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Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Available
CT.gov ID
NCT02244788
Collaborator
(none)
1
Location

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: SR™ PIP

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 Design

Study Type:
Expanded Access
Official Title:
Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital for Special Surgery New York New York United States 10021

    Sponsors and Collaborators

    • Hospital for Special Surgery, New York

    Investigators

    • Principal Investigator: Edward Athanasian, MD, Hospital for Special Surgery, New York

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT02244788
    Other Study ID Numbers:
    • 2013-059
    First Posted:
    Sep 19, 2014
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of Apr 11, 2022