Prospective Clinical Study to Evaluate the Safety and Efficacy of Intraarticular Administration of Micro-grafts of Adipose Tissue (Adipo-micro-grafts) in the Treatment of Osteoarthritis of the Trapezium-metacarpal Joint (ADIPO_MICRO_GRAFTS_1) (AMG_1)

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Status: Completed

Conditions: Osteoarthritis; Osteoarthritis Thumbs

Treatments: Procedure: adipose micro-grafts injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06997991

1155772|26/07/2022

Details and patient eligibility

About

The objective of this interventional study is the Change in the Michigan Hand Questionnaire (MHQ) score over time in subjects with Eaton Littler grade II and III trapeziometacarpal osteoarthritis.

The main questions to be answered are:

• primary outcomes: Differences in the change in the MHQ scale measured as a reduction in the score result of 12 points within 6 months from preoperative.
• secondary outcomes: Change from baseline in hand function measured by grip strength (Gripstrength); Change from baseline in hand function by lateral grip strength (tippinch and tripodpinch); Change in the Visual Analogue Scale (VAS) pain scale before the procedure then after the procedure, at 1, 3 and 6 months; Safety and tolerance of the treatments.

Enrollment: 25 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed written informed consent.
2. Male or female aged ≥ 40 and ≤ 75 years
3. Normal axial alignment
4. Eaton/Littler stage 2-3
5. MHQ pain scale
6. Willingness to participate in all scheduled follow-ups
7. Willingness to abstain from taking level 2 analgesics and opioids for the duration of the study. NSAIDs and Paracetamol are permitted.

Exclusion criteria

1. Pregnant and/or breastfeeding women.
2. If a woman, of childbearing age and the subject is not using a highly effective method of birth control and is not willing to use it during participation in the clinical trial. Highly effective methods of birth control include: combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal); progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence;
3. Intra-articular injection within 3 months of treatment.
4. Immunocompromised for reasons such as corticosteroid therapy, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
5. Previous hand surgery within the last 6 months
6. History of connective tissue disease, such as systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
7. Infections in the trapezium-metacarpal joint, skin disease or infections in the area of the injection site

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Adipose micro-grafts

Experimental group

Description:

Patients were positioned supine, and local anesthesia was administered. A small incision was made to introduce a blunt cannula attached to a Luer-lock 60-cc syringe. Klein sterile solution, containing saline and lidocaine, was injected into the subcutaneous fat layer of either the abdominal or thigh region. Subsequently, approximately 30 mL of adipose tissue was extracted. The collected lipoaspirate was processed under sterile conditions in a closed system using Rigenera® technology (HBW, Turin, Italy). Before injecting, the skin was sterilely dressed, and the injection of 2-3 mL of aMAT was performed into TMC joint with a superolateral approach, under fluoroscopic X-ray guidance and using a disposable 20G needle and a 3 mL Luer-Lock Syringe.

Treatment:

Procedure: adipose micro-grafts injection