THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- KOOS-Pain Score
研究概览
简要总结
The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
详细描述
166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.
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
This is a double-blinded randomized controlled trial with 1:1 allocation.Patient blinding will be provided during the injection treatment.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 65;
- •Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- •Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤
- •[PMID: 2302884 - PMID: 27979409] ;
- •Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam);
- •No clinically significant electrocardiographic alterations (Recently performed ECG).
- •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 who have undergone intra-articular infiltration of another substance within the previous 6 months;
- •Patients undergoing knee surgery within the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients with hematologic diseases (coagulopathies);
- •Patients on anticoagulant-antiaggregant therapy;
- •Patients with 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 which a 60 mL blood draw would be contraindicated;
- •Patients with a recently performed blood test with Hb< 11 g/dl and Platelets < 150,000 plt/mm
- •Previous treatment of patellar dislocation
- •Iwano score of grade 4.
结局指标
主要结局
KOOS-Pain Score
时间窗: 12 months
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
次要结局
- Visual Analogue Scale (VAS)(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- EQ-VAS(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- KOOS-Pain Score(baseline, 2 month, 6 months , 24 months follow-up)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- Tegner Activity Level Scale(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- Objective parameters- Range of Motion(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- IKDC-Subjective Score(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- Objective parameters - Circumferences(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- Patient Acceptable Symptom State (PASS)(baseline, 2 month, 6 months, 12 months , 24 months follow-up)
- The Kujala Anterior Knee Pain Scale (AKPS)(baseline, 2 month, 6 months, 12 months , 24 months follow-up)