Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis (NCT04455763) | Clinical Trial Compass
UnknownNot Applicable
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
Finland60 participantsStarted 2021-01-14
Plain-language summary
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).
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.