Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

NCT05923710 | Completed DMC

• 1 other identifier: Anterior Cruciate Tear Repair
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Tear

Keywords

proximal anterior cruciate ligament tear; primary repair; Lateral Extraarticular Tenodesis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Primary anterior cruciate ligament repair

ACTIVE COMPARATOR

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

Procedure: Primary anterior cruciate ligament repair; Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band

Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)

ACTIVE COMPARATOR

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; Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band

Interventions

Primary anterior cruciate ligament repair PROCEDURE

Only arthroscopic primary anterior cruciate ligament repair was performed in patients with proximal anterior cruciate ligament tear.

Primary anterior cruciate ligament repair; Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)

Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band PROCEDURE

In addition to primary anterior cruciate ligament repair, lateral extraarticular tenodesis was performed using the iliotibial band.

Primary anterior cruciate ligament repair; Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

SBU Prof. Cemil Tascioglu City Hospital

Istanbul, 34040, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 30298414 RESULT

• 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.

  PMID: 33532213 RESULT

• 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.

  PMID: 27324969 RESULT

• 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.

  PMID: 27047983 RESULT

• 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.

  PMID: 21331205 RESULT

• 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.

  PMID: 27894180 RESULT

• 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.

  PMID: 29373290 RESULT

• 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.

  PMID: 26542201 RESULT

• 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.

  PMID: 11665744 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Linear Energy Transfer

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Energy Transfer; Biophysical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena

Study Officials

• Yasin Guler, Md

  Metin Sabanci Baltalimani Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedics and Traumatology specialist,Chief assistant

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: June 28, 2023
• Study Start: February 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)