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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000781741

Enrollment

5000

Registered

2013-07-12

Start date

2013-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

1.Any patient with on-label use of the ASR-XL or ASR component system currently implanted. Manual addition of antibiotics to cement during arthroplasty is not considered to be off-label use. 2.Able to provide informed consent at those sites where this is required by the institution’s institutional review (IRB) or ethics committee (EC). 3.Able to return for follow-up annually for 5 years. 4.Able to complete the required patient reported outcome measures.

Exclusion criteria

1.Any patient with off-label use indications for the ASR-XL or ASR component system. 2.Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA. 3.Patients with difficulty in comprehending the Informed Consent Form for any reason. 4.The patient refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.

Outcome results