The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons

June 26, 2026 updated by: Fevzi Gurkan Aslan, Karadeniz Technical University
  1. Comparison of the grafts using Magnetic Resonance Imaging (MR) to determine whether their maturation and bone integration are different,
  2. Comparison of the grafts using Computerized Tomography (CT) to determine whether their effects on the tunnels opened in cruciate ligament reconstruction surgeries are different,
  3. In the event that graft healing and effects on the tunnels differ between grafts, determination of whether these differences are related to patient clinics,

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The project method; Patients who will be operated with 2 different grafts used in anterior cruciate ligament surgeries will be included in 2 different randomized groups of 29 people (hamstring and peroneus groups) determined by obtaining their informed consent before the surgery and then,

  1. The maturation of the grafts will be measured and compared with the SNQ (Signal/Noise quotient) value and the graft-bone integration with the measuring Tendon Bone Healing Grade with the Magnetic Resonance (MR) to be taken at the 1st year controls after the surgery,
  2. Changes in tunnel morphology; The volume of the tunnels will be measured with the Computerized Tomography (CT) imaging method to be taken prospectively within the first week after the surgery date and 1 year after the surgery date and the changes within 1 year will be calculated by comparing them.
  3. In the outpatient clinic follow-ups of both groups; Knee laxity will be obtained with Lachman, Anterior drawer and Pivot shift tests and knee scores and activity levels will be obtained using IKDC, Lysholm, Marx activity scales and it will be examined whether these data are related to SNQ, Tendon Bone Healing Grade and tunnel expansion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Trabzon, Turkey (Türkiye)
        • Karadeniz Technical University, Orthopedic and Traumatology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 18 and 45 years.
  • BMI in the range of 18 to 28.
  • Diagnosed with an anterior cruciate ligament (ACL) injury preoperatively confirmed by MRI.
  • Patients for whom it is deemed appropriate to harvest ipsilateral hamstring tendons or Peroneus Longus tendon for use as a graft.

Exclusion Criteria:

  • History of previous surgery on the affected knee or ankle.
  • Presence of multiple ligament injuries in the affected knee.
  • ACL injuries that occurred more than 12 months prior to surgery.
  • Evidence of unstable meniscal injury on preoperative MRI that may alter the -postoperative rehabilitation protocol.
  • Inability to obtain a graft diameter of at least 9 mm using the isolated graft.
  • Presence of meniscal tears requiring repair.
  • Presence of advanced chondral lesions requiring surgical intervention.
  • Intraoperative detection of multiple ligament injuries.
  • Requirement for additional surgical procedures that would alter the standard rehabilitation protocol.
  • Occurrence of intraoperative surgical complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peroneus Longus Group
Participants who underwent ACL reconstruction using Peroneus Longus tendon graft.
Procedure: Surgical procedure using Peroneus Longus for ACL reconstruction.
Surgical procedure using Peroneus Longus for ACL reconstruction.
Active Comparator: Hamstring Group
Participants who underwent ACL reconstruction using Hamstring tendon graft.
Procedure: Surgical procedure using Hamstring tendons for ACL reconstruction.
Surgical procedure using Hamstring tendons for ACL reconstruction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI
Time Frame: 1 year postoperatively.
Comparison of graft maturation between peroneus longus and hamstring tendon autografts using SNQ values obtained from 1-year postoperative MRI.
1 year postoperatively.
Change in Tunnel Volume Assessed by CT
Time Frame: Within 1 week post-surgery and at 1 year post-surgery.
Comparison of tunnel volume changes between peroneus longus and hamstring tendon autografts by measuring tunnel volume via CT imaging performed within the first week and 1 year after surgery.
Within 1 week post-surgery and at 1 year post-surgery.
Tendon-Bone Healing Assessed by MRI Grading System
Time Frame: 1 year postoperatively.
Comparison of graft-bone integration between peroneus longus and hamstring tendon autografts using MRI Grading System obtained from 1-year postoperative MRI.
1 year postoperatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationship Between Tunnel Changes and Clinical Outcomes
Time Frame: At 1-year follow-up.
Assessment of whether tunnel volume changes correlate with knee function, activity levels, or laxity test results.Statistical correlation analysis between tunnel volume changes and clinical outcomes.
At 1-year follow-up.
Knee Laxity Assessed by Clinical Tests
Time Frame: At 1-year follow-up.
Comparison of knee laxity (Lachman, anterior drawer, and pivot shift tests) between groups and correlation with graft healing (SNQ, Tendon bone healing grade) and tunnel expansion.Clinical grading of laxity based on standard examination protocols.
At 1-year follow-up.
Comparison of Graft Healing and Tunnel Changes Between Groups
Time Frame: 1 year postoperatively.
Evaluation of whether differences in SNQ, Tendon bone healing grade, or tunnel volume changes are specific to patient demographics or clinical characteristics.
1 year postoperatively.
Patient-Reported Knee Function and Activity Levels
Time Frame: At 1-year follow-up.
Comparison of knee function and activity levels between groups using IKDC, Lysholm, and Marx scales and evaluation of correlations with SNQ, Tendon bone healing grade, and tunnel volume changes.Standardized scoring from IKDC, Lysholm, and Marx Activity scales.
At 1-year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24237859510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including demographic, clinical, and radiological outcomes, will be shared. Supporting documents such as the study protocol and statistical analysis plan will also be available.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and will be available for 2 years.

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author, and access will be granted following approval by the study investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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