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

Not Applicable

Recruiting

• Conditions: Clinical outcomes post hip replacement; Musculoskeletal - Normal musculoskeletal and cartilage development and function

• Registration Number: ACTRN12613000781741
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified