Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- EVA scale for pain measure.
研究概览
简要总结
To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with hyaluronic acid (Hylan G-F 20).
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients> 30 years.
- •Patients who voluntarily express their intention to participate by informed consent.
- •Diagnosis of coxarthrosis who have failed conservative treatments for 6 months
- •Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.
排除标准
- •Treatment with infiltrations 3 months prior to the study
- •Prior treatment with NSAIDs 24h prior to extraction
- •Pre-Surgical Treatment of Hip affects
- •Diabetics
- •Severe liver or kidney disease at the time of extraction
- •Thrombocytopenia (<100,000 platelets / ml) at baseline
- •Anemia (Hb 9 <mg / dl) at baseline
- •Hyaluronic acid Allergy
- •History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy.
- •Acetabular protrusions
- •History of infectious arthritis
- •Excessive deformity (acetabular dysplasia, Perthes)
研究组 & 干预措施
PRP (platelet rich plasma)
37 patients with coxarthrosis are treated with 6ml of PRP (platelet rich plasma), obtained from blood extracted from patients in the 20 minutes prior to infiltration thereof.
For PRP administration:
- The injection should be performed at room temperature.
- The administration should be carried out under aseptic conditions.
- The patient will be placed in the supine position and the administration will be performed by an anterolateral approach.
- The PRP is injected into the synovial space.
干预措施: Platelet rich plasma (Drug)
Hylan G-F 20 (Synvisc-One ®)
37 patients with coxarthrosis are treated with a pre-filled syringe of hyaluronic acid 60mg / 6ml (Synvisc-One ®).
It is necessary to remove synovial fluid before injecting Hylan G-F 20.
- The injection should be performed at room temperature.
- The administration should be carried out under aseptic conditions.
- The patient will be placed in the supine position and the administration will be performed by an anterolateral approach.
- The Hylan G-F 20 is injected into the synovial space.
- After injecting Hylan G-F 20 the patient should stand 5 minutes.
干预措施: Hylan G-F 20 (Drug)
结局指标
主要结局
EVA scale for pain measure.
时间窗: Through study completion, an average of 1 year.
The patient assesses the sensation of pain following a horizontal visual analog scale (EVA) with values between 0 ("no pain") and the value 100 ("excruciating pain"). The records taken are recorded in the medical record of the patient.
Harris Hip Score for pain, function and range of motion measure.
时间窗: Through study completion, an average of 1 year.
It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.
WOMAC questionnaire for pain, stiffness and joint mobility measure.
时间窗: Through study completion, an average of 1 year.
It is a standardized questionnaire, widely used for assessment of both knee and hip osteoarthritis. It consists of five items for assessing pain (range 0-20), two items that assess the stiffness (range 0-8) and 17 items that evaluate the functionality of the joint (range 0-68).
次要结局
未报告次要终点