Rhizarthrosis
Conditions
Keywords
CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
Brief summary
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
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.
Interventions
DEVICETouch Dual Mobility CMC I Prosthesis
Surgery
Sponsors
Kepler University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective non randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* CMC I Osteoarthritis /Stage III)
Exclusion criteria
* CMC I (osteoarthritis / Other Stage than III) * Anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DASH Score (Disability of Arm Shoulder and Hand Score) | 24 months | DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain | 24 months | patients report about subjective Pain level in average at 6, 12 and 24 months in a VAS (Visual Analog Pain Scale) scale (0-10), whereas 0 is best and 10 worst |
Countries
Austria
Contacts
Primary ContactStefan M Froschauer, MD
Backup ContactOskar Kwasny, Prof
Outcome results
None listed