"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.
Patients with osteoarthritis of the knee will be included in a randomized controlled, double-blind study, in which one group of patients will be treated with an infiltration of PRP combined with HA (PRP + HA group), one group of patients will be treated with an infiltration of PRP alone (PRP group), and another group of patients will be treated with an infiltration of HA alone (HA group). They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data. A total of 288 patients will be included, and they will undergo infiltrative treatment after collecting informed consent for study participation and biographical data. All enrolled patients undergo transfusion evaluation and venous whole blood sampling from 30 to 60 mL depending on the patient's hematocrit. From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained. To maintain study blinding, all patients will have their blood drawn but PRP will not be produced for patients randomized into the HA group.Following autologous PRP harvesting and production, patients randomized into the treatment group will undergo single intra-articular infiltration of PRP + HA; patients randomized into the control group 1, will undergo single intra-articular infiltration of PRP; and patients randomized into the control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blindness. They will then undergo an intra-articular infiltration of HA .Patients will be clinically evaluated before the infiltration procedure and at 1-3-6- 12 and 24 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checks during follow-up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
Following autologous PRP harvesting and production, 5 mL of PRP and 40 mg/2 mL of HA will be infiltrated into the knee joint affected by gonarthrosis. The combined procedure will be performed by first infiltrating the hyaluronic acid, and next, leaving the needle inserted into the joint to avoid a second needle insertion, the PRP will be infiltrated, respecting the conditions of sterility. In this way, the two products will not be mixed in the same syringe.
Following autologous PRP harvesting and production, patients randomized into control group 1 will undergo single intra-articular PRP infiltration. Five mL of PRP will be infiltrated into the knee joint affected by gonarthrosis.
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
NOT_YET_RECRUITINGIstituto Ortopedico Rizzoli
Bologna, Italy
RECRUITINGWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Time frame: 12 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Time frame: baseline, 1,3,6 and 24 months
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. (Total score 0-100)
Time frame: baseline, 1,3,6, 12 and 24 months
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Time frame: baseline, 1,3,6, 12 and 24 months
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Patients randomized into control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blinding. They will then undergo intra-articular infiltration of 40 mg/ 2 ml HA into the knee with gonarthrosis.
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Time frame: baseline, 1,3,6, 12 and 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines the following categories: symptoms, stiffness, pain, daily activities, sports and quality of life. Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale
Time frame: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (rest)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10) during rest
Time frame: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (exercise activity)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10) during exercise activity
Time frame: baseline, 1,3,6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Time frame: baseline, 1,3,6, 12 and 24 months
EQ-5D (EuroQoL) Current Health Assessment
The generic health-related quality of life instrument-EQ-5D-allows both a description of health status along 5 dimensions and the evaluation of health or the estimation of a health summary score: the EQ-5D score on a scale where 0 is death and 1 is full health. EQ-5D is useful to evaluate the quality life of the patients. The EQ-5D respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems).
Time frame: baseline, 1,3,6, 12 and 24 months
Tegner Activity Level Scale
Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability and 10 represents a competitive level of sport.
Time frame: baseline, 1,3,6, 12 and 24 months
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Time frame: baseline, 1,3,6, 12 and 24 months
Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial. All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "", "much better", "somewhat better", "no change", "a little worse" ; "much worse"
Time frame: 1,3,6, 12 and 24 months
Effectiveness of the blinding procedure
The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.The patient should choose from the following options: "PRP+HA infiltration," PRP infiltration", "HA infiltration". This question is designed to test the effectiveness of the blinding procedure
Time frame: baseline
Expectations of treatment efficacy
The patient should indicate at baseline what benefits they expect from the treatment. The patient should choose one of the following options: "Full recovery," "definitely better","much better", "somewhat better", "no change"
Time frame: baseline