Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis

Study Overview
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Brief Summary
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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).

Official Title
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Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Procedure: SVF
* Other: Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-70 years Eaton-Glickel II thumb CMC osteoarthrosis Symptom duration > 3 months Pain visual analogue score > 30 mm < 3 months of treatment with thumb splinting American Society of Anaesthesiologists physical status (ASA) I-III Fluent in written and spoken Finnish Exclusion Criteria: Age <40 or >70 years Eaton-Glickel I, III-IV Symptom duration < 3 months Pain VAS < 30 mm Post-traumatic osteoarthrosis of thumb CMC I Rheumatoid arthritis or other inflammatory joint disease The use of per oral corticosteroids or other immunomodulatory drugs Less than 6 months after another operation of the same upper limb Other condition of the same upper limb requiring surgery Malnutrition Neurological condition affecting upper limb function Heavy smoking (> 20 cigarettes per day) Alcohol or drug abuse Previous history or active cancer Previous history of allergic reaction to local anaesthetic

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF<br>Thumb carpometacarpal injection with adipose-derived SVF combined with splinting | Procedure: SVF<br>* Adipose-derived stromal vascular fraction<br>Other: Splint<br>* Thumb brace (Actimove® Rhizo Forte)<br>|
| Active Comparator: Splint<br>Thumb carpometacarpal osteoarthrosis treated with splinting only | Other: Splint<br>* Thumb brace (Actimove® Rhizo Forte)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thumb Osteoarthrosis, Stromal Vascular Fraction