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HUD: PIP Joint Implant

Primary Purpose

Arthrosis, Osteoarthrosis

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
SR PIP Implant System
Sponsored by
The Hawkins Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Arthrosis focused on measuring Proximal interphalangeal joint deformity, Arthroplasty

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients with disability of the their finger from arthrosis

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2014
    Last Updated
    February 20, 2018
    Sponsor
    The Hawkins Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02434913
    Brief Title
    HUD: PIP Joint Implant
    Official Title
    HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hawkins Foundation

    4. Oversight

    5. 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.)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthrosis, Osteoarthrosis
    Keywords
    Proximal interphalangeal joint deformity, Arthroplasty

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    SR PIP Implant System
    Intervention Description
    HUD for use in arthroplasty of the PIP joint

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Eligibility Criteria
    Inclusion Criteria: Patients with disability of the their finger from arthrosis Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy Allen, MD
    Organizational Affiliation
    Steadman Hawkins Clinic of the Carolinas - Greenville Health System
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    HUD: PIP Joint Implant

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