Study of the Touch® Trapezo-metacarpal Prosthesis

Active, not recruiting

• Conditions: Complications Due to Internal Joint Prosthesis; Thumb Osteoarthritis

• Registration Number: NCT03611023
• Lead Sponsor: Groupe Concepteur Touch

Brief Summary

Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis

Detailed Description

Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29
• Primary Completion: 2036-09
• Study Completion: 2036-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Patients implanted with the Touch® prosthesis by one of the three investigating surgeons

Exclusion Criteria

• Patient not in capacity to understand the study
• Patient not in capacity to consent to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survival at 10 years	10 Years	Failure rate of the implant
Implant Survival at 3 years	3 Years	Failure rate of the implant
Implant Survival at 5 years	5 Years	Failure rate of the implant
Implant Survival at 15 years	15 Years	Failure rate of the implant

Secondary Outcome Measures

Name	Time	Method
Functional Outcome at 3 years	3 Years	QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Functional Outcome at 5 years	5 Years	QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Functional Outcome at 10 years	10 Years	QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better
Functional Outcome at 15 years	15 Years	QuickDASH score (Disabilities of the Arm, Shoulder and Hand score, is the mean result of 11 questions regarding patient ability to perform everyday activities), 0 to 100, with 0 the better

Trial Locations

Locations (1)

Hopital du Gier; 🇫🇷 Saint-Chamond, France