Osteoarthrosis of the Carpometacarpal Joint of the Thumb Clinical Trial
— RASSHOfficial title:
Outcomes of Treatment for Trapeziometacarpal Osteoarthritis Using a Comprehensive Core Set.
Verified date | November 2013 |
Source | Schulthess Klinik |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.
Status | Completed |
Enrollment | 177 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All adult patients diagnosed for TMC OA - signed informed consent Exclusion Criteria: - rheumatoid arthritis, - legal incompetent patients, - patients already included in the study for the other hand, - insufficient knowledge of the German language |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Switzerland | Schulthess Klinik | Zurich |
Lead Sponsor | Collaborator |
---|---|
Schulthess Klinik | Leiden University Medical Center |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Michigan Hand Questionnaire - pain subscale | 12 months | No | |
Secondary | Disabilities of the Arm, Shoulder and Hand Questionnaire | 12 months | No |
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