Arthritis
Conditions
Brief 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.
Interventions
BIOLOGICALMicro-Fragmented Adipose Tissue (MFAT)
1ml of autologous micro-fragmented adipose tissue will be used.
The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years old or older; male and female patients 2. Eaton-Glickel stage 2-3 thumb CMC arthritis 3. Failed conservative treatment (i.e. hand therapy, pain medications, splinting) 4. Able to provide informed consent
Exclusion criteria
1. Pregnancy/breastfeeding 2. Inflammatory or posttraumatic arthritis 3. Prior thumb base trauma or surgery 4. Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site 5. Active local or systemic malignancy 6. Known allergy to any study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Score on Pain Visual Analog Scale (VAS) | Baseline, Month 12 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on Thumb Disability Exam (TDX) | Baseline, Month 12 | 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. |
| Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score | Baseline, Month 12 | 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. |
| Change in Kapandji Range of Motion Score | Baseline, Month 12 | 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. |
Countries
United States
Outcome results
None listed