NCT05005000

Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Micro-Fragmented Adipose Tissue (MFAT)	1ml of autologous micro-fragmented adipose tissue will be used.
DRUG	Triamcinolone Acetonide 10mg/mL	The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.

Timeline

• Start date: 2022-05-12
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2021-08-13
• Last updated: 2024-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study