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

K

Kepler University Hospital

Status

Enrolling

Conditions

Rhizarthrosis

Treatments

Device: Touch Dual Mobility CMC I Prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT05047744
KUK-UNF-21-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • CMC I Osteoarthritis /Stage III)

Exclusion criteria

  • CMC I (osteoarthritis / Other Stage than III)
  • Anticoagulation

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Prosthesis Cohort
Experimental group
Description:
Surgery dual mobility Prosthesis
Treatment:
Device: Touch Dual Mobility CMC I Prosthesis

Trial contacts and locations

1

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Central trial contact

Stefan M Froschauer, MD; Oskar Kwasny, Prof

Data sourced from clinicaltrials.gov

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