Clinical trial NCT05923710: Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis
Official title: Comparison of Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis for Proximal ACL Tears: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Keywords: proximal anterior cruciate ligament tear
primary repair
Lateral Extraarticular Tenodesis
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBU Prof. Cemil Tascioglu City Hospital
Study officials:
affiliation: Metin Sabanci Baltalimani Hospital
name: Yasin Guler, Md
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1007/s00167-018-5199-5. Epub 2018 Oct 8.
citation: 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. eCollection 2021 Jan.
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):2562-2569. doi: 10.1016/j.arthro.2016.04.031. Epub 2016 Jun 17.
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. eCollection 2016 Mar.
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.
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.
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.
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.2015.08.010.
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.