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Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

Primary Purpose

ACL Injury, Anterior Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Arthroscopic ACL reconstruction with retensioned hamstring autograft
Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
Sponsored by
Emre Kocazeybek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury focused on measuring ACL injury, Adjustable femoral loop, Arthroscopic ACL reconstruction, outcomes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

First Group

Second Group

Third Group

Arm Description

First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation)

In the second group, the hamstring autograft will be retensioned after tibial fixation.

In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation.

Outcomes

Primary Outcome Measures

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.
Isokinetic Knee tests
Flexor and Extansor muscle group of the knee

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2020
Last Updated
November 14, 2021
Sponsor
Emre Kocazeybek
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1. Study Identification

Unique Protocol Identification Number
NCT04677218
Brief Title
Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emre Kocazeybek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Anterior Cruciate Ligament Rupture
Keywords
ACL injury, Adjustable femoral loop, Arthroscopic ACL reconstruction, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Group
Arm Type
No Intervention
Arm Description
First group of fixation will be standar procedure ( without knotted and retensioned the hamstring autograft after tibial fixation)
Arm Title
Second Group
Arm Type
Experimental
Arm Description
In the second group, the hamstring autograft will be retensioned after tibial fixation.
Arm Title
Third Group
Arm Type
Active Comparator
Arm Description
In the third group, the hamstring autograft will be knotted and retensioned after tibial fixation.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic ACL reconstruction with retensioned hamstring autograft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Kt-1000 Stability
Description
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.
Time Frame
12.months postoperatively
Title
Isokinetic Knee tests
Description
Flexor and Extansor muscle group of the knee
Time Frame
12.months postoperatively
Secondary Outcome Measure Information:
Title
IKDC scores
Description
Determining of knee symptoms Function, and activity of daily living
Time Frame
12.months postoperatively
Title
Tegner-Lysolm score
Description
This is a clinical functional assessment test used for Ligamentous knee disorders. Including 8 parameters .
Time Frame
12.months postoperatively
Title
Postoperative Range of motion
Description
Knee flexion, Extension will be masured by goniometer
Time Frame
6.months and 12.months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Polat, M.D
Organizational Affiliation
Istanbul University Istanbul Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
City
İstanbul
ZIP/Postal Code
34156
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27881383
Citation
Choi NH, Yang BS, Victoroff BN. Clinical and Radiological Outcomes After Hamstring Anterior Cruciate Ligament Reconstructions: Comparison Between Fixed-Loop and Adjustable-Loop Cortical Suspension Devices. Am J Sports Med. 2017 Mar;45(4):826-831. doi: 10.1177/0363546516674183. Epub 2016 Nov 25.
Results Reference
background
PubMed Identifier
31072714
Citation
Ahn HW, Seon JK, Song EK, Park CJ, Lim HA. Comparison of Clinical and Radiologic Outcomes and Second-Look Arthroscopic Findings After Anterior Cruciate Ligament Reconstruction Using Fixed and Adjustable Loop Cortical Suspension Devices. Arthroscopy. 2019 Jun;35(6):1736-1742. doi: 10.1016/j.arthro.2019.01.051. Epub 2019 May 6.
Results Reference
background
PubMed Identifier
31147109
Citation
Onggo JR, Nambiar M, Pai V. Fixed- Versus Adjustable-Loop Devices for Femoral Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2019 Aug;35(8):2484-2498. doi: 10.1016/j.arthro.2019.02.029. Epub 2019 May 27.
Results Reference
background
PubMed Identifier
25999126
Citation
Boyle MJ, Vovos TJ, Walker CG, Stabile KJ, Roth JM, Garrett WE Jr. Does adjustable-loop femoral cortical suspension loosen after anterior cruciate ligament reconstruction? A retrospective comparative study. Knee. 2015 Sep;22(4):304-8. doi: 10.1016/j.knee.2015.04.016. Epub 2015 May 19.
Results Reference
background
PubMed Identifier
4028566
Citation
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
Results Reference
background
PubMed Identifier
32247421
Citation
Choi NH, Victoroff BN. Author Reply to "Regarding 'Radiologic and Clinical Outcomes After Hamstring Anterior Cruciate Ligament Reconstruction Using an Adjustable-Loop Cortical Suspension Device With Retensioning and Knot Tying'". Arthroscopy. 2020 Apr;36(4):931-933. doi: 10.1016/j.arthro.2020.01.028. No abstract available.
Results Reference
result
Links:
URL
https://www.random.org/sequences/
Description
Web site used for randomization of participants

Learn more about this trial

Prospective Clinical Results of 3 Different Femoral Fixation in ACL Reconstruction

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