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Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

NCT05267964 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-07

No results posted yet for this study

Summary

Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)

Conditions

  • Arthropathy of Hand

Interventions

PROCEDURE

Epping resection arthroplasty

Follwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.

PROCEDURE

CMC I prosthesis

Follwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.

Sponsors & Collaborators

  • Stryker Instruments

    collaborator INDUSTRY

  • Medical University of Graz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-01
Primary Completion
2019-11-30
Completion
2022-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267964 on ClinicalTrials.gov