NCT03113591已完成不适用
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
Suzhou MicroPort OrthoRecon Co. LTD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation the restoration of hip function at 3 month
研究概览
简要总结
Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.)
- •Subject is a candidate for primary total hip arthroplasty
- •No obvious congenital abnormality in hip joint
- •Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments
排除标准
- •Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- •Overt infection
- •Distant foci of infections
- •Allergy to metals
- •Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray
- •Skeletally immature
- •Neuropathic joints
- •Hepatitis or HIV infection
- •Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- •Pregnant or lactating women
- •Subjects enrolled in another drug or device clinical investigation within 3 month
- •Investigator has judged the subject is not suitable for the study
研究组 & 干预措施
Control group
Active Comparator
undergo common total hip arthroplasty surgery
干预措施: Common total hip arthroplasty (Procedure)
Osteo introducer group
Experimental
undergo minimal invasive total hip arthroplasty surgery
干预措施: Minimum invasive total hip arthroplasty (Procedure)
结局指标
主要结局
Evaluation the restoration of hip function at 3 month
时间窗: 3 month
Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative
次要结局
- Evaluation the restoration of hip function at each time frame(6 week, 3 month, 6 month)
- Laboratory Examinations(3 day, 6 week)
- Visual Analogue Scale(1day, 3day, 2 week)
- Evaluation of X-ray(1day, 6 week, 6 month)
- Barthel Index(1day, 3day, 2 week, 6 week, 3 month, 6 month)
- The use of analgesics(1day, 3day, 2 week, 6 week, 3 month, 6 month)
- Adverse events(up to 6 month)
- Berg Balance Scale(1day, 3day, 2 week, 6 week, 3 month, 6 month)
- Dislocation rate(1day, 3day, 2 week, 6 week, 3 month, 6 month)
研究者
研究点 (1)
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