Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: Primary anterior cruciate ligament repair; Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band

• Registration Number: NCT05923710
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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.

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 Timeline

• Study Start: 2020-02-01
• Primary Completion: 2021-03-01
• Study Completion: 2023-03-01
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)	Primary anterior cruciate ligament repair	Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.
Primary anterior cruciate ligament repair	Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band	Investigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)	Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band	Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.
Primary anterior cruciate ligament repair	Primary anterior cruciate ligament repair	Investigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.

Primary Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

SBU Prof. Cemil Tascioglu City Hospital; 🇹🇷 Istanbul, Turkey