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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05005000
• Other study ID #: 21-00996
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 12, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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