Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction
Condition: ACL Injury; Anterior Cruciate Ligament Rupture
MeSH terms: Rupture; Anterior Cruciate Ligament Injuries
Study type: Interventional

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.
    

Intervention name(s): Arthroscopic ACL reconstruction with retensioned hamstring autograft; Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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 .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ACL injury; Adjustable femoral loop; Arthroscopic ACL reconstruction; outcomes