Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

NCT ID: NCT05923710

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Primary anterior cruciate ligament repair

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

Group Type ACTIVE_COMPARATOR

Primary anterior cruciate ligament repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

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

Investigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.

Group Type ACTIVE_COMPARATOR

Primary anterior cruciate ligament repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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Primary anterior cruciate ligament repair

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Bulent KARSLIOGLU

Orthopedics and Traumatology specialist,Chief assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasin Guler, Md

Role: PRINCIPAL_INVESTIGATOR

Metin Sabanci Baltalimani Hospital

Locations

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SBU Prof. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 30298414 (View on PubMed)

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.

Reference Type RESULT
PMID: 33532213 (View on PubMed)

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.

Reference Type RESULT
PMID: 27324969 (View on PubMed)

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.

Reference Type RESULT
PMID: 27047983 (View on PubMed)

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.

Reference Type RESULT
PMID: 21331205 (View on PubMed)

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.

Reference Type RESULT
PMID: 27894180 (View on PubMed)

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.

Reference Type RESULT
PMID: 29373290 (View on PubMed)

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.

Reference Type RESULT
PMID: 26542201 (View on PubMed)

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.

Reference Type RESULT
PMID: 11665744 (View on PubMed)

Other Identifiers

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Anterior Cruciate Tear Repair

Identifier Type: -

Identifier Source: org_study_id

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