Clinical trial NCT06997991: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis Thumbs
Keywords: adipose stem cells
Rigenera protocol
trapeziometacarpal arthritis
microfragmented adipose tissue
Lead sponsor: Azienda Ospedaliero, Universitaria Ospedali Riuniti
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in hand and upper limb function measured by the Michigan Hand questionnaire
timeFrame: The MHQ will be administered at three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention, in order to monitor clinical progress and treatment effectiveness.
Secondary outcomes:
measure: Evaluation of: 1. Change from baseline in hand function measured by grip strength 2. Change from baseline in hand function measured by lateral grip strength (tip pinch and tripod pinch) 3. Change in visual analogue scale of pain (VAS) over time 4.Safety
timeFrame: Three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention.
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti
Study officials:
References:
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citation: Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
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citation: Farinelli L, Riccio M, Gigante A, De Francesco F. Pain Management Strategies in Osteoarthritis. Biomedicines. 2024 Apr 4;12(4):805. doi: 10.3390/biomedicines12040805.