Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
"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.
详细描述
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 From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained.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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged 40 to 75 years;
- •Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
- •Unilateral involvement of symptomatology;
- •Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- •Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
- •Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- •Ability and consent of patients to actively participate in clinical follow-up;
- •Signature of informed consent.
排除标准
- •Patients unable to express consent;
- •Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- •Patients undergoing knee surgery in the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with uncontrolled diabetes;
- •Patients with hematological diseases (coagulopathies);
- •Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
- •Patients with uncompensated thyroid metabolic disorders;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Body Mass Index > 35;
- •Patients who have taken NSAIDs in the 3 days prior to blood draw;
- •Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
- •Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm
- •Pregnant and/or fertile women.
研究组 & 干预措施
PRP+HA injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA
干预措施: PRP + HA injection (Combination Product)
PRP injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP
干预措施: PRP injection (Biological)
HA injection
This group of patients randomized into the treatment group, will undergo single intra-articular injection of HA
干预措施: HA injection (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 12 months
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
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 1,3,6 and 24 months)
- IKDC-Subjective Score (Subjective International Knee Documentation Committee)(baseline, 1,3,6, 12 and 24 months)
- Objective parameters- Range of Motion(baseline, 1,3,6, 12 and 24 months)
- Objective parameters - Circumferences(baseline, 1,3,6, 12 and 24 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 1,3,6, 12 and 24 months)
- Visual Analogue Scale (VAS) (rest)(baseline, 1,3,6, 12 and 24 months)
- Visual Analogue Scale (VAS) (exercise activity)(baseline, 1,3,6, 12 and 24 months)
- EuroQol Visual Analogue Scale (EQ-VAS)(baseline, 1,3,6, 12 and 24 months)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 1,3,6, 12 and 24 months)
- Tegner Activity Level Scale(baseline, 1,3,6, 12 and 24 months)
- Patient Acceptable Symptom State (PASS)(baseline, 1,3,6, 12 and 24 months)
- Final treatment opinion(1,3,6, 12 and 24 months)
- Effectiveness of the blinding procedure(baseline)
- Expectations of treatment efficacy(baseline)