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Clinical Trials/NCT05047744
NCT05047744
Unknown
Not Applicable

Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

Kepler University Hospital1 site in 1 country100 target enrollmentSeptember 15, 2019
ConditionsRhizarthrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rhizarthrosis
Sponsor
Kepler University Hospital
Enrollment
100
Locations
1
Primary Endpoint
DASH Score (Disability of Arm Shoulder and Hand Score)
Last Updated
3 years ago

Overview

Brief Summary

The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

Detailed Description

The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively). Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature. The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Registry
clinicaltrials.gov
Start Date
September 15, 2019
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kepler University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • CMC I Osteoarthritis /Stage III)

Exclusion Criteria

  • CMC I (osteoarthritis / Other Stage than III)
  • Anticoagulation

Outcomes

Primary Outcomes

DASH Score (Disability of Arm Shoulder and Hand Score)

Time Frame: 24 months

DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst

Secondary Outcomes

  • Subjective Pain(24 months)

Study Sites (1)

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