Study of the Touch® Trapezo-metacarpal Prosthesis

November 26, 2019 updated by: Dr Cyril Falaise, Groupe Concepteur Touch

Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Chamond, France, 42740
        • Hôpital du Gier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival at 3 years
Time Frame: 3 Years
Failure rate of the implant
3 Years
Implant Survival at 5 years
Time Frame: 5 Years
Failure rate of the implant
5 Years
Implant Survival at 10 years
Time Frame: 10 Years
Failure rate of the implant
10 Years
Implant Survival at 15 years
Time Frame: 15 Years
Failure rate of the implant
15 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome at 3 years
Time Frame: 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
Functional Outcome at 5 years
Time Frame: 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
Functional Outcome at 10 years
Time Frame: 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
Functional Outcome at 15 years
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Concepteur Touch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2036

Study Completion (ANTICIPATED)

September 1, 2036

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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