Trials / Unknown
UnknownNCT04455763
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Töölö Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SVF | Adipose-derived stromal vascular fraction |
| OTHER | Splint | Thumb brace (Actimove® Rhizo Forte) |
Timeline
- Start date
- 2021-01-14
- Primary completion
- 2022-09-01
- Completion
- 2023-03-01
- First posted
- 2020-07-02
- Last updated
- 2021-01-19
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04455763. Inclusion in this directory is not an endorsement.