Comparison of Clinical Results of Adjustable Femoral Loop With Three Different Techniques in Patients Who Underwent Arthroscopic ACL Reconstruction With Hamstring Autograft: A Prospective Randomised Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Kt-1000 Stability
研究概览
简要总结
Anterior cruciate ligament (ACL) tears are one of the most common injuries of the knee. In today's world, due to developing sports industry , the increase in sports traumas of both genders and ages ACL injuries and treatments are given major priority.
The success of anterior cruciate ligament (ACL) reconstruction depends on many factors, including the mechanical properties of the graft, positioning of the proper femoral and tibial tunnel, fixation methods and the postoperative rehabilitation.
The tendon grafts can be fixed on the femoral side using several fixation devices, including cortical suspension devices, cross pins, and interference screws. Femoral fixation via Cortical button in a suture loop provides the highest primary stability, and therefore, has become increasingly popular among orthopaedic surgeons. Adjustable and fixed Femoral cortical loops are commonly used for femoral fixation. In this sudy we aimed to compare clinical and functional outcomes of three different techniques of suspensory femoral fixation in ACL reconstruction.
详细描述
This study has been planned as a prospective randomized clinical trial. We used a completely computer-generated list in order to randomize all participants to receive one of two treatments (www.random.org/sequences/).
Anterior Cruciate Ligament tear diagnosis will be made by physical examination and magnetic resonance imaging. Participants who agree to be enrolled to study will be examined one day prior to surgery. Patients are randomly divided into 3 groups, after tibial fixation of the hamstring autograft, 3 different techniques will be used in the femoral fixation phase.
The first group will be without knotting and retensioning the graft. In the second group, The graft will be retensioned after tibial fixation. In the third group femoral loop will be retensioned and knotted after tibial fixation.
All the surgeries will be performed by the same senior surgeon experienced in sports medicine surgery under regional anesthesia with patient in supine position.
All participants will receive a standard postoperative rehabilitation program starting immediately after surgery with closed chain exercises and quadriceps strengthening and walking. The operated lower extremity won't be placed in a brace and patient allowed for full weight walking with a pair of crutches.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ACL Rupture between the ages of 18-55
- •Patients with isolated + primary ACL rupture only
- •Patients with ACL rupture ± meniscal tear
排除标准
- •Patients with Posterior cruciate ligament rupture
- •Multiligamentous knee injuries
- •Patients with Medial or Lateral Collateral injuries
- •Patients with previous revision surgeries
研究组 & 干预措施
First Group
First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation)
Second Group
In the second group, the hamstring autograft will be retensioned after tibial fixation.
干预措施: Arthroscopic ACL reconstruction with retensioned hamstring autograft (Procedure)
Third Group
In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation.
干预措施: Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft (Procedure)
结局指标
主要结局
Kt-1000 Stability
时间窗: 12.months postoperatively
The KT1000 arthrometer is designed to measure the anterior translation of the tibia while maintaing the femur in position. The results obtained provide an objective diagnostic of the state of the ACL. The healthy leg will be tested first followed by the injured leg. The side-to-side differences will be then evaluated at each force, which allows the diagnosis of the knee laxity.
Isokinetic Knee tests
时间窗: 12.months postoperatively
Flexor and Extansor muscle group of the knee
次要结局
- IKDC scores(12.months postoperatively)
- Tegner-Lysolm score(12.months postoperatively)
- Postoperative Range of motion(6.months and 12.months postoperatively)
研究者
Emre Kocazeybek
Resident in the orthopedics and Traumatology department
Istanbul University