Clinical trial NCT04567732: Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Official title: Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bilateral Knee Osteoarthritis
Autologous Adipose Tissue
Keywords: Arthrosis
Osteoarthrosis
Degenerative joint disease
Knee degenerative joint disease.
Bilateral
Fat tissue
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 months
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, 1, 3, 6, and 24 months
measure: Subjective International Knee Documentation Committee (IKDC - subjective score)
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Objective International Knee Documentation Committee (IKDC-Objective Score)
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Tegner score
timeFrame: Before symptoms onset, at the baseline
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Numeric Rating Scale (NRS) - Function
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Numeric Rating Scale (NRS) - Pain
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Kellgren-Lawrence score
timeFrame: baseline and 24 months
measure: Magnetic Resonance Imaging
timeFrame: baseline and 12 months
measure: overall judgement on the treatment
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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