Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee: Does it Help? A Clinical and Magnetic Resonance Imaging (MRI) Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
研究概览
简要总结
This study plans to learn more about ways to treat a joint problem in the knee called Juvenile Osteochondritis Dissecans (OCD). The goal of this study is to see if injecting platelet-rich plasma (PRP) into the knee can help knee cartilage heal faster, and will try to determine whether the injections lead to improvements in pain, performance of activities of daily living, improvements is sports activities and overall function and symptoms reduction. The investigators will compare PRP treatment to conservative therapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 10 - 17 inclusive with open physis confirmed by MRI
- •Documented symptomatic stable juvenile osteochondritis dissecans of the knee based on MRI without changes of osteoarthritis and no prior history of knee surgery.
- •The patient must be able to hold still without sedation for approximately 1 hour and must pass MRI screening evaluation for retained metal.
- •Patients with Di Paola stage 1 or 2 lesions
排除标准
- •Patients with polyarticular disease.
- •Patients with blood disorders (Blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin <9g/dL). Only those patients with a positive history of blood disorders will have a Complete Blood Count (CBC) performed a week prior to inclusion in the study.
- •Patients who had intra-articular treatment with steroids within 3 months
- •Patients who are pregnant or nursing at the time of consent.
- •Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
- •Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish)
- •Patients who had previous knee surgery
- •Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
- •Chronic use of NSAID (defined as taking non-steroidal anti-inflammatory drug) regularly every week for the last 6 months), steroids or chemotherapy drugs
- •Treatment with NSAIDs within 15 days prior to randomization in this study
- •Patients with a BMI over
- •Due to the fact that this study utilizes an injection technique which may be inaccurate in obese subjects.
- •Patients with a prolongation of bleeding time, e.g. those receiving anticoagulant drug therapy
- •Patients with a contraindication to MRI including: patients with cardiac pacemaker or non-approved intracranial vascular clip, and those with orthopedic hardware as the resulting artifact can complicate interpretation
- •Patients with acute or chronic renal failure
- •Patients with a previous anaphylactic reaction to gadolinium enhanced MRI.
- •Patients with Di Paola stage 3 or 4 lesions
研究组 & 干预措施
Platelet rich plasma (PRP)
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
干预措施: Platelet rich plasma (PRP) (Drug)
结局指标
主要结局
Greater Cartilage Healing Measured by Glycosaminoglycan Content on dGEMRIC MRI
时间窗: 6 months
Measured by dGEMRIC MRI
次要结局
- Improvement in Pain, Performance and Overall Function: KOOS, 12 Months(12 Months)
- Improvement in Pain, Performance and Overall Function: IKDC(Baseline, 6 months, 12 months)
- Improvement in Pain, Performance and Overall Function: KOOS, Baseline(Baseline)
- Improvement in Pain, Performance and Overall Function: KOOS, 6 Months(6 Months)