跳至主要内容
临床试验/CTRI/2025/07/090642
CTRI/2025/07/090642尚未招募不适用

Evaluation of changes in biomechanical, clinical and functional outcome of donor ankle following ACL reconstruction with peroneus longus tendon autograft.

Elandevan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate changes in the ankle stability of donor ankle using gait analysis and foot pressure analysis in comparison with the contralateral ankle joint.This study will assess the outcome of ankle and foot instability, knee functional outcome and donor site pain following peroneus longus autograft for ACL reconstruction. This study will shed light on whether peroneus longus autograft can be recommended as a primary graft option for ACL reconstruction.

研究概览

简要总结

Patients presenting to Orthopaedics department, All India Institute of Medical Sciences, Mangalagiri, with ACL tear confirmed on MRI planned for ACL reconstruction will be considered for the study. A complete history and detailed physical examination will be done. Informed written consent will be taken before the patients are included in the study. Patients with complete tear of the ACL confirmed by MRI findings will then undergo ACL reconstruction using peroneus longus tendon autograft. The Patient will be assessed for gait analysis and foot pressure parameters of bilateral ankle using DIERS Formetric 4D dynamic gait analysis system prior to the surgery and after surgery at 6 weeks, 3 months, 6 months. The parameters which will be studied include Gait analysis parameters like step length, step time, stride length, stride time, foot rotation, cadence, stance phase, load response, single support, pressuring, swing phase and foot pressure analysis will be done. Foot pressure analysis will be done at regular intervals to see changes in foot pressure. Details of gait analysis and foot pressure analysis will be noted.

Patients will be evaluated preoperatively and postoperatively at 6 weeks, 3months and 6 months interval for ankle and foot pain and the following scores will be recorded, American Orthopaedic Foot and Ankle Society (AOFAS) Ankle and Hindfoot scale and Foot and Ankle Disability Index (FADI). Patient’s  knee pain and functional outcome will be assessed by Tegner Lysholm score. Post surgery the patient will be evaluated for pain at the donor site using the VAS score on day 0, 2nd day, 5th day and 14th day of surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with anterior cruciate ligament injury with or without meniscal tears who will require ACL reconstruction.
  • Patients who are above 18 years of age.

排除标准

  • Preexisting ankle injury or ankle instability.
  • Patients with osteoarthritis of ankle.
  • Patients with inflammatory arthritis like Rheumatoid arthritis, Gout 4) Patients who require revision anterior cruciate ligament reconstruction 5) Patients with multiligamentous injury of the knee.

结局指标

主要结局

To evaluate changes in the ankle stability of donor ankle using gait analysis and foot pressure analysis in comparison with the contralateral ankle joint.This study will assess the outcome of ankle and foot instability, knee functional outcome and donor site pain following peroneus longus autograft for ACL reconstruction. This study will shed light on whether peroneus longus autograft can be recommended as a primary graft option for ACL reconstruction.

时间窗: outcomes will be assessed at post surgery 6 weeks, 3 momths and 6 months

次要结局

  • 1. To evaluate the changes in functional outcome of the foot & ankle using the AOFAS score & FADI index.(2. To evaluate changes in functional outcome of the knee using Tegner Lysholm score)

研究者

发起方
Elandevan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Elandevan

AIIMS Mangalagiri

研究点 (1)

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