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

March 24, 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

58

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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