Overview

This trial is active, not recruiting.

Condition arthritis
Sponsor Biomet, Inc.
Collaborator Biomet Belgium BVBA
Start date April 2013
End date April 2018
Trial size 100 participants
Trial identifier NCT01904019, ORTHO.CR.E16

Summary

Comparison of functional outcome at 3 years after trapezio-metacarpal arthroplasty with trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Functional outcome
time frame: 3 years follow-up

Secondary Outcomes

Measure
pain
time frame: 5 years follow-up
hand function
time frame: 5 years follow-up
Motion
time frame: 5 years follow-up
Quality of life
time frame: 5 years follow-up
Radiographic assessment
time frame: 5 years follow-up
adverse event
time frame: as requested

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis : Stage II - IV - 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

Additional Information

Official title Trapezia-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature
Principal investigator Frederik VERSTREKEN, PhD
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 analysis1 will be used. 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 postop HR QOL - Incidence of RLL at each follow up time point. Literature values from the same meta analysis1 will be used.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..