HUD: PIP Joint Implant

Sponsor
The Hawkins Foundation (Other)
Overall Status
No longer available
CT.gov ID
NCT02434913
Collaborator
(none)

Study Details

Study Description

Brief Summary

This surgery involves the use of a finger joint replacement device for treatment of patients with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who expect to place their hands in heavy loading situations, or patients needing revision of a failed implant placed in the PIP joint. A joint replacement surgery is an operation where the arthritic joint is removed and a metal and plastic joint is inserted to replace the natural joint. The surgery is expected to last about 2 hours. The procedure is done in the operating room and requires general anesthesia or an axillary block. (General anesthesia affects the entire body and is accompanied by a loss of consciousness. An axillary block results in anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent bleeding during the surgery.)

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

Study Design

Study Type:
Expanded Access
Official Title:
HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients with disability of the their finger from arthrosis
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The Hawkins Foundation

    Investigators

    • Principal Investigator: Timothy Allen, MD, Steadman Hawkins Clinic of the Carolinas - Greenville Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Hawkins Foundation
    ClinicalTrials.gov Identifier:
    NCT02434913
    Other Study ID Numbers:
    • Pro00026976
    First Posted:
    May 6, 2015
    Last Update Posted:
    Feb 22, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by The Hawkins Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 22, 2018