthroplasty: An 11-Year Retrospective Comparison of 4013 Cases.

Background: The optimal femoral fixation method remains unclear. To evaluate the role of femoral fixation techniques in hip resurfacing, we present a comparison of 2 consecutive groups: group 1 (739 hips) with cemented femoral components; group 2 (3274 hips) with uncemented femoral components.

Methods: We retrospectively analyzed our clinical database to compare failures, reoperations, complications, clinical results, and radiographic measurements.

Hip resurfacing arthroplasty for end-stage arthritis caused by childhood hip disease.

Introduction: Patients with hip arthritis due to Legg-Calvé-Perthes (LCP) and slipped capital femoral epiphysis (SCFE) pose altered femoral anatomy, making hip resurfacing arthroplasty (HRA) technically complicated. We examined implant survival and clinical symptoms in patients with a history of LCP or SCPE who underwent HRA for end-stage osteoarthritis.

Methods: Data was collected for patients who underwent HRA for osteoarthritis due to LCP ( 59) or SCFE ( 32).

Acetabular Debonding: An Investigation of Porous Coating Delamination in Hip Resurfacing Arthroplasty.

Background: To date, there have been no published investigations on the cause of acetabular debonding, a rare failure phenomenon in metal-on-metal hip resurfacing where the acetabular porous coating delaminates from the implant while remaining well fixed to the pelvic bone.

Purposes: This study aims to summarize the current understanding of acetabular debonding and to investigate the discrepancy in rate of debonding between two implant systems.

Patients And Methods: To elucidate potential causes of debonding, we retrospectively analyzed a single-surgeon cohort of 839 hip resurfacing cases.

Interventions for Improving Hip Resurfacing Outcomes in Women: A High-Volume, Retrospective Study.

Background: Women seeking surgical intervention for their hip disorders will often find total hip arthroplasty (THA) presented as their only option. THA, when compared with hip resurfacing arthroplasty, removes substantially more bone-stock, limits range-of-motion, exhibits increased dislocation risk, and presents greater overall 10-year mortality rate. Despite these risks, most surgeons continue to select against women for hip resurfacing because registries notoriously report inferior survivorship when compared with men and THA.

Metal-on-metal hip resurfacing in patients younger than 50 years: a retrospective analysis : 1285 cases, 12-year survivorship.

Background: The Nordic registry reports patients under 50 years old with total hip replacements realize only 83% 10-year implant survivorship. These results do not meet the 95% 10-year survivorship guideline posed by the UK's National Institute for Health and Care Excellence (NICE) in 2014.

Methods: The purpose of this study is threefold: First, we evaluate if metal-on-metal hip resurfacing arthroplasty meets these high standards in younger patients.

Comparison of Cemented and Bone Ingrowth Fixation Methods in Hip Resurfacing for Osteonecrosis.

Background: The optimal surgical treatment for osteonecrosis of the femoral head has yet to be elucidated. To evaluate the role of femoral fixation techniques in hip resurfacing, we present a comparison of the results for 2 consecutive groups: group 1 (75 hips) received hybrid hip resurfacing implants with a cemented femoral component; group 2 (103 hips) received uncemented femoral components. Both groups received uncemented acetabular components.

Reducing the failure rate of hip resurfacing in dysplasia patients: a retrospective analysis of 363 cases.

Background: Arthritis secondary to developmental hip dysplasia often mandates implant surgery at a relatively young age. Hip resurfacing arthroplasty (HRA), compared with standard stemmed total hip arthroplasty (THA), affords a more active lifestyle including extreme-motion activities but stimulates concerns pertaining to implant failure.

Methods: We addressed the primary modes of failure through a series of interventions, including a new guideline for achieving proper implant alignment through intraoperative x-rays.

Outcomes after revision of metal-on-metal hip resurfacing arthroplasty.

We report the results of 58 hip resurfacing arthroplasties (HRA) revised by a single surgeon with an average of 5.2±2.6 years follow-up.

Incidence of adverse wear reactions in hip resurfacing arthroplasty: a single surgeon series of 2,600 cases.

A single surgeon performed 2,559 metal-on-metal hip resurfacing arthroplasties in 
2,109 patients. The Corin Cormet 2000 (393 cases) and Biomet Recap implants (2,166 cases) were used in our series. In this study, the adverse wear failure (AWF) rate was 0.

Current status of modern fully porous coated metal-on-metal hip resurfacing arthroplasty.

Between March 2007 and July 2010, 1000 consecutive fully porous coated hip resurfacing arthroplasties (HRA) were performed by a single surgeon in 871 patients. The average length of follow-up was 3 ± 1 years. Three cases (0.

A safe zone for acetabular component position in metal-on-metal hip resurfacing arthroplasty: winner of the 2012 HAP PAUL award.

A safe zone for acetabular component positioning in hip resurfacing (RAIL: Relative Acetabular Inclination Limit) was calculated based on implant size and acetabular inclination angle (AIA). For AIA below the RAIL, there were no adverse wear failures or dislocations, and only 1% of cases with ion levels above 10 μg/L. Other than high inclination angle and small bearing size, female gender was the only other factor that correlated with high ion levels in the multivariate analysis.

Feasibility of proactive medical device surveillance: the VA Clinical Assessment Reporting and Tracking (CART) program.

Background: Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs to maximize patient safety. Cardiac catheterization laboratories are high-device utilization areas well suited for device surveillance.

Objective: To demonstrate the feasibility of the national VA Clinical Assessment, Reporting, and Tracking (CART) system, embedded in the electronic health record of all 76 VA cardiac catheterization laboratories, to document unexpected problems with medical devices at the point of care.

Sex and risk of hip implant failure: assessing total hip arthroplasty outcomes in the United States.

Importance: The role of sex in relationship to implant failure after total hip arthroplasty (THA) is important for patient management and device innovation.

Objective: To evaluate the association of sex with short-term risk of THA revision after adjusting for patient, implant, surgery, surgeon, and hospital confounders.

Design And Setting: A prospective cohort of patients enrolled in a total joint replacement registry from April 1, 2001, through December 31, 2010.

Comparative study between patients with osteonecrosis and osteoarthritis after hip resurfacing arthroplasty.

The purpose of this study was to compare the clinical outcomes of osteonecrosis (ON) and osteoarthritis (OA) patients after metal-on-metal hip resurfacing arthroplasty (HRA). We retrospectively reviewed our database and identified a study group of 122 HRA cases with the primary diagnosis of ON. A control group of 122 OA cases were randomly selected by a computer program to match the surgical date, gender and the femoral component type and size with the study group.

Total knee arthroplasty with fully porous-coated stems for the treatment of large bone defects.

Between February1999 and April 2006, 25 patients (28 knees) underwent a TKA by a single surgeon. At an average final follow-up of 7±2years (range, 3-10years), 34 (100%) of 34 fully porous stems had achieved bone ingrowth. However, one case (3%) had a component loosening due to the de-bonding of sheets of beads from the stem.

Risk of revision for fixed versus mobile-bearing primary total knee replacements.

Background: Mobile-bearing total knee arthroplasty prostheses were developed to reduce wear and revision rates; however, these benefits remain unproven. The purposes of this study were to compare the short-term survivorship and to determine risk factors for revision of mobile-bearing and fixed-bearing total knee replacements.

Methods: A prospective cohort study of primary total knee arthroplasties performed from 2001 to 2009 was conducted with use of a community total joint replacement registry.

FDA working to ensure the safety of medical devices used in the pediatric population.

Special initiatives exist in FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research to ensure the safety and effectiveness of medical products used in the vulnerable pediatric population. This article focuses on the special programs, projects, and special studies implemented by CDRH to ensure this safety and effectiveness in devices used in pediatric patients throughout the devices' total product life-cycles. Pediatricians play a major role in keeping medical devices safe for use in children by reporting device problems to FDA.

Long-term outcomes after transmyocardial revascularization.

Background: Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices.

Methods: The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386).

Hip resurfacing with the Biomet Hybrid ReCap-Magnum system: 7-year results.

The purpose of this study was to report our clinical outcome of a large series of metal-on-metal hip resurfacing arthroplasty (HRA) using the hybrid Biomet ReCap-Magnum system. This is a single-designer surgeon series with an average of 5 ± 1 years. Seven hundred forty consecutive hybrid HRAs were performed in 653 patients.