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The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.
After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.
All patients who meet the inclusion criteria and giving written informed consent will be randomized.
Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.
After the treatment patients will be followed up to 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filtered Autologous Adipose Tissue | Experimental | based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue |
|
| Placebo | Placebo Comparator | based on randomization one of the two knees will be treated with a single injection of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of Filtered Autologous Adipose Tissue | Combination Product | Single injection of Filtered Autologous Adipose Tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68). | Baseline, 1, 3, 6, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23051701 | Background | Bianchi F, Maioli M, Leonardi E, Olivi E, Pasquinelli G, Valente S, Mendez AJ, Ricordi C, Raffaini M, Tremolada C, Ventura C. A new nonenzymatic method and device to obtain a fat tissue derivative highly enriched in pericyte-like elements by mild mechanical forces from human lipoaspirates. Cell Transplant. 2013;22(11):2063-77. doi: 10.3727/096368912X657855. Epub 2012 Oct 8. | |
| 20444320 |
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| Placebo | Drug | Single injection of Placebo |
|
| Subjective International Knee Documentation Committee (IKDC - subjective score) | Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100) | Baseline, 1, 3, 6, 12 and 24 months |
| Objective International Knee Documentation Committee (IKDC-Objective Score) | The presence of effusions and the degree of movement of the knee are evaluated, the worst value of one of these parameters determines the final value of the IKDC degree. There are four grades (A, B, C, D) which respectively identify a knee rated as normal, near normal, abnormal and severely abnormal; | Baseline, 1, 3, 6, 12 and 24 months |
| Tegner score | describe and assess the sport activity with a score ranging from 0 to 10, where 0 means "inability" and 10 represent ability to perform "competitive sports". | Before symptoms onset, at the baseline |
| Patient Acceptable Symptom State (PASS) | tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no). | Baseline, 1, 3, 6, 12 and 24 months |
| EuroQol Visual Analogue Scale (EQ-VAS) | 0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health" | Baseline, 1, 3, 6, 12 and 24 months |
| Numeric Rating Scale (NRS) - Function | the scale is to expect the patient to select the number that best describes their functional disability status, from 0 to 10. The higher the value indicated the higher the degree of disability will be. | Baseline, 1, 3, 6, 12 and 24 months |
| Numeric Rating Scale (NRS) - Pain | the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 means worst possible pain. | Baseline, 1, 3, 6, 12 and 24 months |
| Kellgren-Lawrence score | grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade. | baseline and 24 months |
| Magnetic Resonance Imaging | evaluation of the knee joint | baseline and 12 months |
| overall judgement on the treatment | The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial | 6, 12 and 24 months |
| Background |
| Tremolada C, Palmieri G, Ricordi C. Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine. Cell Transplant. 2010;19(10):1217-23. doi: 10.3727/096368910X507187. Epub 2010 May 4. |
| 26240572 | Background | Perdisa F, Gostynska N, Roffi A, Filardo G, Marcacci M, Kon E. Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence. Stem Cells Int. 2015;2015:597652. doi: 10.1155/2015/597652. Epub 2015 Jul 9. |
| 25108907 | Background | Koh YG, Kwon OR, Kim YS, Choi YJ. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. 2014 Nov;30(11):1453-60. doi: 10.1016/j.arthro.2014.05.036. Epub 2014 Aug 6. |
| 25581339 | Background | Bellamy N, Hochberg M, Tubach F, Martin-Mola E, Awada H, Bombardier C, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):972-80. doi: 10.1002/acr.22538. |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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