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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose micro-grafts | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adipose micro-grafts injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Ospedali Riuniti | Ancona | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36233654 | Background | Mayoly A, Witters M, Jouve E, Bec C, Iniesta A, Kachouh N, Veran J, Grimaud F, Zavarro AC, Fernandez R, Bendahan D, Giraudo L, Dumoulin C, Chagnaud C, Casanova D, Sabatier F, Legre R, Jaloux C, Magalon J. Intra Articular Injection of Autologous Microfat and Platelets-Rich Plasma in the Treatment of Wrist Osteoarthritis: A Pilot Study. J Clin Med. 2022 Sep 29;11(19):5786. doi: 10.3390/jcm11195786. | |
| 28922320 |
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IPD will not be shared due to confidentiality and regulatory constraints, except for possible use in scientific publications in anonymized or aggregated format.
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|
| Three key time points: before treatment, 3 months, and 6 months after the therapeutic intervention. |
| Background |
| Erne HC, Cerny MK, Ehrl D, Bauer AT, Schmauss V, Moog P, Broer PN, Loew S, Schmauss D. Autologous Fat Injection versus Lundborg Resection Arthroplasty for the Treatment of Trapeziometacarpal Joint Osteoarthritis. Plast Reconstr Surg. 2018 Jan;141(1):119-124. doi: 10.1097/PRS.0000000000003913. |
| 18182958 | Background | Cook GS, Lalonde DH. MOC-PSSM CME article: Management of thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-9. doi: 10.1097/01.prs.0000294708.70340.8c. |
| 34638538 | Background | De Francesco F, Gravina P, Busato A, Farinelli L, Soranzo C, Vidal L, Zingaretti N, Zavan B, Sbarbati A, Riccio M, Gigante A. Stem Cells in Autologous Microfragmented Adipose Tissue: Current Perspectives in Osteoarthritis Disease. Int J Mol Sci. 2021 Sep 22;22(19):10197. doi: 10.3390/ijms221910197. |
| 31908163 | Background | 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. |
| 18279766 | Background | Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. |
| 38672160 | Background | 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. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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