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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Single injection of Filtered Autologous Adipose Tissue
Single injection of Placebo
Istituto Ortopedico Rizzoli
Bologna, Italy
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).
Time frame: 12 months
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).
Time frame: 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)
Time frame: 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;
Time frame: 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".
Time frame: Before symptoms onset, at the baseline
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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).
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 24 months
Magnetic Resonance Imaging
evaluation of the knee joint
Time frame: 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
Time frame: 6, 12 and 24 months