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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05047744
Other study ID # KUK-UNF-21-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source Kepler University Hospital
Contact Stefan M Froschauer, MD
Phone 004373278061020
Email stefan.froschauer@kepleruniklinikum.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - CMC I Osteoarthritis /Stage III) Exclusion Criteria: - CMC I (osteoarthritis / Other Stage than III) - Anticoagulation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Touch Dual Mobility CMC I Prosthesis
Surgery

Locations

Country Name City State
Austria Kepler Universitaetsklinikum GmbH Linz

Sponsors (1)

Lead Sponsor Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary DASH Score (Disability of Arm Shoulder and Hand Score) 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 24 months
Secondary Subjective Pain patients report about subjective Pain level in average at 6, 12 and 24 months in a VAS (Visual Analog Pain Scale) scale (0-10), whereas 0 is best and 10 worst 24 months
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