A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: injection of autologous micro-fragmented adipose tissue (aMAT)
* Biological: injection of Platelet-rich Plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients provided written informed consent; Patients aged between 18 and 75 years; Knee symptomatic OA (Kellgren-Lawrence grade 1-4) Failure of conservative treatment for at least 3 months; Patients agreed to actively participate in the rehabilitation protocol and follow-up program; Male or female patients; Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment. Exclusion Criteria Patients incapable to understanding and will; Patients participating in previous, concurrent or not, trials (ongoing or completed within three months); Patients surgically treated for the same defect within one year; Patients affected by malignancy; Patients affected by metabolic or thyroid disorders; Patients used to alcohol or drug (medication) abuse; Patients affected by synovitis; Varus or valgus misalignment exceeding 15°; Body Mass Index > 40; Patients with trauma within 6 months pre-operative.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)<br>injection of aMAT obtained with Lipogems® technology. | Biological: injection of autologous micro-fragmented adipose tissue (aMAT)<br>* adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.<br>|
| Active Comparator: platelet-rich plasma (PRP)<br>single injection of platelet-rich plasma | Biological: injection of Platelet-rich Plasma (PRP)<br>* injection of platelet-rich plasma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Change in KOOS score from baseline to follow up | Time Frame: 3,6, 12, 24 months evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OA, aMAT, PRP