Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Overview
- Phase
- Not Applicable
- Intervention
- injection of Filtered Autologous Adipose Tissue
- Conditions
- Bilateral Knee Osteoarthritis
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Filtered Autologous Adipose Tissue
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
Intervention: injection of Filtered Autologous Adipose Tissue
Placebo
based on randomization one of the two knees will be treated with a single injection of Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 12 months
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).
Secondary Outcomes
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, 1, 3, 6, and 24 months)
- Subjective International Knee Documentation Committee (IKDC - subjective score)(Baseline, 1, 3, 6, 12 and 24 months)
- Objective International Knee Documentation Committee (IKDC-Objective Score)(Baseline, 1, 3, 6, 12 and 24 months)
- Tegner score(Before symptoms onset, at the baseline)
- Patient Acceptable Symptom State (PASS)(Baseline, 1, 3, 6, 12 and 24 months)
- EuroQol Visual Analogue Scale (EQ-VAS)(Baseline, 1, 3, 6, 12 and 24 months)
- Numeric Rating Scale (NRS) - Function(Baseline, 1, 3, 6, 12 and 24 months)
- Numeric Rating Scale (NRS) - Pain(Baseline, 1, 3, 6, 12 and 24 months)
- Kellgren-Lawrence score(baseline and 24 months)
- Magnetic Resonance Imaging(baseline and 12 months)
- overall judgement on the treatment(6, 12 and 24 months)