Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

NCT ID: NCT05047744

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2023-12-31

Brief Summary

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The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

Detailed Description

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The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Conditions

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Rhizarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective non randomized Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthesis Cohort

Surgery dual mobility Prosthesis

Group Type EXPERIMENTAL

Touch Dual Mobility CMC I Prosthesis

Intervention Type DEVICE

Surgery

Interventions

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Touch Dual Mobility CMC I Prosthesis

Surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CMC I Osteoarthritis /Stage III)

Exclusion Criteria

* CMC I (osteoarthritis / Other Stage than III)
* Anticoagulation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kepler Universitaetsklinikum GmbH

Linz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Stefan M Froschauer, MD

Role: CONTACT

004373278061020

Oskar Kwasny, Prof

Role: CONTACT

004373278061010

Facility Contacts

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Stefan M Froschauer, MD

Role: primary

+4373278061020

Other Identifiers

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KUK-UNF-21-001

Identifier Type: -

Identifier Source: org_study_id

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