Back to resultsPrimary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Primary anterior cruciate ligament repair
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring proximal anterior cruciate ligament tear, primary repair, Lateral Extraarticular Tenodesis
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
Sites / Locations
- SBU Prof. Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Primary anterior cruciate ligament repair
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)
Arm Description
Investigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.
Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05923710
First Posted
March 23, 2023
Last Updated
August 29, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT05923710
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
Keywords
proximal anterior cruciate ligament tear, primary repair, Lateral Extraarticular Tenodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary anterior cruciate ligament repair
Arm Type
Active Comparator
Arm Description
Investigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.
Arm Title
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET)
Arm Type
Active Comparator
Arm Description
Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.
Intervention Type
Procedure
Intervention Name(s)
Primary anterior cruciate ligament repair
Intervention Description
Only arthroscopic primary anterior cruciate ligament repair was performed in patients with proximal anterior cruciate ligament tear.
Intervention Type
Procedure
Intervention Name(s)
Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
Intervention Description
In addition to primary anterior cruciate ligament repair, lateral extraarticular tenodesis was performed using the iliotibial band.
Primary Outcome Measure Information:
Title
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).
Description
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)
Time Frame
24 months
Title
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.
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasin Guler, Md
Organizational Affiliation
Metin Sabanci Baltalimani Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SBU Prof. Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30298414
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.
Results Reference
result
PubMed Identifier
33532213
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.
Results Reference
result
PubMed Identifier
27324969
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.
Results Reference
result
PubMed Identifier
27047983
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.
Results Reference
result
PubMed Identifier
21331205
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.
Results Reference
result
PubMed Identifier
27894180
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.
Results Reference
result
PubMed Identifier
29373290
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.
Results Reference
result
PubMed Identifier
26542201
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.
Results Reference
result
PubMed Identifier
11665744
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.
Results Reference
result
Learn more about this trial
Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis
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