Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

• Conditions: Arthroplasty of the PIP Joint

• Registration Number: NCT02244788
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device

Detailed Description

The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed PIP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint.

Study Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patient is in need of a revision of failed PIP prosthesis(es)
• patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint

Exclusion Criteria

• patient is not in need of a revision of a failed PIP prothesis(es)
• patient is eligible to use an alternative implant

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States