Comparison of ARPE Prosthesis With the Literature

Zimmer Biomet

Status: Completed

Conditions: Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01904019

ORTHO.CR.E16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design