A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
研究概览
简要总结
Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.
详细描述
Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.
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)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan
- •Patients without any allergies or major systemic or organ diseases
- •Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI
排除标准
- •Other lower lib fractures
- •Pregnancy
- •Extensive degenerative arthritis in hip
- •Severe osteoporosis in the head and/or neck of the femoral bone
- •Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip
- •Stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion
- •Diagnosed with either Stage 4, 5, or 6, of ONFH classification by either radiography, MR, CT scan.
结局指标
主要结局
Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
时间窗: Baseline before procedure/surgery up to follow up 2 years after
Questionaire Scoring
Visual Analogue Scale(VAS)
时间窗: Baseline before procedure/surgery up to follow up 2 years after
Subjective Pain Scoring
Harris Hip Score (HHS)
时间窗: Baseline before procedure/surgery up to follow up 2 years after
Scoring
次要结局
未报告次要终点