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NCT02244788 Clinical Trial

Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Arthroplasty of the PIP Joint Clinical Trial

Official title:
Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT02244788
Other study ID # 2013-059
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date April 2024
Source Hospital for Special Surgery, New York
Contact Christian Victoria
Phone 646-714-6640
Email victoriac@hss.edu
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• SR™ PIP

Locations
Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)
Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States,