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Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)
Overall Status
Completed
CT.gov ID
NCT05923710
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
36.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aimed to compare the clinical results of primary repairs and Lateral Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL tears.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Primary anterior cruciate ligament repair
  • Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
 N/A

Detailed Description

The investigators aimed to compare the clinical results of primary repairs and Lateral Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL tears.The aim of this study was to determine the potential for improvement with the primary repair of acute ACL tears with the proximal tear, which may be an important advance for improvements in proprioception and preservation of natural kinematics.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis for Proximal ACL Tears: A Prospective Study
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Primary anterior cruciate ligament repair

Investigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.

Procedure: Primary anterior cruciate ligament repair
Only arthroscopic primary anterior cruciate ligament repair was performed in patients with proximal anterior cruciate ligament tear.
Active Comparator: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)

Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.

Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
In addition to primary anterior cruciate ligament repair, lateral extraarticular tenodesis was performed using the iliotibial band.

Outcome Measures

Primary Outcome Measures

  1. Comparison of functional outcomes between two groups of patients who underwent ACL repair surgery with or without lateral extraarticular tenodesis (LET) with International Knee Documentation Committee (IKDC). [24 months]

    The outcomes were evaluated using various measures, including the International Knee Documentation Committee (IKDC). The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

  2. Comparison of functional outcomes between two groups of patients who underwent ACL repair surgery with or without lateral extraarticular tenodesis (LET) with Tegner-Lysholm scoring system. [24 months]

    The outcomes were evaluated using various measures, including theTegner-Lysholm scoring system. The Tegner Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • patients who underwent surgery within the first 3 weeks after injury

  • between the ages of 21-40 years,

  • attended regular follow-up visits,

  • Sherman type 1 proximal ACL tear with relatively preserved synovial sheath

  • Sufficient tissue length for re-stretching.

Exclusion Criteria:

  • torn ACL in the mid and distal region,

  • torn synovial sheath,

  • inability to undergo intrasubstance suturing,

  • poor tissue quality with retraction,

  • multiple ligament injuries and accompanying intra-knee pathologies (meniscal damage, chondral damage),

  • previous knee surgery,

  • rheumatologic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 SBU Prof. Cemil Tascioglu City Hospital Istanbul Turkey 34040

Sponsors and Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Principal Investigator: Yasin Guler, Md, Metin Sabanci Baltalimani Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bulent KARSLIOGLU, Orthopedics and Traumatology specialist,Chief assistant, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
ClinicalTrials.gov Identifier:
NCT05923710
Other Study ID Numbers:
  • Anterior Cruciate Tear Repair
First Posted:
Jun 28, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bulent KARSLIOGLU, Orthopedics and Traumatology specialist,Chief assistant, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
proximal anterior cruciate ligament tear
primary repair
Lateral Extraarticular Tenodesis
Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Jun 28, 2023