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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    60
  • sponsor
    Töölö Hospital
Updated on 30 January 2021

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).

Details
Condition Thumb Osteoarthritis
Treatment Splint, SVF
Clinical Study IdentifierNCT04455763
SponsorTöölö Hospital
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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