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临床试验/CTRI/2024/10/075522
CTRI/2024/10/075522尚未招募3 期

Suprapatellar versus Infrapatellar Approach for Intramedullary Nailing of Tibial Diaphyseal Fractures: A Comparative Study

Not Applicable1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Anterior Knee Pain

研究概览

简要总结

Several studies including recent meta-analysis demonstrated that suprapatellar approach may be superior to the infrapatellar approach in many aspects like easier reduction, decreased fluoroscopy time, less anterior knee pain. This study is done to compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Operative Time, Radiographic Alignment, anterior knee pain, fracture union, functional outcomes and complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Skeletally mature patients Tibial Shaft fractures Closed / Gustilo & Anderson Open Type I & II.

排除标准

  • Polytrauma Intraarticular extension of fracture Pathological fracture Patellar fracture Open type III fracture Previous tibial surgery.

结局指标

主要结局

To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Anterior Knee Pain

时间窗: 6 weeks,3 months and 6 months

次要结局

  • To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Fracture union(6 weeks, 3 months, 6 months)
  • To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Radiographic Alignment(Post operative, 6 weeks, 3 months, 6 months)
  • To compare the results of intramedullary nailing of tibial diaphyseal fractures by suprapatellar and infrapatellar approaches in terms of Operative Time(During Surgery)
  • To compare the functional outcomes of the two fixation techniques according to Lysholm Knee Score(6 weeks, 3 months, 6 months)
  • To assess complications among two groups(Post operative,2 weeks, 6 week , 3 months, 6 months)

研究者

发起方
Not Applicable
申办方类型
Other [Not Applicable ]
责任方
Principal Investigator
主要研究者

Arindam Kumar Bhowmik

Department of Orthopaedic Surgery, Jawaharlal Nehru Medical College and Hospital

研究点 (1)

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