RecruitingACTRN12613000781741

A Post Recall Clinical Follow-up of patients previously treated with the DePuy Articular Surface Replacement Hip System.

Clinical Follow-up of ASR patients Post -Recall A 5 year Post Recall Clinical Follow-up study to collect longitudinal data from patients previously treated with the DePuy Articular Surface Replacement Hip System

Sponsor

Massachusetts General Hospital

Enrollment

5,000 participants

Start Date

May 1, 2013

Study Type

Observational

Conditions

Clinical outcomes post hip replacement

Summary

Aims of the project The aims of this research project are to: Collect information to monitor the health and progress of in study participants who have been treated with either the Depuy ASR Trademark XL Acetabular Hip System or DePuy ASR Trademark Hip Resurfacing Systems. This is a global research project, coordinated by Massachusetts General Hospital (MGH), Boston Massachusetts USA, to be conducted at multiple sites worldwide. The International Musculoskeletal Research Institute Inc. (IMRI) is the contracted research Organisation to conduct this study in Australia at number of sites including the site of SPORTSMED SA. MGH has a contract with Depuy Orthopaedics to undertake the study as a global research project

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is following up patients who previously received a specific hip implant system called the DePuy ASR (Articular Surface Replacement), which was recalled due to high failure rates and concerns about metal debris causing tissue damage. Researchers are collecting health and outcome data from these patients over 5 years to monitor how their hips are performing and detect any complications related to the implant. You may be eligible if: - You currently have a DePuy ASR XL Acetabular or ASR Hip Resurfacing implant in place (used as intended) - You are able to give informed consent - You are able to return for annual follow-up visits for 5 years - You can complete patient-reported outcome questionnaires You may NOT be eligible if: - Your DePuy ASR implant was used in an off-label way - You received the implant as a revision or conversion procedure - You have difficulty understanding the consent form - You refuse to allow your medical records to be reviewed by the study sponsor Talk to your doctor about whether this trial might be right for you.

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Interventions

For 5 years post hip replacement, each study participant will be observed and monitored for the rate of revision, adverse events/complications (local tissue reaction and metal ion levels in serum or

For 5 years post hip replacement, each study participant will be observed and monitored for the rate of revision, adverse events/complications (local tissue reaction and metal ion levels in serum or whole blood) and patient reported outcome measures (PROMs), to determine potential predictors for these outcomes. A web-based data entry system managed will collect data from multiple sites internationally to document the radiographic and clinical outcomes of the DePuy Articular Surface Replacement Hip systems. All enrolled patients will be monitored with annual clinical exams and serum or whole blood levels of cobalt and chromium. All data will be uploaded to the central database when the exams are performed.

Locations(1)

Sportsmed SA Hospital - Stepney

NSW,SA,VIC, Australia

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ACTRN12613000781741