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

Journal JAMA Internal Medicine
Authors Inacio, Maria CS; Ake, Christopher F.; Paxton, Elizabeth W.; Khatod, Monti; Wang, Cunlin; Gross, Thomas P.; Kaczmarek, Ronald G.; Marinac-Dabic, Danica; Sedrakyan, Art
Year Published 2014
Link to Publication

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.

PARTICIPANTS:

Patients undergoing primary, elective, unilateral THA.

MAIN OUTCOME MEASURES:

Failure of THA, defined as revision procedure for (1) any reason, (2) septic reason, or (3) aseptic reason after the index procedure.

RESULTS:

A total of 35,140 THAs with 3.0 years of median follow-up were identified. Women constituted 57.5% of the study sample, and the mean (SD) patient age was 65.7 (11.6) years. A higher proportion of women received 28-mm femoral heads (28.2% vs 13.1%) and had metal on highly cross-linked polyethylene-bearing surfaces (60.6% vs 53.7%) than men. Men had a higher proportion of 36-mm or larger heads (55.4% vs 32.8%) and metal on metal-bearing surfaces (19.4% vs 9.6%). At 5-year follow-up, implant survival was 97.4% (95% CI, 97.2%-97.6%). Device survival for men (97.7%; 95% CI, 97.4%-98.0%) vs women (97.1%; 95% CI, 96.8%-97.4%) was significantly different (P = .01). After adjustments, the hazards ratios for women were 1.29 (95% CI, 1.11-1.51) for all-cause revision, 1.32 (95% CI, 1.10-1.58) for aseptic revision, and 1.17 (95% CI, 0.81-1.68) for septic revision.

CONCLUSIONS:

After considering patient-, surgery-, surgeon-, volume-, and implant-specific risk factors, women had a 29% higher risk of implant failure than men after THA in this community-based sample.

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Beyond joint implant registries: a patient-centered research consortium for comparative effectiveness in total joint replacement.

Journal JAMA
Authors Franklin, Patricia; Allison, Jeroan; Ayers, David
Year Published  2012
Link to Website

Introduction

Despite the proven effectiveness of total joint replacement (TJR) surgery in relieving advanced knee and hip arthritis pain, TJR outcomes have come under intense public scrutiny in recent years. The 2010 recall of ASR metal-on-metal hip implants1 heightened awareness of the importance for implant safety surveillance for this high-cost and high-use procedure and exposed the need for a national systematic patient-centered outcomes monitoring system. These safety concerns and the exponential growth in TJR use—given the demographics of the baby boomer generation—emphasize the need for systematic comparative effectiveness research (CER) to inform patients, physicians, and policy makers about the optimal practices in TJR surgery.

Comparative evidence assessment of implantable hip devices by bearing surface: systematic appraisal of evidence

Journal British Medical Journal
Authors Sedrakyan A; Normand S-L; Dabic S; Jacobs S; Graves S; Marinac-Dabic D
Year Published 2011
Link to Publication

Objective

To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants.

Design

Systematic review of clinical trials, observational studies, and registries.

Data sources

Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration.

Study selection

Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed.

Results

There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding.

Conclusions

There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.