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NCT Number: NCT03611023

Study of the Touch® Trapezo-metacarpal Prosthesis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Complications Due to Internal Joint Prosthesis Thumb Osteoarthritis

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital du Gier

Saint-Chamond, 42740, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implant Survival at 3 years

    Time frame: 3 Years

    Failure rate of the implant

  2. Implant Survival at 5 years

    Time frame: 5 Years

    Failure rate of the implant

  3. Implant Survival at 10 years

    Time frame: 10 Years

    Failure rate of the implant

  4. Implant Survival at 15 years

    Time frame: 15 Years

    Failure rate of the implant

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Groupe Concepteur Touch

Other

Registry information

Official study title

Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

Important dates

Study start
2018
Primary completion
2036
Study completion
2036
First posted
Aug 2, 2018
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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