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临床试验/CTRI/2024/04/065472
CTRI/2024/04/065472
尚未招募
4 期

Functional Outcome comparing quadriceps tendon autograft with hamstring tendon autograft in anterior cruciate ligament reconstruction: a randomised control trial

Abhay Tyagi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月20日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Abhay Tyagi
入组人数
100
试验地点
1
主要终点
How early patients return to pre injury status

概览

简要总结

Anterior cruciate ligament (ACL) is crucial ligament for knee stability in rotation and forward motion of knee. ACL injury is most common ligament injury in knee occurring in people involved in sporting activities. One of the commonly employed grafts for repair of ACL rupture in current practice involves using hamstring tendon (HT) autograft. Now a days an alternative option for ACL repair is the quadriceps tendon (QT) autograft. This study seeks to compare functional outcome between patients with ACL injury treated with either QT or HT autografts in term of return to pre injury level. Following approval from our institution’s

ethics and research Committee, patients will be randomly assigned to two groups: one receiving QT autograft and the

other HT autograft. Evaluation will occur preoperatively and

postoperatively, utilizing the Lysholm and knee society score and questionnaire at the 1st month, 6th, 9th, and 12th months aiming to prove the hypothesis of using QT graft in ACL reconstruction which may lead to an earlier return to sporting activity compared to a HT graft.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1 18-35 Years 2 Isolated ACL injury 3 Patient active in sporting related activity.

排除标准

  • Arthritic knee.
  • 2 Injury ot any other body part.
  • 3 Patient with multiple comorbidities 4 Patient having inflammatory diseases (Rheumatoid arthritis, Ankylospondolytis) 5 Patient with open wound.

结局指标

主要结局

How early patients return to pre injury status

时间窗: 6th month 9th month 12th month

次要结局

  • Functional outcome in term of knee society score,lysholm score(1 year)

研究者

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

Abhay Tyagi

KIMS, Bhubaneswar, odisha

研究点 (1)

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