Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Postoperative evaluations will be performed regularly at 12 months postoperatively . To assess knee stability, KT-1000 measurement will be applied to both extremities in each group and clinical scores ( lysholm knee score, IKDC ) will be measured. Furthermore, to evaluate flexor and extensor muscle group around knee, isokinetic tests will be applied to patients in sitting position to analyse peak torque and total work done values.

Official Title
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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

Conditions
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ACL Injury, Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Arthroscopic ACL reconstruction with retensioned hamstring autograft
* Procedure: Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ACL Rupture between the ages of 18-55 Patients with isolated + primary ACL rupture only Patients with ACL rupture ± meniscal tear Exclusion Criteria: Patients with Posterior cruciate ligament rupture Multiligamentous knee injuries Patients with Medial or Lateral Collateral injuries Patients with previous revision surgeries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: First Group<br>First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation) | |
| Experimental: Second Group<br>In the second group, the hamstring autograft will be retensioned after tibial fixation. | Procedure: Arthroscopic ACL reconstruction with retensioned hamstring autograft<br>* After diagnostic arthroscopy, an oblique, 5-cm oblique skin incision is made below the joint line over the proximal edge of the pes anserine.Then fascia will be incised the fascia in an L-shaped fashion. After the releasing the distal end of tendons ,tendons will be harvested in their direction via tendon strippers.During the graft preparation phase firstly femoral tunel will be drilled from AM portal with knee flexed to 120 degrees. The drill will be aligned parallel to the tibial plateau and exit through LFC.Then tibial guide wire will be sent from graft incision to the tibial tunel and drilled for desired direction.Once the adjustable loop button is deployed to the graft, it will be pulled through the tunnels and the button is slipped on lateral femoral cortex. Then tibial fixation will be provided with one bioabsorbable screw and staple.After tibial fixation, the femoral loop will be retensioned in group 2 patients.<br>|
| Active Comparator: Third Group<br>In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation. | Procedure: Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft<br>* After the same preparation procedure as in retensioned autograft group, after tibial fixation of graft, femoral loop will be retensioned and knotted in 3. group .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kt-1000 Stability | 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. | 12.months postoperatively | 
| Isokinetic Knee tests | Flexor and Extansor muscle group of the knee | 12.months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC scores | Determining of knee symptoms Function, and activity of daily living | 12.months postoperatively | 
| Tegner-Lysolm score | This is a clinical functional assessment test used for Ligamentous knee disorders. Including 8 parameters . | 12.months postoperatively | 
| Postoperative Range of motion | Knee flexion, Extension will be masured by goniometer | 6.months and 12.months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL injury, Adjustable femoral loop, Arthroscopic ACL reconstruction, outcomes