Clinical trial NCT01904019: Comparison of ARPE Prosthesis With the Literature
Official title: Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Keywords: arthroplasty
trapezio-metacarpial
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet Belgium BVBA
First posted: 2013-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.

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 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.

Eligibility 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

Primary outcomes:
measure: Grip Strength
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Key Pinch Strength
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Tip Pinch Strength
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: VAS Pain
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
Secondary outcomes:
measure: Motion - ROM Measurement - Radial Abduction
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Motion - ROM Measurement - Palmar Abduction
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: EQ-5D - Health Status Score
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: EQ-5D - VAS Score
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis
timeFrame: 1, 3 and 5 years follow-up
measure: Hand Function: DASH Questionnaire - Disability
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Hand Function: DASH Questionnaire - Work
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
measure: Hand Function: DASH Questionnaire - Sport
timeFrame: Pre-operative, 1, 3 and 5 years follow-up
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: SPM Deurne
Study officials:
affiliation: SPM Deurne
name: Frederik VERSTREKEN, PhD
role: PRINCIPAL_INVESTIGATOR
References: