Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
Official title:
Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
Verified date | August 2016 |
Source | Schulthess Klinik |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and successfully used in TMC OA surgery and therefore represents an acceptable alternative for avoiding possible donor-site morbidity. However, there are no randomised controlled trials (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared. Only with an RCT design it is possible to gain evidence about the advantages of one treatment method over another. The main objective of the study is the comparison between two surgical techniques for TMC OA: The resection interposition suspension arthroplasty using a part of the flexor carpi radialis tendon as interpositional material and using the GraftJacket as interpositional material.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - All adult patients diagnosed for TMC OA - willing to participate and provide informed consent Exclusion criteria: - Patients with rheumatoid arthritis, - pregnant women, - legal incompetent patients, - persons with insufficient knowledge of the German language to complete the questionnaires |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Schulthess Klinik | Zurich |
Lead Sponsor | Collaborator |
---|---|
Schulthess Klinik |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Costs, Treatment satisfaction, objective and subjective function | preOP, 6 weeks, 3, 6, and 12months post OP | No | |
Primary | Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery | preOP, 6 weeks, 3, 6, and 12months post OP | No | |
Secondary | Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis. | preOP, 6 weeks, 3, 6, and 12months post OP | Yes |
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