Comparison of ARPE Prosthesis With the Literature

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Arthritis

Clinical Trial Details

NCT number	NCT01904019
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	April 2013
Completion date	May 2021

View Details

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