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NCT Number: NCT04567732

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bilateral Knee Osteoarthritis Arthritis Autologous Adipose Tissue Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 19.
  • 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.
  • Patients who have had knee surgery in the 12 months prior to screening.
  • Patients with insufficient abdominal adipose tissue, assessed by the investigator

Treatment and study plan

injection of Filtered Autologous Adipose Tissue

Combination Product

Single injection of Filtered Autologous Adipose Tissue

Placebo

Drug

Single injection of Placebo

Primary outcomes

  1. 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

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 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).

  2. Subjective International Knee Documentation Committee (IKDC - subjective score)

    Time frame: 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)

  3. Objective International Knee Documentation Committee (IKDC-Objective Score)

    Time frame: 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;

  4. Tegner score

    Time frame: 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".

  5. Patient Acceptable Symptom State (PASS)

    Time frame: 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).

  6. EuroQol Visual Analogue Scale (EQ-VAS)

    Time frame: Baseline, 1, 3, 6, 12 and 24 months

    0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"

  7. Numeric Rating Scale (NRS) - Function

    Time frame: 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.

  8. Numeric Rating Scale (NRS) - Pain

    Time frame: 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.

  9. Kellgren-Lawrence score

    Time frame: baseline and 24 months

    grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.

  10. Magnetic Resonance Imaging

    Time frame: baseline and 12 months

    evaluation of the knee joint

  11. overall judgement on the treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Sep 28, 2020
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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