BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes (BPTB-HT ACL)
Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in ACL Reconstruction Among Professional Athletes: A Prospective Randomized Controlled Study With Mid-term Follow-up
This prospective randomized controlled study compares outcomes of ACL reconstruction using bone-patellar tendon-bone (BPTB) versus hamstring tendon (HT) autografts in professional athletes.
The primary outcome is isokinetic muscle strength assessment. Secondary outcomes include IKDC score, return to athletic activity, and complication rates. Patients are followed for five years.
研究概览
详细说明
This randomized controlled trial evaluates BPTB versus HT autografts in professional athletes undergoing ACL reconstruction. Patients with isolated ACL rupture were randomly assigned to either graft.
All procedures and rehabilitation protocols were standardized. The primary outcome was isokinetic assessment of quadriceps and hamstring strength using a dynamometer. Secondary outcomes included IKDC score, return to sport, and complications.
Patients were followed for five years to assess functional recovery and long-term outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Cairo Governorate
-
Cairo、Cairo Governorate、埃及
- Kasr Al-Ainy Hospital, Cairo University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Professional athletes actively engaged in competitive sports
- Age between 18 and 35 years
- Primary isolated anterior cruciate ligament (ACL) rupture confirmed clinically and by MRI
- Indicated for arthroscopic ACL reconstruction
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Multiligamentous knee injuries
- Previous ACL reconstruction on the affected knee
- Lower limb malalignment
- Advanced chondral lesions requiring additional surgical procedures
- Associated fractures around the knee
- Inability to comply with follow-up protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BPTB Group
Participants undergoing ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft.
|
Arthroscopic anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft with interference screw fixation.
|
|
有源比较器：Hamstring Group
Participants undergoing ACL reconstruction using hamstring tendon autograft (semitendinosus and gracilis).
|
Arthroscopic anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon autograft with appropriate fixation technique.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Isokinetic Quadriceps and Hamstring Muscle Strength
大体时间：12 months postoperatively
|
Isokinetic dynamometric assessment of quadriceps and hamstring muscle strength expressed as peak torque percentage relative to the contralateral limb using a standardized testing protocol.
|
12 months postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score
大体时间：12 months postoperatively
|
Patient-reported functional outcome measured using the IKDC subjective knee evaluation form.
|
12 months postoperatively
|
|
Time to Return to Athletic Activity
大体时间：Up to 12 months postoperatively
|
Time required for patients to return to pre-injury level of athletic activity.
|
Up to 12 months postoperatively
|
|
Postoperative Complications
大体时间：Up to 60 months postoperatively
|
Incidence of complications including infection, anterior knee pain, extension lag, stiffness, and graft re-rupture.
|
Up to 60 months postoperatively
|
|
Knee function using KOOS score
大体时间：60 months postoperatively
|
Patient-reported outcomes assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), including subscales:
Scores reported on a 0-100 scale (higher scores indicate better function). |
60 months postoperatively
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- N-360-2017
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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