Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    60
  • sponsor
    Emre Kocazeybek
Updated on 9 August 2021
autograft
arthroscopy
torn meniscus
acl injuries

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 radiological outcomes of three different techniques of femoral fixation in ACL reconstruction.

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 (https://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 knottless and without 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 1 weeks, 3 weeks, 1 months, 6 months, 12 months postoperatively .The results of last follow-up will be analyzed. To assess knee stability, KT-1000 measurement will be procedured to both extremites in each group and clinical scores ( Tegner Acitivy Scale, Lyhsolm knee score, IKDC ) will be measured.

To evaluate flexor and extansor muscle group around knee, isokinetic tests will be applied to patients in sitting position.The prospective follow-up data and will be analyzed in order to compare clinical outcomes correlate the femoral loop suspension tecnique.

Details
Condition KNEE INJURY, Anterior Cruciate Ligament Tear, Rupture of Anterior Cruciate Ligament, Anterior Cruciate Ligament Rupture, ACL Injury, Anterior Cruciate Ligament Injury, Knee Injuries, acl injuries
Treatment Arthroscopic ACL reconstruction with retensioned hamstring autograft, Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
Clinical Study IdentifierNCT04677218
SponsorEmre Kocazeybek
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

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
Multiligament knee injuries
Patients with Medial or Lateral Colleteral injuries
Patients with previous revision surgeries
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