Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

• Conditions: Arthroplasty of the MCP Joint

• Registration Number: NCT02244775
• 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™ MCP (Metacarpophalangeal) 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™ MCP (Metacarpophalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ MCP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed MCP 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 MCP joint.

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

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

Inclusion Criteria

• patient is in need of a revision of failed MCP 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 MCP joint

Exclusion Criteria

• patient is not in need of a revision of a failed MCP 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