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

Study Overview
=================
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.

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

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Biological: Micro-Fragmented Adipose Tissue (MFAT)
* Drug: Triamcinolone Acetonide 10mg/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFAT<br> | Biological: Micro-Fragmented Adipose Tissue (MFAT)<br>* 1ml of autologous micro-fragmented adipose tissue will be used.<br>|
| Active Comparator: Steroid (Control)<br> | Drug: Triamcinolone Acetonide 10mg/mL<br>* The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.<br>* Other names: Kenalog-10;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, Month 12 |