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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
1ml of autologous micro-fragmented adipose tissue will be used.
The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.
NYU Langone Health
New York, New York, United States
Percent Change in Score on Pain Visual Analog Scale (VAS)
Pain severity scores will be assessed by use of a visual analog scale (VAS; total range = 0-10; 0 = no pain, 10 = worst pain imaginable)
Time frame: Baseline, Month 12
Change in Score on Thumb Disability Exam (TDX)
TDX consists of 20 questions and assess the function of the participant's thumbs over the past week. Each question is scored from 1 (not difficult) to 5 (unable). TDX is scored on a scale of 1 to 100, with a higher score indicating a greater degree of disability in the thumb.
Time frame: Baseline, Month 12
Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
QuickDASH consists of 11 questions -- the participants are asked to rate their ability to do activities in the last week on a scale of 1 (no difficulty) to 5 (unable). The disability/symptom score is calculated by ((sum of n responses/n)-1)x25, where n is equal to the number of completed responses. The total score ranges from 0 to 250; higher scores indicate greater degree of disability.
Time frame: Baseline, Month 12
Change in Kapandji Range of Motion Score
A Kapandji score is used to assess the movement of opposition (being able to touch one's thumb to areas of one's hand). It is vital in hand function and grip. The total score ranges from 1 to 10; a higher score indicates the thumb being able to touch a further area on the hand.
Time frame: Baseline, Month 12
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