Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

Conditions
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Bilateral Knee Osteoarthritis, Autologous Adipose Tissue

Intervention / Treatment
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* Combination Product: injection of Filtered Autologous Adipose Tissue
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis) An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment); Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up; Exclusion Criteria: Patients incapable of understanding and wanting; Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy; Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis; Patients with uncontrolled diabetes mellitus; Patients with uncontrolled thyroid metabolic disorders; Patients who abuse alcoholic beverages, drugs or medicines; Patients with misalignment of the lower limbs above 10 degrees; Body Mass Index > 40; Pregnant or lactating state or intention to become pregnant during the period of participation in the study. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening. Patients who have had knee surgery in the 12 months prior to screening. Patients with insufficient abdominal adipose tissue, assessed by the investigator

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filtered Autologous Adipose Tissue<br>based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue | Combination Product: injection of Filtered Autologous Adipose Tissue<br>* Single injection of Filtered Autologous Adipose Tissue<br>|
| Placebo Comparator: Placebo<br>based on randomization one of the two knees will be treated with a single injection of Placebo | Drug: Placebo<br>* Single injection of Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 healthand 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue