Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Sex
Ages
Volunteers
Inclusion criteria
- 18 years old or older; male and female patients
- Eaton-Glickel stage 2-3 thumb CMC arthritis
- Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
- Able to provide informed consent
Exclusion criteria
- Pregnancy/breastfeeding
- Inflammatory or posttraumatic arthritis
- Prior thumb base trauma or surgery
- Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site
- Active local or systemic malignancy
- Known allergy to any study drug
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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