NCT02434913

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.)

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

First QC Date

September 15, 2014

Last Update Submit

February 20, 2018

Conditions

Keywords

Proximal interphalangeal joint deformityArthroplasty

Interventions

HUD for use in arthroplasty of the PIP joint

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with disability of the their finger from arthrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Timothy Allen, MD

    Steadman Hawkins Clinic of the Carolinas - Greenville Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

May 6, 2015

Last Updated

February 22, 2018

Record last verified: 2018-02