Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

November 14, 2021 updated by: Emre Kocazeybek

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34156
        • Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: First Group
First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation)
EXPERIMENTAL: Second Group
In the second group, the hamstring autograft will be retensioned after tibial fixation.
Procedure: Arthroscopic ACL reconstruction with retensioned hamstring autograft
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.
ACTIVE_COMPARATOR: Third Group
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
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 .

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emre Kocazeybek

Investigators

  • Principal Investigator: Gokhan Polat, M.D, Istanbul University Istanbul Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

November 15, 2021

Study Completion (ACTUAL)

November 15, 2021

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (ACTUAL)

December 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 14, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67990154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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