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临床试验/NCT06222814
NCT06222814招募中不适用

Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Functional results of knee stability and return to normal activity

研究概览

简要总结

This randomized clinical study will be conducted to compare the results of anterior cruciate ligament reconstruction (ACLR) combined with either anterolateral ligament reconstruction using peroneus longus autograft or extra-articular tenodesis (Modified Lemaire) in management of antero-lateral instability of the knee

详细描述

Patients will undergo an anatomic ACLR in a standardized fashion by the same team of surgeons. They are randomly divided into 2 groups either ACLR plus ALL reconstruction or ACLR combined with LET in a 1:1 ratio. There are multiple graft options for ACL-R, but here for the study, the hamstring autograft is harvested following the traditional technique. The graft is measured and bony tunnels are drilled. An anatomical reconstruction technique is used in all cases.

In group A: the surgeon will harvest peroneus longus graft, then sutured to the double bundle hamstring graft. The graft diameters are measured and recorded. The graft is pulled through the femoral tunnel and passed through the tibial tunnel. The single portion of the graft is passed freely through the tibial and femoral tunnels until the quintuple graft portion occupies both tunnels. The graft is then pulled, and an interference screw (Smith & Nephew Endoscopy) is fixed to the femur. The next step is to fix the inferior end of the quintuple graft to the tibia after pre-tensioning. After tibial fixation, the remaining PL is passed through the subcutaneous and ALL tunnels. The ligament is fixed under traction, mild valgus stress, and 30' of flexion 1.5 cm from the joint line into a midpoint between Gerdy's tubercle and the fibular head.

In group B: the surgeon will use a triple STG hamstring (6- strands) tendon graft. The graft diameters are measured and recorded.

Then, LET is performed in a standardized fashion as described in the modified Lemaire technique. LET is fixed with interference screws (Smith & Nephew Endoscopy). Femoral and tibial fixations are performed with bio-absorbable interference screws (Smith & Nephew Endoscopy).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The ACL deficient knee was clinically manifested by physical examination and confirmed by MRI.
  • Age 18-45 years, skeletally mature patient.
  • A positive pivot shift test of at least grade II is required (significant anterolateral instability).

排除标准

  • Multiple ligament injuries or a polytraumatized patient
  • Revision cases.
  • Generalized laxity.
  • Symptomatic articular cartilage defect requiring treatment; Outerbridge > grade II.
  • More than three degrees of varus or valgus malalignment

结局指标

主要结局

Functional results of knee stability and return to normal activity

时间窗: 12 months postoperatively

IKDC (International Knee Documentation Committee) subjective knee evaluation form

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Mohamed Abdelkareem

Assistant lecturer

Sohag University

研究点 (1)

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