An interventional study of adipose micro-grafts injection in Osteoarthritis and Osteoarthritis Thumbs, sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti. Completed at 1 site in Italy. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Azienda Ospedaliero, Universitaria Ospedali Riuniti · Not applicable, Interventional, and Treatment
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:
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Azienda Ospedaliero, Universitaria Ospedali Riuniti is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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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.
Procedure: adipose micro-grafts injection
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.
Change in hand and upper limb function measured by the Michigan Hand questionnaire
The Michigan Hand Questionnaire (MHQ) is a validated instrument specifically designed to assess hand function and the impact of upper extremity conditions on quality of life. The questionnaire explores six main dimensions: general function, activities of daily living (ADL), pain, aesthetics, patient satisfaction, and work function. The score for each domain is converted to a scale of 0 to 100, where: 100 represents the best perceived functional outcome, 0 represents the worst outcome. For some subsections (such as pain), the scale is reversed to ensure correct interpretation of the scores.
Time frame: 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.
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
1. The grip strength of the treated hand is measured with the JAMAR manual hydraulic dynamometer in kilograms of pressure by taking the greatest force of three successive attempts with 15 seconds of rest between each attempt. 2. The lateral grip strength (tippinch: between the thumb and index finger; tripodpinch: between the thumb, index finger and middle finger) of the treated hand is measured with the mechanical grip meter in kilograms of pressure by taking the greatest force of three successive attempts with 15 seconds of rest between each attempt. 3. Differences in the pain scale measured as a reduction in pain perception. Pain in the treated joint will be assessed by a visual analogue scale that requires the patient to respond by placing a vertical line on a 100mm scale where 0 corresponds to "no pain" and 100 "unbearable pain". 4. Evaluation of the safety and tolerability of the treatment, detected by examining the adverse events expected at local level.
Time frame: Three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention.
Plan to share: Undecided — IPD will not be shared due to confidentiality and regulatory constraints, except for possible use in scientific publications in anonymized or aggregated format.
Ran from Jul 2022 to primary completion in Sep 2023, 13 months.
Of 1,126 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 13 months is below that.
Counting every sponsor, half of 1,315 studies reached it within 19 months; a quarter within 8 and three quarters within 39.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero, Universitaria Ospedali Riuniti