Revise and remember : managing hip resurfacing implant recall

Background

Total hip arthroplasty (THA) with metal-on-polyethylene articulation provides excellent clinical outcomes but remains associated with complications such as polyethylene wear and joint dislocations. For younger and more active patients, metal-on-metal (MoM) implants were initially introduced as a promising alternative. However, MoM bearings have subsequently demonstrated higher complication rates, including severe adverse events such as periprosthetic fractures and soft tissue reactions in the joint. One such implant with particularly high complication rates was the Articular Surface Replacement (ASR) by DePuy/Johnson&Johnson. As a result, the use of MoM implants declined in Sweden by 2015, and the Swedish Hip and Knee Society officially ceased recommending hip resurfacing arthroplasty in 2018. This decision started a debate in the media between pro and con groups for HRA. Adding further complexity, certain European countries have continued to perform the procedure, with follow-up challenges affecting the Swedish healthcare system. Investigating the implications of MoM implants on patients' outcomes and healthcare systems is essential for future clinical guidelines and policy decisions.

Methods

Paper I and III studied patients' experiences with the ASR hip resurfacing arthroplasty (HRA). Paper I focused on those living with the recalled implant, while Paper III examined the narratives of patients undergoing revision surgery due to complications.

Paper Il compared long-term revision rates, clinical outcomes, and changes in blood metal ion levels between patients with ASR THA and those with ASR HRA.

Paper IV investigated potential socioeconomic differences in patients receiving MoM HRA versus uncemented THA in a 1:1 matched ratio from 1999 to 2014.

Results

Patients living with asymptomatic ASR HRA implants without pain reported that they rarely thought about the implant. Many had actively sought referrals to centers performing HRA procedures. Annual hospital check-ups after surgery were highly valued by these patients, and if the patients were taken care of and informed, they continued to express their trust in the healthcare system.

Among patients who underwent revision surgery, some were satisfied with their new implants, while others continued to experience pain and further complications. Despite the recall, since the patients were well taken care of, trust in the healthcare system remained intact.

In a cohort of 38 patients, 11-year outcomes revealed no revisions among ASR HRA recipients, but 32% of ASR XL THA recipients required revision surgery. The ASR XL THA group also exhibited significantly elevated cobalt ion levels, even in well-functioning implants.

Patients with lower education and income levels were more likely to receive uncemented THA than MoM HRA.

Conclusion

When an implant is recalled due to high complication rates, robust support systems, including annual follow-ups, are crucial. Patients emphasized the importance of transparent communication regarding implant risks. ASR XL THA demonstrated poorer outcomes compared to ASR HRA, with rising cobalt ion levels in asymptomatic patients, necessitating regular monitoring. Socioeconomic differences in implant selection challenge the principle of equitable healthcare, warranting further attention.

List of scientific papers

I. Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty. Bitar C, Krupic F, Felländer-Tsai L, Crnalic S, Wretenberg P. Patient Saf Surg. 2021;15(1):2. https://doi.org/10.1186/s13037-020-00278-y

II. 11-Year outcomes in patients with metal-on-metal ASR hip arthroplasty. Bitar C, Moberg I, Krupic F, Wretenberg P, Otten V, Crnalic S. J Orthop. 2022;32:98-103. https://doi.org/10.1016/j.jor.2022.05.015

III. Beyond the procedure of a recalled implant: Patients' experiences of ASR hip implant revision. Bitar C, Wretenberg P, Felländer-Tsai L, Crnalic S, Krupic F. [Submitted]

IV. Socioeconomic disparities in the utilization of metal-on-metal hip resurfacing compared to uncemented total hip arthroplasty: A population-based case-control study in Sweden. Oxblom A, Bitar C, Rolfson O, Hedlund H, Qureshi AR, Brismar H, Wretenberg P, Palme M, Adami J, and Felländer-Tsai L. [Submitted]