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

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ClinicalTrials.gov Identifier: NCT04567732
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bilateral Knee Osteoarthritis Autologous Adipose Tissue Combination Product: injection of Filtered Autologous Adipose Tissue Drug: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Filtered Autologous Adipose Tissue
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
 Combination Product: injection of Filtered Autologous Adipose Tissue
Single injection of Filtered Autologous Adipose Tissue
Placebo Comparator: Placebo
based on randomization one of the two knees will be treated with a single injection of Placebo
 Drug: Placebo
Single injection of Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567732


Contacts
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Contact: Daniele Andreani, M.Sc. 0516366072 daniele.andreani@ior.it

Locations
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Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40124
Contact: Daniele Andreani, M.Sc.       daniele.andreani@ior.it   
Contact: Roberta Licciardi, M.Sc       roberta.licciardi@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
More Information
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Publications:

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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04567732    
Other Study ID Numbers: AdipoBil
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
Arthrosis
Osteoarthrosis
Degenerative joint disease
 Knee degenerative joint disease.
Bilateral
Fat tissue
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases