The Best Method for ACL Reconstruction. A Study Comparing Reconstructions of Anterior Cruciate Ligament Using Grafts Taken From Three Different Anatomical Locations at the Knee and Thigh. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in KNEES-ACL score
研究概览
简要总结
The investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Methods using bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of the iliotibial tract graft using a new method of reconstruction.
The purpose is:
- To assess whether one of three different grafts used for reconstruction of the ACL shows superior results compared to the others in relation to mechanical stability and re-rupture rates.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others in subjective patient outcome measures.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering specific symptoms and complications that can be related to donor-site morbidity.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering muscular power, muscle coordination, and function.
详细描述
The purpose of the study is described in the "Brief Summary" section.
Patients scheduled for ACL reconstruction at the Section of Arthroscopic Surgery and Sports Traumatology M51, Department of Orthopedics, Bispebjerg-Frederiksberg Hospital are eligible for this study Eligibility criteria are described in the "Eligibility" section.
The patients are scheduled for ACL surgery at consultation with a doctor from the Section of Arthroscopic Surgery and Sports Traumatology after usual, clinical criteria. The doctor informs the patient about the project, gives the patient the written patient information, and if the patient shows interest in the study, an appointment is scheduled with one of the surgeons involved in the project.
At this appointment the patient is informed about the project by the surgeon. The patients will be granted the reflection time they need before consenting or rejecting.
Before the day of surgery muscle power, muscle coordination and functional tests are performed, and objective tests and PROMs are completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessor is not involved in the surgical procedures. Participants wear long trousers at follow-up procedures to mask surgical incisions.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M
- •Age 18-40 years.
- •Patients able to understand given information in relation to the study and to complete out-come questionnaires.
排除标准
- •Patient activity (sports or work) that excludes one or more of the three methods of surgery, e.g. work predominantly performed kneeling would exclude the use of the BPTBG.
- •Other ligament injuries (except non-surgically treated lesion of MCL - medial collateral ligament) to the same knee or ligament injury (except non-surgically treated lesion of MCL - medial collateral ligament) to the contralateral knee
- •Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.
- •Auto-immune disease that involves lower limb joints or muscles.
- •Local or systemic infection.
- •Actual or previous systemic corticosteroid, chemotherapeutic, or immunosuppressive treatment.
研究组 & 干预措施
ACL-reconstruction hamstrings
ACL reconstruction hamstrings
干预措施: ACL reconstruction hamstrings (Procedure)
ACL-reconstruction patella tendon
ACL reconstruction patella tendon
干预措施: ACL reconstruction patella tendon (Procedure)
ACL-reconstruction iliotibial tract
ACL reconstruction iliotibial tract
干预措施: ACL reconstruction iliotibial tract (Procedure)
结局指标
主要结局
Change in KNEES-ACL score
时间窗: pre-op, 1 year, 2 years
patient-reported outcome measure
次要结局
- Change in graded pivot shift(pre-op, 1 year, 2 years)
- Change in muscle strength and forward lunge ability(pre-op, 1 year, 2 years)
- Change in anterior-posterior stability (quantified by Rolimeter)(pre-op, 1 year, 2 years)
研究者
Lars Konradsen
Senior consultant, clinical professor
Bispebjerg Hospital