Back to resultsBilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Primary Purpose
Bilateral Knee Osteoarthritis, Autologous Adipose Tissue
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
injection of Filtered Autologous Adipose Tissue
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Knee Osteoarthritis focused on measuring Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Filtered Autologous Adipose Tissue
Placebo
Arm Description
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
based on randomization one of the two knees will be treated with a single injection of Placebo
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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)
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)
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
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)
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)
0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"
Numeric Rating Scale (NRS) - Function
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
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
grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.
Magnetic Resonance Imaging
evaluation of the knee joint
overall judgement on the treatment
The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial
Full Information
NCT ID
NCT04567732
First Posted
September 23, 2020
Last Updated
July 18, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04567732
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Knee Osteoarthritis, Autologous Adipose Tissue
Keywords
Arthrosis, Osteoarthrosis, Degenerative joint disease, Knee degenerative joint disease., Bilateral, Fat tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Filtered Autologous Adipose Tissue
Arm Type
Experimental
Arm Description
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
based on randomization one of the two knees will be treated with a single injection of Placebo
Intervention Type
Combination Product
Intervention Name(s)
injection of Filtered Autologous Adipose Tissue
Intervention Description
Single injection of Filtered Autologous Adipose Tissue
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single injection of Placebo
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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).
Time Frame
Baseline, 1, 3, 6, and 24 months
Title
Subjective International Knee Documentation Committee (IKDC - subjective score)
Description
Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100)
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Objective International Knee Documentation Committee (IKDC-Objective Score)
Description
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;
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Tegner score
Description
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".
Time Frame
Before symptoms onset, at the baseline
Title
Patient Acceptable Symptom State (PASS)
Description
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).
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
EuroQol Visual Analogue Scale (EQ-VAS)
Description
0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Numeric Rating Scale (NRS) - Function
Description
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.
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Numeric Rating Scale (NRS) - Pain
Description
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.
Time Frame
Baseline, 1, 3, 6, 12 and 24 months
Title
Kellgren-Lawrence score
Description
grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.
Time Frame
baseline and 24 months
Title
Magnetic Resonance Imaging
Description
evaluation of the knee joint
Time Frame
baseline and 12 months
Title
overall judgement on the treatment
Description
The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial
Time Frame
6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Andreani, M.Sc.
Phone
0516366072
Email
daniele.andreani@ior.it
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Andreani, M.Sc.
Email
daniele.andreani@ior.it
First Name & Middle Initial & Last Name & Degree
Roberta Licciardi, M.Sc
Email
roberta.licciardi@ior.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
23051701
Citation
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Results Reference
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PubMed Identifier
20444320
Citation
Tremolada C, Palmieri G, Ricordi C. Adipocyte transplantation and stem cells: plastic surgery meets regenerative medicine. Cell Transplant. 2010;19(10):1217-23. doi: 10.3727/096368910X507187. Epub 2010 May 4.
Results Reference
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PubMed Identifier
26240572
Citation
Perdisa F, Gostynska N, Roffi A, Filardo G, Marcacci M, Kon E. Adipose-Derived Mesenchymal Stem Cells for the Treatment of Articular Cartilage: A Systematic Review on Preclinical and Clinical Evidence. Stem Cells Int. 2015;2015:597652. doi: 10.1155/2015/597652. Epub 2015 Jul 9.
Results Reference
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PubMed Identifier
25108907
Citation
Koh YG, Kwon OR, Kim YS, Choi YJ. Comparative outcomes of open-wedge high tibial osteotomy with platelet-rich plasma alone or in combination with mesenchymal stem cell treatment: a prospective study. Arthroscopy. 2014 Nov;30(11):1453-60. doi: 10.1016/j.arthro.2014.05.036. Epub 2014 Aug 6.
Results Reference
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PubMed Identifier
25581339
Citation
Bellamy N, Hochberg M, Tubach F, Martin-Mola E, Awada H, Bombardier C, Hajjaj-Hassouni N, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M. Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis. Arthritis Care Res (Hoboken). 2015 Jul;67(7):972-80. doi: 10.1002/acr.22538.
Results Reference
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Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
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