Study of the Touch® Trapezo-metacarpal Prosthesis

N/AActive Not RecruitingNCT03611023

Groupe Concepteur Touch350 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Complications Due to Internal Joint Prosthesis Thumb Osteoarthritis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Hopital du Gier

Saint-Chamond, France

Outcomes

Primary Outcomes

Implant Survival at 3 years

Failure rate of the implant

Time frame: 3 Years

Implant Survival at 5 years

Failure rate of the implant

Time frame: 5 Years

Implant Survival at 10 years

Failure rate of the implant

Time frame: 10 Years

Implant Survival at 15 years

Failure rate of the implant

Time frame: 15 Years

Secondary Outcomes

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

Time frame: 3 Years

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

Time frame: 5 Years

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

Time frame: 10 Years

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

Data from ClinicalTrials.gov

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