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Clinical Trials/NCT05923710
NCT05923710
Completed
Not Applicable

Comparison of Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis for Proximal ACL Tears: A Prospective Study

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 site in 1 country38 target enrollmentStarted: February 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Enrollment
38
Locations
1
Primary Endpoint
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).

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 40 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

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).

Time Frame: 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.

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bulent KARSLIOGLU

Orthopedics and Traumatology specialist,Chief assistant

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study Sites (1)

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