Status:
COMPLETED
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)
Lead Sponsor:
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Conditions:
Osteoarthritis
Osteoarthritis Thumbs
Eligibility:
All Genders
40-75 years
Phase:
NA
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. Th...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Male or female aged ≥ 40 and ≤ 75 years
- Normal axial alignment
- Eaton/Littler stage 2-3
- MHQ pain scale
- Willingness to participate in all scheduled follow-ups
- Willingness to abstain from taking level 2 analgesics and opioids for the duration of the study. NSAIDs and Paracetamol are permitted.
Exclusion
- Pregnant and/or breastfeeding women.
- 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;
- Intra-articular injection within 3 months of treatment.
- Immunocompromised for reasons such as corticosteroid therapy, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
- Previous hand surgery within the last 6 months
- History of connective tissue disease, such as systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- Infections in the trapezium-metacarpal joint, skin disease or infections in the area of the injection site
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06997991
Start Date
July 26 2022
End Date
September 1 2023
Last Update
May 31 2025
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Ospedali Riuniti
Ancona, Italy