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The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59 patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three, six, twelve, and twenty-four months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) | Experimental | injection of aMAT obtained with Lipogems® technology. |
|
| platelet-rich plasma (PRP) | Active Comparator | single injection of platelet-rich plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of autologous micro-fragmented adipose tissue (aMAT) | Biological | adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety of the procedure, documenting characteristics and incidence of adverse events.(AE) | Time Frame: 24 months evaluation |
| clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score) | change in IKDC and KOOS score | Time Frame: 6 months evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score | Change in IKDC Subjective score from baseline to follow up | Time Frame: 6, 24 months evaluation |
| stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Versari | Contact | +39 02 37072408 | silvia.versari@lipogems.eu | |
| Marco Tiana | Contact | +39 02 37072408 | marco.tiana@lipogems.eu |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Versari | Lipogems International spa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Recruiting | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| injection of Platelet-rich Plasma (PRP) | Biological | injection of platelet-rich plasma |
|
Change in KOOS score from baseline to follow up |
| Time Frame: 3,6, 12, 24 months evaluation |
| D012216 |
| Rheumatic Diseases |