Autologous Adipose Tissue, Bilateral Knee Osteoarthritis
Conditions
Keywords
Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue
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.
Interventions
COMBINATION_PRODUCTinjection of Filtered Autologous Adipose Tissue
Single injection of Filtered Autologous Adipose Tissue
DRUGPlacebo
Single injection of Placebo
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis) 2. An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19. 3. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment); 4. Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
Exclusion criteria
1. Patients incapable of understanding and wanting; 2. Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy; 3. 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; 4. Patients with uncontrolled diabetes mellitus; 5. Patients with uncontrolled thyroid metabolic disorders; 6. Patients who abuse alcoholic beverages, drugs or medicines; 7. Patients with misalignment of the lower limbs above 10 degrees; 8. Body Mass Index \> 40; 9. Pregnant or lactating state or intention to become pregnant during the period of participation in the study. 10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening. 11. Patients who have had knee surgery in the 12 months prior to screening. 12. Patients with insufficient abdominal adipose tissue, assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective International Knee Documentation Committee (IKDC - subjective score) | Baseline, 1, 3, 6, 12 and 24 months | Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100) |
| Objective International Knee Documentation Committee (IKDC-Objective Score) | Baseline, 1, 3, 6, 12 and 24 months | 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; |
| Tegner score | Before symptoms onset, at the baseline | 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. |
| Patient Acceptable Symptom State (PASS) | Baseline, 1, 3, 6, 12 and 24 months | 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). |
| EuroQol Visual Analogue Scale (EQ-VAS) | Baseline, 1, 3, 6, 12 and 24 months | 0 - 100 scale where 100 is the best possible healthand 0 is the worst possible health |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline, 1, 3, 6, and 24 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). |
| Numeric Rating Scale (NRS) - Pain | Baseline, 1, 3, 6, 12 and 24 months | 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. |
| Kellgren-Lawrence score | baseline and 24 months | grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade. |
| Magnetic Resonance Imaging | baseline and 12 months | evaluation of the knee joint |
| overall judgement on the treatment | 6, 12 and 24 months | The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial |
| Numeric Rating Scale (NRS) - Function | Baseline, 1, 3, 6, 12 and 24 months | 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. |
Countries
Italy
Outcome results
None listed