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

Rhizarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047744
• Other study ID #: KUK-UNF-21-001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

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