跳至主要内容
临床试验/CTRI/2021/08/036086
CTRI/2021/08/036086已完成不适用

ASSESSMENT OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF SUPRAPATELLAR AND INFRAPATELLAR APPROACHES OF TIBIAL NAILING IN PATIENTS WITH TIBIA SHAFT FRACTURE: A RANDOMIZED CONTROLLED TRIAL

AIIMS BHUABNESWAR1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
To access the functional outcome of tibia shaft fracture comparing the SPA and IPA in tibial intramedullary nailing using the Lysholm knee score.

研究概览

简要总结

Tibia shaft fractures are due to the high-end energytrauma and more common long bone to get fractured, approximately 2% of allfractures in adult. Presently reamed Intramedullary nailing of the tibia withadditional interlocking screws for the axial and rotational stability is preferredfor unstable tibia shaft fracture.

Traditionally,an infrapatellar port between the articular surface of the knee and tibialtubercle, lateral to tibial tubercle is practiced. Thisapproach requires cutting or splitting of the patellar tendon and sometimesthere is transection of theinfrapatellar nerve, a branch of the saphenous nerve during the procedure. Thisiatrogenic damage leads to anterior knee pain in few patients (10 to 80%). Also,due to the quadriceps extensor complex pull, the conical shape of tibialmetaphysis, and hyperflexion positioning intraoperatively, any angulated entry to the tibia during nailing leads tomalalignment and difficulty to maintain reduction for imaging.To overcomethese challenges, a novel entry port in a semi-extended kneeat a flexion of 15-20 degrees was proposed. This new Suprapatellar approach of tibial IntramedullaryInterlocking Nailing (IMILN) allows easy reduction, lesser fluoroscopy time,decreased malalignment, and reduces the anterior knee pain with equivalentfunctional outcome.

There are a few studies thatshow the superiority of Suprapatellar Approach (SPA) vs Infrapatellar Approach (IPA).These are majorly western literature and extensive research on the Indianpopulation is lacking. Hence a study to further declutter in the Indian setupis required.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Isolated tibia shaft fractures
  • Skeletally matured, age >18 years.

排除标准

  • 1 multiple fractures of Ipsilateral limb 2.Refracture of tibia 3.Intra-articular tibia fractures 4.Arthritic knee 5.Open tibia shaft fractures 6.Neuromuscular diseases of lower limb 7.Pathological fractures 8.Any other complications.

结局指标

主要结局

To access the functional outcome of tibia shaft fracture comparing the SPA and IPA in tibial intramedullary nailing using the Lysholm knee score.

时间窗: 3 momnths, 6 months, 12 months

次要结局

  • To access the radiological outcome of tibia shaft fracture in terms of fracture reduction among the groups.

研究者

发起方
AIIMS BHUABNESWAR
申办方类型
Government medical college

研究点 (1)

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