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

NCT05005000 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 21-00996
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Score on Thumb Disability Exam (TDX)

  Baseline, Month 12

• Change in Shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score

  Baseline, Month 12

• Change in Kapandji Range of Motion Score

  Baseline, Month 12

Study Arms (2)

MFAT

EXPERIMENTAL

Biological: Micro-Fragmented Adipose Tissue (MFAT)

Steroid (Control)

ACTIVE COMPARATOR

Drug: Triamcinolone Acetonide 10mg/mL

Interventions

Micro-Fragmented Adipose Tissue (MFAT) BIOLOGICAL

1ml of autologous micro-fragmented adipose tissue will be used.

MFAT

Triamcinolone Acetonide 10mg/mL DRUG

The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.

Also known as: Kenalog-10

Steroid (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jacques Hacquebord, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 13, 2021
• Study Start: May 12, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Jacques.Hacquebord@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)