ChiCTR-TRC-11001278CompletedPhase 1
新型微创人工全膝关节置换的前瞻性、随机对照临床研究
中山大学临床医学研究 5010 计划项目1 site in 1 country250 target enrollmentStarted: June 1, 2011Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- KSS 评分
Study Overview
Brief Summary
设计新的微创全膝关节置换手术方法及相关器械
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- 统计学家 是
Eligibility Criteria
- Ages
- 55 to 70 (—)
- Sex
- All
Inclusion Criteria
- •1.拟定手术为初次人工膝关节置换术者
- •2.术前心功能Ⅱ级及以上
- •4.洗澡、饮食等自理，无需搀扶或助行器行走
- •5.膝关节畸形内<15°、外翻<20°、屈曲挛缩<15°，屈伸活动度至少 90°
- •6.自愿参加临床试验，愿意积极检查、治疗和术后复查，签署知情同意书
Exclusion Criteria
- •1.肥胖患者 EMI＞30
- •2.需同时对膝关节周围进行其他一些辅助操作，如取内固定物等
- •5.既往有膝关节非关节镜手术者
- •7.低位髌骨者（Blumensaat's line, (2) Insall-Salvati ratio, (3) Modified Insall-Salvati ratio, (4) Blackburne-Peel, (5) Caton-Deschamps 有任何一项符合即可诊断为低位髌骨）
- •8.患有其他慢性疾病或肝肾功能障碍
- •9.依从性差，难以按要求完成检查、治疗和术后复查
Arms & Interventions
A 组
行新型微创全膝关节置换术
B 组
行常规全膝关节置换术
Outcomes
Primary Outcomes
KSS 评分
全膝关节置换术影像学评分
WOMAC 评分
目测类比疼痛评分法
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
碳酸氢钠林格注射液用于全膝关节置换手术的治疗效果研究ChiCTR2200057950自筹60
Unknown
Not Applicable
加速康复模式下氨甲环酸不同应用方式对全膝关节置换术患者的临床效果评价ChiCTR-INR-17010965卫生部行业科研专项基金180
Unknown
Not Applicable
不同下肢神经阻滞复合全麻用于膝关节镜手术的临床效果观察ChiCTR1800018463麻醉科科研经费200
Unknown
Not Applicable
膝骨关节炎进展风险评估模型研究骨关节炎ChiCTR-ROC-17013790北京市科技计划课题：D171100003217001
Not yet recruiting
Not Applicable
Evaluation of Patient Satisfaction Scores and incidence of perioperative complications with adherence to Enhanced Recovery after Surgery (ERAS) protocol in Total Knee replacement surgery in Indian population: A prospective observational StudyCTRI/2025/03/083212Narayana Medcial College50