Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain Score on the Visual Analog Scale
研究概览
简要总结
The purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular impingement (FAI).
详细描述
This study will determine if PRP treatment of FAI improves (i) patient reported outcome scores and (ii) hip functional stability compared to standard corticosteroid treatment and if PRP treatment of FAI reduces (i) radiographic and (ii) biochemical markers of joint inflammation and cartilage degradation.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic FAI
- •Clinical and radiographic evidence of FAI
- •Patients able to provide consent to study participation
- •Completion of 6 weeks of physical therapy program
排除标准
- •Established Osteoarthritis (Kellgren-Lawrence > 3)
- •Minimum joint space > 2 mm as measured on AP radiograph
- •Hip dysplasia (center edge angle < 20° on AP radiograph)
- •Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes
- •Patients with ongoing infection including HIV and Hepatitis
- •Patient with history of osteomyelitis/septic arthritis
- •Anticoagulation therapy
- •Patients who are pregnant or breast feeding
- •Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis
- •Patients taking immunosuppressant medication
- •Patients with abnormal hematology or serum chemistry lab results
- •Patients receiving injection to treatment knee within 2 months of study enrollment
- •BMI greater than 35 or less than 20
研究组 & 干预措施
platelet-rich plasma
platelet-rich plasma injection into the head-neck junction of the hip joint
干预措施: platelet-rich plasma injection (Drug)
Kenalog 10 mg/mL Injectable Suspension
corticosteroid injection into the head-neck junction of the hip joint
干预措施: Kenalog 10 MG/ML Injectable Suspension (Drug)
结局指标
主要结局
Change From Baseline in Pain Score on the Visual Analog Scale
时间窗: 12 months
VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.(12 months)
- Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS(12 months)
- Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale(12 months)
- Change in Kellgren-Lawrence Classification Scores(12 months)
研究者
Tariq Awan
Assistant Professor in Orthopaedic Surgery
University of Michigan