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临床试验/CTRI/2024/09/073758
CTRI/2024/09/073758已完成4 期

Comparison of Functional Outcome of Central Soft Tissue Quadriceps Tendon Graft versus Quadrupled Hamstring Tendon Graft for Arthroscopic Anterior Cruciate Ligament Reconstruction- A Prospective Randomized Control Trial

Aswin S1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年9月17日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
To compare Functional outcomes in ACL Reconstruction using, 1. Lysholm knee score

研究概览

简要总结

Consent will be obtained from eligible participants of this study based on the above mentioned inclusion and exclusion criteria. Demographic information, anthropometric measurements will be collected from all participants. Blood investigations will be done for all participants. Intra operative obtained graft measurements will be recorded. Post operatively all patients of both the group will be following the standardized same ACL protocol physiotherapy . Post operatively patient of the both groups will be followed up at specified interval mentioned above and functional outcome measurements will be recorded.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with Isolated Anterior cruciate ligament tear.

排除标准

  • Multi-ligamentous injury
  • Revision Anterior Cruciate Ligament Reconstruction surgery
  • Associated Ipsilateral Limb Fractures where Anterior Cruciate Ligament Reconstruction planned.

结局指标

主要结局

To compare Functional outcomes in ACL Reconstruction using, 1. Lysholm knee score

时间窗: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

2. IKDC-SKF( International Knee Documentation Committee - Subjective Knee Evaluation Form) SCORE

时间窗: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

3.Tegner activity scale

时间窗: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

4. ACL-RSI ( Anterior Cruciate Ligament-Return to Sport after Injury) Score

时间窗: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

5. Passive Knee Range of Movements

时间窗: Post Surgical intervention followed up at 1st month, 3rd month, 5th month, Return to preinjury level ( at which specified month)

次要结局

  • To assess these factors post operatively(1. VAS Score)

研究者

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

Aswin S

SRM Medical College Hospital and Research Centre

研究点 (1)

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