Status:
UNKNOWN
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
Lead Sponsor:
Töölö Hospital
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Thumb Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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 spl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04455763
Start Date
January 14 2021
End Date
March 1 2023
Last Update
January 19 2021
Active Locations (1)
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1
Töölö Hospital (Helsinki University Hospital)
Helsinki, Finland