Protocol summary
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Study aim
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The purpose of this study is comparing the effectiveness of intra-articular injection of hyaluronic acid, hydrolyzed collagen, and platelet-rich plasma in reducing pain, improving function, and the level of satisfaction with treatment of knee osteoarthritis.
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Design
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A controlled, parallel-group, double blind, randomized, phase 3 clinical trial on 120 patients. Random allocation software is used for randomization.
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Settings and conduct
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Subjects, interventionist, outcome assessor, statistician and the researcher are all blind to treatment groups allocation; using pre-filled syringes and sealed envelopes. Subjects will be randomly allocated in 3 groups. The study will take place in Modarres hospital, Tehran.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: People aged 40 to 70 years with a BMI between 18 and 30, based on history and physical examination, knee osteoarthritis is diagnosed and confirmed by using knee x-rays (Kellgren-Lawrence grade 2-3) and the duration of symptoms is more than 3 months. Exclusion criteria : History of uncontrolled diabetes, immunodeficiency, and collagen disorders; Use of NSAIDs within 2 days before injection; Pregnancy or breastfeeding; Geneva valgum/varom more than 20 degrees and Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy, active lumbar radiculopathy
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Intervention groups
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Intervention group 1: includes 40 patients who are treated with CHondroGrid made of low molecular weight hydrolyzed collagen.
Intervention group 2: Includes 40 patients who are treated with PRP in three injections with two-week intervals intra-articularly.
Intervention group 3: Includes 40 patients who are treated with HA injection in three injections with two weeks intervals intra-articularly
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Main outcome variables
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Assessment of knee pain and stiffness, assessment of patient's function in daily tasks and degree of patient's satisfaction.
General information
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Reason for update
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With the aim of more accurately and completely determining the exclusion criteria and clarifying the title of the research project and specifying the brand and characteristics of hyaluronic acid used in this research project, an update was made.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130523013442N34
Registration date:
2023-09-23, 1402/07/01
Registration timing:
registered_while_recruiting
Last update:
2024-02-08, 1402/11/19
Update count:
1
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Registration date
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2023-09-23, 1402/07/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-23, 1402/07/01
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Expected recruitment end date
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2024-05-21, 1403/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis
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Public title
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Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People aged 40 to 70 years who are diagnosed with knee osteoarthritis based on history and physical examination.
Duration of symptoms is more than 3 months.
Confirmation of diagnosis using knee x-ray (Kellgren-Lawrence grade 2-3)
The patient's BMI should be between 18 and 30.
Willingness of the patient to participate in the study
Exclusion criteria:
History of immunodeficiency and collagen disorders and uncontrolled diabetes
History or presence of malignant disorders, infection or active wound in the knee area
Recent history of severe knee injury
Autoimmune and platelet disorders
Treatment with anticoagulant and antiplatelet drugs within 10 days before injection
Use of NSAIDs within 2 days before injection
History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection
History of any intra-articular injection of the knee during the last 6 months
Hemoglobin less than 11 g/dL
Platelet count less than 150,000/ml
History of vasovagal shock
Pregnancy or breastfeeding
Geneva valgum/varum more than 20 degrees
Hypersensitivity to hyaluronate
Allergy to bovine proteins, poultry products, eggs and collagen
Hemarthrosis, erythema and psoriatic lesions
Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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in this clinical trial study, 60 patients with a diagnosis of frozen shoulder will be included in the study randomly .For random allocation of individuals in the study groups, the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including two people in in each of the three groups) with a ratio of 1:1:1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with three types of cards which are identified by the letters A (hydrolyzed collagen recipient group), B (PRP recipient group) and C (hyaluronic acid recipient group). Cards will be recorded and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the researcher, the patient, the data analyst and the outcome evaluator are kept blind and are not aware of the intervention performed on each group of patients, and only the final data are assigned to the first, second, and third groups of random numbers.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-10, 1402/06/19
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1402.317
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis of knee
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Assessment of knee pain
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Timepoint
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At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
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Method of measurement
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Visual analogue scale (VAS), WOMAC and Lequesne index questionnaire
2
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Description
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Assessing the patient's performance in daily tasks
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Timepoint
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At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
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Method of measurement
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Using the WOMAC questionnaire
3
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Description
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Assessment of morning stiffness
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Timepoint
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At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
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Method of measurement
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Using the WOMAC and Lequesne index questionnaire
Secondary outcomes
1
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Description
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The degree of patient's satisfaction with the treatment
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Timepoint
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At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
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Method of measurement
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5-items questionnaire
Intervention groups
1
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Description
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Intervention group: includes 40 patients who are treated with CHondroGrid (Bioteck) made of hydrolyzed collagen diluted in 2 cc of normal saline هn three injections with two-week intervals.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Includes 40 patients who are treated with intraarticular injection of 5 cc of PRP in three injections with two-week intervals.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: includes 40 patients who are treated with 2 cc of hyaluronic acid (Hyalgan) with a molecular weight of 500000-730000 daltons in three injections with two-week intervals intra-articularly.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All the data of people participating in this study can be shared after deidentifying people
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When the data will become available and for how long
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The access period starts one year after the results are published
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To whom data/document is available
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Data of this study will be available to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers.
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From where data/document is obtainable
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By sending an email to alin7093@gmail.com
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What processes are involved for a request to access data/document
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The given request should contain information about his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant.
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Comments
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