Dataset Information

Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty.

ABSTRACT:

Background

Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients' own experiences living with an implant that they knew had a high complication rate and had been recalled from the market.

Methods

A total of 14 patients, still living with the implant, of a cohort of 34 patients were available for follow-up. Qualitative semi-structured interviews were conducted with 14 patients where a majority actively sought for metal-on-metal hip resurfacing arthroplasty (HRA), and subsequently underwent HRA with an ASR prosthesis between 11/21/2006 and 09/28/2009. The responses were analyzed using content analysis described by Graneheim and Lundman to compress text and identify categories and subcategories.

Results

The results showed that most patients had already decided that they wanted a metal-on-metal HRA implant before meeting the surgeon. They expressed that the implant made it possible to live an active life. A majority did not think about the fact that they had a hip implant, because they lacked subjective pain. Most of the patients were positive about the annual exams at the hospital and wanted them to continue. None of them felt that their trust towards the healthcare system had changed after the implant recall. They expressed a belief that they would need new surgery sooner than they first thought.

Conclusions

Despite all the attention when the ASR prosthesis was recalled, patients with ASR-HRA did not report themselves negatively affected by the recall in this group of patients where a majority had actively sought for an HRA procedure. The healthcare system has an obligation to continue the annual exams, even if the implant provider does not continue reimbursement.

SUBMITTER: Bitar C

PROVIDER: S-EPMC7788783 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty.

Bitar Christian C Krupic Ferid F Felländer-Tsai Li L Crnalic Sead S Wretenberg Per P

Patient safety in surgery 20210106 1

<h4>Background</h4>Total hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients' own experiences living with a ...[more]

PMID: 33407687

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Project description:BackgroundFemoroacetabular impingement and degenerative hip osteoarthritis (OA) affect athletes across a wide variety of sports. Hip resurfacing arthroplasty (HRA) has emerged as a surgical treatment for active individuals with end-stage hip OA to provide pain relief and allow return to high-impact activities. Return to professional sports after HRA has not been well characterized.Purpose/hypothesisThe aim of this study was to report on a series of elite athletes in a variety of sports who underwent HRA. We hypothesized that professional and elite-level athletes would be able to return to sports after HRA for end-stage hip OA.Study designCase series; Level of evidence, 4.MethodsA retrospective case series was conducted on professional athletes who underwent HRA at a single institution between 2007 and 2017. All surgeries were performed by a single surgeon using the posterolateral approach. Athletes' return to play and sport-specific performance statistics were obtained using self-reported and publicly available data sources. Athletes were matched to an age- and performance-based cohort to determine changes in performance-based metrics.ResultsEight professional athletes were identified, including 2 baseball pitchers, 1 ice hockey defenseman, 1 foil fencer, 1 men's doubles tennis player, 1 basketball player, 1 ultramarathoner, and 1 Ironman triathlete. All 8 patients returned to sports; 6 of 8 (75%) patients were able to return for at least 1 full season at a professional level after surgery. There were no significant differences between performance statistics for athletes who returned to play and their preoperative performance measures for the years leading up to surgery or the age- and performance-matched cohort.ConclusionHRA remains a surgical alternative for end-stage hip OA in young, high-impact, active patients. While the primary goals of surgery are pain control and quality of life improvement, it is possible to return to elite-level sporting activity after HRA.

Project description:BACKGROUND:Metal-on-metal hip resurfacing was developed for younger, active patients as an alternative to THA, but it remains controversial. Study heterogeneity, inconsistent outcome definitions, and unstandardized outcome measures challenge our ability to compare arthroplasty outcomes studies. QUESTIONS/PURPOSES:We asked how early revisions or reoperations (within 5 years of surgery) and overall revisions, adverse events, and postoperative component malalignment compare among studies of metal-on-metal hip resurfacing with THA among patients with hip osteoarthritis. Secondarily, we compared the revision frequency identified in the systematic review with revisions reported in four major joint replacement registries. METHODS:We conducted a systematic review of English language studies published after 1996. Adverse events of interest included rates of early failure, time to revision, revision, reoperation, dislocation, infection/sepsis, femoral neck fracture, mortality, and postoperative component alignment. Revision rates were compared with those from four national joint replacement registries. Results were reported as adverse event rates per 1000 person-years stratified by device market status (in use and discontinued). Comparisons between event rates of metal-on-metal hip resurfacing and THA are made using a quasilikelihood generalized linear model. We identified 7421 abstracts, screened and reviewed 384 full-text articles, and included 236. The most common study designs were prospective cohort studies (46.6%; n = 110) and retrospective studies (36%; n = 85). Few randomized controlled trials were included (7.2%; n = 17). RESULTS:The average time to revision was 3.0 years for metal-on-metal hip resurfacing (95% CI, 2.95-3.1) versus 7.8 for THA (95% CI, 7.2-8.3). For all devices, revisions and reoperations were more frequent with metal-on-metal hip resurfacing than THA based on point estimates and CIs: 10.7 (95% CI, 10.1-11.3) versus 7.1 (95% CI, 6.7-7.6; p = 0.068), and 7.9 (95% CI, 5.4-11.3) versus 1.8 (95% CI, 1.3-2.2; p = 0.084) per 1000 person-years, respectively. This difference was consistent with three of four national joint replacement registries, but overall national joint replacement registries revision rates were lower than those reported in the literature. Dislocations were more frequent with THA than metal-on-metal hip resurfacing: 4.4 (95% CI, 4.2-4.6) versus 0.9 (95% CI, 0.6-1.2; p = 0.008) per 1000 person-years, respectively. Adverse event rates change when discontinued devices were included. CONCLUSIONS:Revisions and reoperations are more frequent and occur earlier with metal-on-metal hip resurfacing, except when discontinued devices are removed from the analyses. Results from the literature may be misleading without consistent definitions, standardized outcome metrics, and accounting for device market status. This is important when clinicians are assessing and communicating patient risk and when selecting which device is most appropriate for individual patients.

Project description:BACKGROUND: Modern metal-on-metal hip resurfacing was introduced as a bone-preserving method of joint reconstruction for young and active patients; however, the large diameter of the bearing surfaces is of concern for potentially increased metal ion release. PATIENTS AND METHODS: 71 patients (< 65 years old) were randomly assigned to receive either a resurfacing (R) hip arthroplasty (n = 38) or a conventional metal-on-metal (C) hip arthroplasty (n = 33). Functional outcomes were assessed preoperatively and at 6, 12, and 24 months. Cobalt and chromium blood levels were analyzed preoperatively and at 3, 6, 12, and 24 months. RESULTS: All functional outcome scores improved for both groups. At 12 and 24 months, the median UCLA activity score was 8 in the R patients and 7 in the C patients (p < 0.05). At 24 months, OHS was median 16 in C patients and 13 in R patients (p < 0.05). However, in spite of randomization, UCLA scores also appeared to be higher in R patients at baseline. Satisfaction was similar in both groups at 24 months. Cobalt concentrations were statistically significantly higher for R patients only at 3 and 6 months. Chromium levels remained significantly higher for R patients until 24 months. No pseudotumors were encountered in either group. One R patient was revised for early aseptic loosening and in 2 C patients a cup insert was exchanged for recurrent dislocation. INTERPRETATION: R patients scored higher on UCLA, OHS, and satisfaction at some time points; however, as for the UCLA, preoperative levels were already in favor of R. The differences, although statistically significant, were of minor clinical importance. Chromium blood levels were statistically significantly higher for R patients at all follow-up measurements, whereas for cobalt this was only observed up to 6 months. The true value of resurfacing hip arthroplasty over conventional metal-on-metal hip arthroplasty will be determined by longer follow-up and a possible shift of balance between their respective (dis)advantages.

Project description:Background and purpose - Gait analysis performed under increased physical demand may detect differences in gait between total (THA) versus resurfacing hip arthroplasty (RHA), which are not measured at normal walking speed. We hypothesized that patients after RHA would reach higher walking speeds and inclines compared with THA. Additionally, an RHA would enable a more natural gait when comparing the operated with the healthy contralateral hip. Patients and methods - From a randomized controlled trial comparing THA with RHA with at least 5 years' follow-up patients with a UCLA score of more than 3 points (n = 34) were included for an instrumented treadmill gait analysis. 25 patients with a unilateral implant (primary analysis-16 THA versus 9 RHA) and 9 patients with a bilateral implant (sub-analysis-n = 5 RHA + THA; n = 4 THA + THA). Spatiotemporal parameters, ground reaction forces, and range of motion were recorded at increasing walking speeds and inclines. Functional outcome scores were obtained. Results - At a normal walking speed of 1.1 m/s and at increasing inclines no differences were recorded in gait between the 2 groups with a unilateral hip implant. With increasing walking speed the RHA group reached a higher top walking speed (TWS) (adjusted difference 0.07 m/s, 95% CI -0.11 to 0.25) compared with THA. Additionally, RHA patients tolerated more weight on the operated side at TWS (155 N, CI 49-261) and as such weight-bearing approached the unaffected contralateral side. For the RHA group a "between leg difference" of 8 N (CI 3-245) was measured versus -129 N (CI -138 to -29) for THA (adjusted difference 144 N, CI 20-261). Hip flexion of the operated side at TWS was higher after RHA compared with THA (adjusted difference 8°, CI 1.7-14). Interpretation - In this study RHA patients reached a higher walking speed, and preserved a more normal weight acceptance and a greater range of hip flexion against their contralateral healthy leg as compared with patients with a THA.

Dataset Information

Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty.

Background

Methods

Results

Conclusions

Publications

Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty.

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