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Anterior Cruciate Ligament TearNCT05574946

Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Tear, run by Samsun University at 2 sites in Turkey (Türkiye).

Completed

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

Official record
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Trial summary

This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Anterior Cruciate Ligament Tear
What is being tested?
Anterior Cruciate Ligament Reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesTurkey (Türkiye)
Study dates
28 Oct 2022to 20 Nov 2024
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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 45;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
  • Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft

Who cannot join

  • Patients who have not signed informed consent;
  • Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
  • Revision procedures
  • Patients unable to lay still in an MRI or CT scanner
  • Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
  • Patients who had an excessive tibial slope >12 degrees

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Samsun University

    Samsun, Samsun

  • Ahmet E. Okutan

    Samsun

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation

This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

Read the detailed description

This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 80 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 40 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 40 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.

Being tested
Anterior Cruciate Ligament Reconstruction
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.

  • Anterior Cruciate Ligament ReconstructionProcedure or surgery

    Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft

Study groups in NCT05574946
Study groupRoleWhat they receive
All-inside techniqueExperimentalBoth of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used.
Receives: Procedure: Anterior Cruciate Ligament Reconstruction
Complete tibial tunnel techniqueActive comparatorFemoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used.
Receives: Procedure: Anterior Cruciate Ligament Reconstruction

What is being measured

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

  1. Signal to Noise Quotient

    Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation

    Measured: 1 year

Secondary outcomes (4)

  1. Difference in Computed Tomography (CT) imaging of Tunnels

    Femoral and Tibial Tunnel Morphological Changes

    Measured: 1 day, 6 months, 1 year

  2. International Knee Documentation Committee (IKDC)

    Patient reported outcome measures of symptoms, sports activity \& knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)

    Measured: 1 year

  3. Marx Activity Rating Score

    Clinical Outcomes

    Measured: 1 year

  4. Side to side difference in anterior tibial translation

    Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer

    Measured: 6 weeks, 3 months, 6 months, 9 months, 1 year

Timeline

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

  1. First posted12 Oct 2022
  2. Study start28 Oct 2022
  3. Primary completion1 Jul 2024
  4. Study completion20 Nov 2024

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
Single blind
Who is masked
Participant
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05574946
Sponsor's protocol ID
AEOALLACL
Status last verified
Dec 2024
First submitted
6 Oct 2022
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bhimani R, Shahriarirad R, Ranjbar K, Erfani A, Ashkani-Esfahani S. Transportal versus all-inside techniques of anterior cruciate ligament reconstruction: a systematic review. J Orthop Surg Res. 2021 Dec 23;16(1):734. doi: 10.1186/s13018-021-02872-x.

    PubMed 34949188

  • Colombet P, Saffarini M, Bouguennec N. Clinical and Functional Outcomes of Anterior Cruciate Ligament Reconstruction at a Minimum of 2 Years Using Adjustable Suspensory Fixation in Both the Femur and Tibia: A Prospective Study. Orthop J Sports Med. 2018 Oct 22;6(10):2325967118804128. doi: 10.1177/2325967118804128. eCollection 2018 Oct.

    PubMed 30364847

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Cruciate Ligament Reconstruction in people with Anterior Cruciate Ligament Tear, run by Samsun University at 2 sites 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 4 inclusion and 6 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Signal to Noise Quotient (time frame: 1 year). 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 NCT05574946, which also lists 2 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 27 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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