Status:
COMPLETED
Comparison of ARPE Prosthesis With the Literature
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Biomet Belgium BVBA
Conditions:
Arthritis
Eligibility:
All Genders
18+ years
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 trapez...
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. Li...
Eligibility Criteria
Inclusion
- Inclusion/exclusion criteria are identical to those indications and contraindications stated in the package insert of the implant.
- patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
- patients willing to return for follow up evaluation.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01904019
Start Date
April 1 2013
End Date
May 1 2021
Last Update
October 18 2021
Active Locations (1)
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1
SPM Deurne
Deurne, Belgium, 2100