Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05923710
• Other study ID #: Anterior Cruciate Tear Repair
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: August 2023
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Procedure:
• Primary anterior cruciate ligament repair
Only arthroscopic primary anterior cruciate ligament repair was performed in patients with proximal anterior cruciate ligament tear.
• 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.

Locations

Country	Name	City	State
Turkey	SBU Prof. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Abusleme S, Stromback L, Caracciolo G, Zamorano H, Cheyre J, Vergara F, Yanez R. Lateral Extra-articular Tenodesis: A Technique With an Iliotibial Band Strand Without Implants. Arthrosc Tech. 2021 Jan 20;10(1):e85-e89. doi: 10.1016/j.eats.2020.09.029. eCo — View Citation

Achtnich A, Herbst E, Forkel P, Metzlaff S, Sprenker F, Imhoff AB, Petersen W. Acute Proximal Anterior Cruciate Ligament Tears: Outcomes After Arthroscopic Suture Anchor Repair Versus Anatomic Single-Bundle Reconstruction. Arthroscopy. 2016 Dec;32(12):256 — View Citation

Anderson MJ, Browning WM 3rd, Urband CE, Kluczynski MA, Bisson LJ. A Systematic Summary of Systematic Reviews on the Topic of the Anterior Cruciate Ligament. Orthop J Sports Med. 2016 Mar 15;4(3):2325967116634074. doi: 10.1177/2325967116634074. eCollectio — View Citation

Ateschrang A, Schreiner AJ, Ahmad SS, Schroter S, Hirschmann MT, Korner D, Kohl S, Stockle U, Ahrend MD. Improved results of ACL primary repair in one-part tears with intact synovial coverage. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):37-43. doi — View Citation

Csintalan RP, Inacio MC, Funahashi TT. Incidence rate of anterior cruciate ligament reconstructions. Perm J. 2008 Summer;12(3):17-21. doi: 10.7812/TPP/07-140. — View Citation

Di Benedetto P, Di Benedetto E, Fiocchi A, Beltrame A, Causero A. Causes of Failure of Anterior Cruciate Ligament Reconstruction and Revision Surgical Strategies. Knee Surg Relat Res. 2016 Dec 1;28(4):319-324. doi: 10.5792/ksrr.16.007. — View Citation

DiFelice GS, van der List JP. Clinical Outcomes of Arthroscopic Primary Repair of Proximal Anterior Cruciate Ligament Tears Are Maintained at Mid-term Follow-up. Arthroscopy. 2018 Apr;34(4):1085-1093. doi: 10.1016/j.arthro.2017.10.028. Epub 2018 Jan 17. — View Citation

DiFelice GS, Villegas C, Taylor S. Anterior Cruciate Ligament Preservation: Early Results of a Novel Arthroscopic Technique for Suture Anchor Primary Anterior Cruciate Ligament Repair. Arthroscopy. 2015 Nov;31(11):2162-71. doi: 10.1016/j.arthro.2015.08.01 — View Citation

Friden T, Roberts D, Ageberg E, Walden M, Zatterstrom R. Review of knee proprioception and the relation to extremity function after an anterior cruciate ligament rupture. J Orthop Sports Phys Ther. 2001 Oct;31(10):567-76. doi: 10.2519/jospt.2001.31.10.567 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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)	24 months
Primary	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.	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.	24 months