Study of the Touch® Trapezo-metacarpal Prosthesis

Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03611023

Enrollment

350

Registered

2018-08-02

Start date

2018-10-01

Completion date

2036-09-30

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications Due to Internal Joint Prosthesis, Thumb Osteoarthritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Implant Survival at 15 years	15 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 10 years	10 Years	Failure rate of the implant

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results