Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Hospital for Special Surgery (HSS)

Status

Conditions: Arthroplasty of the PIP Joint

Treatments: Device: SR™ PIP

Study type: Expanded Access

Funder types: Other

Identifiers

NCT02244788

2013-059

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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