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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2026-04-30

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.

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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.

Conditions

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Bilateral Knee Osteoarthritis Autologous Adipose Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Filtered Autologous Adipose Tissue

based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue

Group Type EXPERIMENTAL

injection of Filtered Autologous Adipose Tissue

Intervention Type COMBINATION_PRODUCT

Single injection of Filtered Autologous Adipose Tissue

Placebo

based on randomization one of the two knees will be treated with a single injection of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single injection of Placebo

Interventions

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injection of Filtered Autologous Adipose Tissue

Single injection of Filtered Autologous Adipose Tissue

Intervention Type COMBINATION_PRODUCT

Placebo

Single injection of Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No