跳至主要内容
临床试验/CTRI/2025/02/080953
CTRI/2025/02/080953尚未招募3 期

A prospective randomised study comparing isokinetic strength recovery and return to sports following arthroscopic anterior cruciate ligament reconstruction using peroneus longus graft versus hamstring graft in athletes.

Devbrath Manna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To evaluate the isokinetic strength recovery of knee joint at 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.

研究概览

简要总结

Study Objective-

The study evaluates the isokinetic strength recovery of the knee joint at 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction using different grafts (peroneus longus vs. hamstrings). It aims to evaluate and compare isokinetic strength recovery and return to sports following arthroscopic anterior cruciate ligament reconstruction using peroneus longus versus hamstring autograft.

Study Design-Prospective Randomised Comparative Study.

Study Centre:-The Study Will be conducted at Department Of Sports Medicine, Pt. B. D. Sharma PGIMS, Rohtak.

Study period- From January 2025 to December 2025

Study population-All patients fulfilling inclusion criteria attending Sport Medicine OPD at Pt. B. D. Sharma PGIMS, Rohtak.

Randomisation and Group Allocation-

Patients attending Sports Medicine OPD at Pt. B.D. Sharma, PGIMS, Rohtak with anterior cruciate ligament injuries planning to undergo arthroscopic anterior cruciate ligament reconstruction will be randomly allocated to one of the following two groups using computer-generated random numbers.

Group A- Arthroscopic anterior cruciate ligament reconstruction using peroneus longus tendon autograft (n=25).

Group B- Arthroscopic anterior cruciate ligament reconstruction using hamstring autograft (n=25).

Inclusion-

  1. Athletes with age group between 18-45 years of either sex.

  2. Athletes with symptomatic Anterior Cruciate Ligament injury (Grade 2 and 3) with or without Meniscus injuries.

Exclusion: Strict adherence to exclusion criteria.

Postoperative Protocol-ACL rehabilitation physiotherapy protocol is followed.

Measurements and Assessments-

Isokinetic Strength Testing:

Conducted preoperatively, 4 months, and 6 months postoperatively.

Measurements include knee extension (Ex) and flexion (Flx) at angular velocities of 60°/s and 180°/s using a Biodex dynamometer.

H/Q ratios recorded to assess muscle strength symmetry.

Outcome Evaluation:

Return to sports criteria:H/Q ratio ≥60% at 60°/s.

Less than 10% deficit in quadriceps/hamstring strength compared to the healthy side.

Less than 10% deficit in limb symmetry on single-leg hop testing.

Subjective assessments using Lysholm Knee Score and AOFAS Ankle Score.

Donor Site Morbidity:

Assessed through physical performance and subjective evaluations.

Key Results Expected-

Comparison of functional outcomes (e.g., muscle strength, Return to sports timing) between graft types.

Understanding rehabilitation needs and donor site morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Athletes with symptomatic anterior cruciate ligament injury grade 2 and grade 3 with or without meniscus injuries.

排除标准

  • 1-Patients who do not give consent.
  • 3-Patients with bilateral ACL injury.
  • 4-Patients with multi ligament knee injury.
  • 6-Patients with any other arthropathy affecting knee.
  • 7-Patients with neuromuscular disorders.
  • 8-Patients with any psychiatric disorders.

结局指标

主要结局

To evaluate the isokinetic strength recovery of knee joint at 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.

时间窗: At 4 months and 6 months following arthroscopic anterior cruciate ligament reconstruction.

次要结局

  • 1-To evaluate return to sports.(2-To evaluate the ankle donor site morbidity after harvesting ipsilateral hamstrings tendon.)

研究者

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

Devbrath Manna

Pt. B.D. Sharma PGIMS, Rohtak.

研究点 (1)

Loading locations...

相似试验