跳至主要内容
临床试验/NCT07671729
NCT07671729招募中不适用

A Prospective Randomized Clinical Trial Comparing Quadriceps Tendon and Peroneus Longus Tendon Autografts in Anterior Cruciate Ligament Reconstruction: Clinical, Functional, and Gait Analysis Outcomes

Acibadem University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
International Knee Documentation Committee (IKDC) Subjective Knee Score

研究概览

简要总结

This prospective randomized clinical trial aims to compare quadriceps tendon and peroneus longus tendon autografts in anterior cruciate ligament reconstruction. Patients with anterior cruciate ligament injury undergoing primary reconstruction surgery will be randomly assigned to one of the two graft groups. Clinical examination findings, return-to-sport outcomes, ankle muscle strength, ankle-related functional scores, and gait analysis parameters will be evaluated at 6 months and 12 months postoperatively. The study aims to investigate both knee-related functional outcomes and donor site morbidity associated with graft harvesting techniques.

详细描述

Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures for restoring knee stability and enabling return to sports activities after ACL injury. Various autograft options have been described for ACL reconstruction, including hamstring tendon, bone-patellar tendon-bone, quadriceps tendon, and more recently, peroneus longus tendon grafts. Each graft option has unique biomechanical characteristics, advantages, and potential donor site morbidities.

Quadriceps tendon autografts have gained increasing popularity because of their adequate graft diameter, favorable biomechanical properties, and relatively low donor site complications. Peroneus longus tendon autografts have also emerged as a promising alternative graft source with satisfactory clinical outcomes and sufficient graft size. However, concerns remain regarding donor site morbidity, particularly potential effects on ankle muscle strength and ankle function following peroneus longus tendon harvesting.

This prospective randomized study aims to compare quadriceps tendon and peroneus longus tendon autografts in patients undergoing primary ACL reconstruction. Patients will be randomly assigned into two groups according to graft type. Clinical evaluations, functional knee scores, return-to-sport outcomes, ankle muscle strength assessments, ankle-related functional scores, and gait analysis parameters will be assessed during postoperative follow-up.

Follow-up evaluations will be performed at 6 months and 12 months after surgery. The findings of this study are expected to contribute to graft selection strategies in ACL reconstruction by providing comparative data regarding clinical outcomes, functional recovery, gait characteristics, and donor site morbidity.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with anterior cruciate ligament rupture
  • Patients scheduled for primary anterior cruciate ligament reconstruction
  • Age between 18 and 50 years
  • Ability to provide informed consent
  • Willingness to comply with postoperative rehabilitation and follow-up evaluations

排除标准

  • Previous ligament reconstruction surgery on the affected knee
  • Multi-ligament knee injuries requiring additional ligament reconstruction
  • Severe osteoarthritis of the knee
  • Revision anterior cruciate ligament reconstruction
  • Neuromuscular disorders affecting lower extremity function
  • Active infection
  • Inability to comply with follow-up protocol

结局指标

主要结局

International Knee Documentation Committee (IKDC) Subjective Knee Score

时间窗: 12 months postoperatively

Comparison of postoperative subjective knee function between quadriceps tendon and peroneus longus tendon autograft groups using the International Knee Documentation Committee (IKDC) subjective knee evaluation form.

次要结局

  • Return to Sport Rate(Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.)
  • Ankle Plantar Flexion Strength(6 and 12 months postoperatively)
  • Ankle Dorsiflexion Strength(6 and 12 months postoperatively)
  • Ankle Inversion Strength(6 and 12 months postoperatively)
  • Ankle Eversion Strength(6 and 12 months postoperatively)
  • Ankle Rotational Strength(6 and 12 months postoperatively)
  • Ground Reaction Force(6 and 12 months postoperatively)
  • Force Asymmetry(6 and 12 months postoperatively)
  • Weight Distribution(6 and 12 months postoperatively)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muzaffer Agir

Orthopaedic Surgeon, Department of Orthopaedics and Traumatology

Acibadem University

研究点 (1)

Loading locations...

相似试验