NCT01904019

Comparison of ARPE Prosthesis With the Literature

Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Arthritis

Timeline

• Start date: 2013-04-01
• Primary completion: 2020-10-01
• Completion: 2021-05-01
• First posted: 2013-07-19
• Last updated: 2021-10-18
• Results posted: 2021-08-23

Locations

1 site across 1 country: Belgium