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AzTrials

Anterior Cruciate Ligament TearNCT05923710

Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis

A study testing Primary anterior cruciate ligament repair and Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band in people with Anterior Cruciate Ligament Tear, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 21 to 40 years
Conditions the study is for
Anterior Cruciate Ligament Tear
What is being tested?
Primary anterior cruciate ligament repair and Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2020to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • SBU Prof. Cemil Tascioglu City Hospital

    Istanbul, 34040

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Primary anterior cruciate ligament repair, Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
Keywords
proximal anterior cruciate ligament tear, primary repair, Lateral Extraarticular Tenodesis
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary anterior cruciate ligament repairProcedure or surgery

    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 bandProcedure or surgery

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

Study groups in NCT05923710
Study groupRoleWhat they receive
Primary anterior cruciate ligament repairActive comparatorInvestigators performed arthroscopic primary repair in 18 patients with proximal ACL tears.
Receives: 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 comparatorInvestigators performed arthroscopic primary repair and lateral extraarticular tenodesis (LET) with iliotibial band in 20 patients with proximal ACL tears.
Receives: Procedure: Primary anterior cruciate ligament repair; Procedure: Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 24 months

  2. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start1 Feb 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923710
Sponsor's protocol ID
Anterior Cruciate Tear Repair
Status last verified
Aug 2023
First submitted
23 Mar 2023
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30298414

  • 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.

    PubMed 33532213

  • 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.

    PubMed 27324969

  • 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.

    PubMed 27047983

  • 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.

    PubMed 21331205

  • 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.

    PubMed 27894180

  • 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.

    PubMed 29373290

  • 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.

    PubMed 26542201

  • 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.

    PubMed 11665744

Questions about this trial

What is this clinical trial studying?

A study testing Primary anterior cruciate ligament repair and Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band in people with Anterior Cruciate Ligament Tear, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923710, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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