Study of the Touch® Trapezo-metacarpal Prosthesis

Thumb Osteoarthritis Clinical Trial

Official title:

Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03611023
• Other study ID #: 2018-01
• Status: Active, not recruiting
• Start date: October 1, 2018
• Est. completion date: September 2036

Study information

• Verified date: November 2019
• Source: Groupe Concepteur Touch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: September 2036
• Est. primary completion date: September 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Complications Due to Internal Joint Prosthesis
• Osteoarthritis
• Thumb Osteoarthritis

Locations

Country	Name	City	State
France	Hopital du Gier	Saint-Chamond

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Concepteur Touch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survival at 3 years	Failure rate of the implant	3 Years
Primary	Implant Survival at 5 years	Failure rate of the implant	5 Years
Primary	Implant Survival at 10 years	Failure rate of the implant	10 Years
Primary	Implant Survival at 15 years	Failure rate of the implant	15 Years
Secondary	Functional Outcome at 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	3 Years
Secondary	Functional Outcome at 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	5 Years
Secondary	Functional Outcome at 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	10 Years
Secondary	Functional Outcome at 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	15 Years