Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

Not Applicable

Completed

• Conditions: ACL Injury; Anterior Cruciate Ligament Rupture
• Interventions: Procedure: Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft; Procedure: Arthroscopic ACL reconstruction with retensioned hamstring autograft

• Registration Number: NCT04677218
• Lead Sponsor: Emre Kocazeybek

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-14
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Third Group	Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft	In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation.
Second Group	Arthroscopic ACL reconstruction with retensioned hamstring autograft	In the second group, the hamstring autograft will be retensioned after tibial fixation.

Primary Outcome Measures

Name	Time	Method
Kt-1000 Stability	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	12.months postoperatively	Flexor and Extansor muscle group of the knee

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology; 🇹🇷 İstanbul, Turkey