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

Phase 2

Withdrawn

• Conditions: Arthritis
• Interventions: Biological: Micro-Fragmented Adipose Tissue (MFAT); Drug: Triamcinolone Acetonide 10mg/mL

• Registration Number: NCT05005000
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-13
• Study Start: 2022-05-12
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MFAT	Micro-Fragmented Adipose Tissue (MFAT)	-
Steroid (Control)	Triamcinolone Acetonide 10mg/mL	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States