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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MFAT

Group Type EXPERIMENTAL

Micro-Fragmented Adipose Tissue (MFAT)

Intervention Type BIOLOGICAL

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

Steroid (Control)

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide 10mg/mL

Intervention Type DRUG

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

Interventions

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Micro-Fragmented Adipose Tissue (MFAT)

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

Intervention Type BIOLOGICAL

Triamcinolone Acetonide 10mg/mL

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

Intervention Type DRUG

Other Intervention Names

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Kenalog-10

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No