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NCT01904019 | Completed | Arthritis


Comparison of ARPE Prosthesis With the Literature
Sponsor:

Zimmer Biomet

Brief Summary:

This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.

Condition or disease

Arthritis

Detailed Description:

The primary objective is to compare functional outcome at 3 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition. Literature values obtained by a recently published meta analysis will be used. The secondary objectives are: to compare functional outcome at 1 and at 5 years after trapezio-metarcarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition to determine pre- and post-operative HR QOL Incidence of radiolucencies at each follow up time point. Literature values from the same meta analysis will be used, Patients will be assessed at preoperatively, and at 1, 3 and 5 years postoperatively. Measured Outcomes: grip strength, tip pinch strength, key pinch strength, pain, occurrence of adverse events, hand function.

Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
Actual Study Start Date : April 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : May 2021

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.
  • Inclusion Criteria
    • patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
    • patients willing to return for follow up evaluation.
    Exclusion Criteria
    • local or systemic infections
    • severe muscular, neurological or vascular deficiencies of the extremity involved
    • bone destruction or poor bone to affect implant stability
    • allergy to any of the components of the implant

  • Comparison of ARPE Prosthesis With the Literature

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    Comparison of ARPE Prosthesis With the Literature

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    Locations


    Not yet recruiting

    Belgium,

    SPM Deurne

    Deurne, Belgium, 2100

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