Christian Bitar1,2, Ferid Krupic3, Li Felländer-Tsai4,5, Sead Crnalic6, Per Wretenberg7. 1. Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden. christian.bitar@ki.se. 2. Department of Orthopedics, Karolinska University Hospital, Stockholm, Sweden. christian.bitar@ki.se. 3. Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 4. Division of Orthopedics and Biothechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden. 5. Department of Orthopedics, Karolinska University Hospital, Stockholm, Sweden. 6. Department of Surgical and Perioperative Sciences (Orthopaedics), Umeå University, Umeå, Sweden. 7. Department of Orthopaedics, School of Medical Sciences, Örebro University and Örebro University Hospital, Örebro, Sweden.
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.
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-metalhip 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-metalhip 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.
Entities:
Keywords:
Articular surface replacement; Healthcare providers; Hip resurfacing arthroplasty; Interviews; Medical device recall; Prosthesis failure; Qualitative research; Total hip replacement
Authors: Matteo Cadossi; Silvio Terrando; Andrea Sambri; Giuseppe Tedesco; Antonio Mazzotti; Barbara Bordini; Dalila De Pasquale; Cesare Faldini Journal: Musculoskelet Surg Date: 2017-04-27