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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
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Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.
Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.
Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVF | Experimental | Thumb carpometacarpal injection with adipose-derived SVF combined with splinting |
|
| Splint | Active Comparator | Thumb carpometacarpal osteoarthrosis treated with splinting only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVF | Procedure | Adipose-derived stromal vascular fraction |
| |
| Splint |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Visual Analogue Scale) | The VAS is derived by health care professional question of pain in scale 0 to 100 mm (0 mm =no pain, 100 mm =worst possible pain) | 6 months |
| Patient-Rated Wrist Evaluation (PRWE) | The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Global improvement | Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better | 6 months |
| Grip strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuli Aspinen, M.D., Ph.D. | Contact | +358406360546 | samuli.aspinen@hus.fi | |
| Jussi Kosola, M.D., Ph.D. | Contact | jussi.kosola@helsinki.fi |
| Name | Affiliation | Role |
|---|---|---|
| Samuli Aspinen, M.D., Ph.D. | HUS Töölö Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital (Helsinki University Hospital) | Recruiting | Helsinki | Finland |
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| ID | Term |
|---|---|
| D013165 | Splints |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Other |
Thumb brace (Actimove® Rhizo Forte) |
|
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side |
| 6 months |
| Key pinch strength | Key pinch strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side | 6 months |
| Michigan Hand Outcomes Questionnaire (MHQ) | The MHQ comprises of 37 core questions to measure hand-specific outcomes containing six distinct scales: overall hand function, activities of daily living, pain, work performance, aesthetics and patient satisfaction with hand function. | 6 months |
| Complications | Incidence of complications (hemaetoma, injection site infection etc.) | 6 months |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |