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

Not Applicable

Recruiting

• Conditions: Autologous Adipose Tissue; Bilateral Knee Osteoarthritis
• Interventions: Combination Product: injection of Filtered Autologous Adipose Tissue; Drug: Placebo

• Registration Number: NCT04567732
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2021-02-22
• Primary Completion: 2022-04-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 health"and 0 is the "worst possible health"
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.
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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy