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临床试验/CTRI/2024/10/075021
CTRI/2024/10/075021尚未招募4 期

Comparing the Femoral Tunnel Position and Stability following ACL Reconstruction using Outside In V/s Antero Medial Portal Technique-a Randomised Controlled Trial

Dr Sumit Banerjee1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare femoral tunnel position radiologically of patients planned for ACL reconstruction using either outside in vs. anteromedial femoral drilling

研究概览

简要总结

The two most commonly used portal techniques for femoral canal during ACL reconstruction are-Anteromedial(AM) and Outside in(OI).

The utilization of conventional transtibial approaches in initial procedures may pose an increased risk of graft verticality, potentially resulting in issues such as knee instability and a higher likelihood of unfavorable clinical outcomes.

The AM portal technique involves the utilization of an additional AM portal for the individual drilling of the femoral tunnel

RESEARCH QUESTION

Which method provides better femoral tunnel position and stability -between anteromedial and outside in portal techniques?

AIM

To compare portal techniques -outside in vs. anteromedial on basis of femoral tunnel position and stability.

PRIMARY OBJECTIVE

  1. To compare femoral tunnel position radiologically of patients planned for ACL reconstruction using either outside in vs. anteromedial femoral drilling.

SECONDARY OBJECTIVETo compare graft stability in patients undergoing ACL reconstruction using either outside in vs. anteromedial femoral drilling techniques using functional outcome -post op status-clinical tests, scores and radiological aspects.

STUDY PARTICIPANTS (CRITERIA OF SELECTION)

Inclusion criteria

  1. All patients undergoing Primary ACL Reconstruction
  2. All patients that have skeletal maturity.

Exclusion criteria

  1. Patients planned for revision ACL reconstruction
  2. Patients with history of knee trauma who have multi ligament injury

                                                           STUDY PROCEDURE/PROTOCOL

  1. Informed written consent will be taken for using patient data.
  2. Patient satisfying the inclusion and exclusion criteria will be included in our study.
  3. For the patients who have already been treated, all hospital records of the patient including previous admission records, OPD evaluation sheets, clinical and radiological documents and photographs obtained during follow up will be thoroughly assessed.
  4. For ongoing patients, the current hospital records, radiographs, and findings at each

follow-up visit at OPD will be taken into the study.

  1. Patient will be admitted in ward and pre anesthetic checkup will be done and additional investigations as deemed necessary.
  2. The scoring systems-used in the protocol are the standard of care used in the department and data are available in the department records.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing Primary ACL Reconstruction and have skeletal maturity.

排除标准

  • Patients planned for revision ACL reconstruction or having multi ligamentous injury.

结局指标

主要结局

To compare femoral tunnel position radiologically of patients planned for ACL reconstruction using either outside in vs. anteromedial femoral drilling

时间窗: Immediate Pre-Op period,12 weeks,24 weeks

次要结局

  • To compare graft stability in patients undergoing ACL reconstruction using either outside in vs. anteromedial femoral drilling techniques using functional outcome-post op status-clinical tests, scores & radiological aspects(Immediate pre-op period,12 weeks,24 weeks)

研究者

发起方
Dr Sumit Banerjee
申办方类型
Other [individual]
责任方
Principal Investigator
主要研究者

Sagar Setia

ALL INDIA INSTITUTE OF MEDICAL SCIENCES,JODHPUR

研究点 (1)

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