Anterior Cruciate Ligament RuptureNCT06769711
The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
A study testing Surgical procedure using Peroneus Longus for ACL reconstruction. and Surgical procedure using Hamstring tendons for ACL reconstruction. in people with Anterior Cruciate Ligament Rupture, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Surgical procedure using Peroneus Longus for ACL reconstruction. and Surgical procedure using Hamstring tendons for ACL reconstruction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jun 2026
- 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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Orthopedic and Traumatology Department
Trabzon
About this study
- Comparison of the grafts using Magnetic Resonance Imaging (MR) to determine whether their maturation and bone integration are different,
- Comparison of the grafts using Computerized Tomography (CT) to determine whether their effects on the tunnels opened in cruciate ligament reconstruction surgeries are different,
- In the event that graft healing and effects on the tunnels differ between grafts, determination of whether these differences are related to patient clinics,
Read the 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,
- 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,
- 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.
- 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Surgical procedure using Peroneus Longus for ACL reconstruction., Surgical procedure using Hamstring tendons for ACL reconstruction.
- Keywords
- anterior cruciate ligament, peroneus longus tendon, hamstring tendon, snq, tunnel widening
- 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.
Surgical procedure using Peroneus Longus for ACL reconstruction.Procedure or surgery
Surgical procedure using Peroneus Longus for ACL reconstruction.
Surgical procedure using Hamstring tendons for ACL reconstruction.Procedure or surgery
Surgical procedure using Hamstring tendons for ACL reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Peroneus Longus Group | Experimental | Participants who underwent ACL reconstruction using Peroneus Longus tendon graft. Receives: Procedure: Surgical procedure using Peroneus Longus for ACL reconstruction. |
| Hamstring Group | Active comparator | Participants who underwent ACL reconstruction using Hamstring tendon graft. Receives: Procedure: Surgical procedure using Hamstring tendons for ACL reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI
Comparison of graft maturation between peroneus longus and hamstring tendon autografts using SNQ values obtained from 1-year postoperative MRI.
Measured: 1 year postoperatively.
Tendon-Bone Healing Assessed by MRI Grading System
Comparison of graft-bone integration between peroneus longus and hamstring tendon autografts using MRI Grading System obtained from 1-year postoperative MRI.
Measured: 1 year postoperatively.
Change in Tunnel Volume Assessed by CT
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.
Measured: Within 1 week post-surgery and at 1 year post-surgery.
Secondary outcomes (4)
Knee Laxity Assessed by Clinical Tests
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.
Measured: At 1-year follow-up.
Patient-Reported Knee Function and Activity Levels
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.
Measured: At 1-year follow-up.
Relationship Between Tunnel Changes and Clinical Outcomes
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.
Measured: At 1-year follow-up.
Comparison of Graft Healing and Tunnel Changes Between Groups
Evaluation of whether differences in SNQ, Tendon bone healing grade, or tunnel volume changes are specific to patient demographics or clinical characteristics.
Measured: 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fevzi Gurkan Aslan, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769711
- Sponsor's protocol ID
- 24237859510
- Status last verified
- Jun 2025
- First submitted
- 1 Jan 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
- ClinicalTrials.gov ID
- NCT06769711
- Acronym / sponsor ID
- 24237859510
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament, peroneus longus tendon, hamstring tendon, snq, tunnel widening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Comparison of the grafts using Magnetic Resonance Imaging (MR) to determine whether their maturation and bone integration are different,
- Comparison of the grafts using Computerized Tomography (CT) to determine whether their effects on the tunnels opened in cruciate ligament reconstruction surgeries are different,
- In the event that graft healing and effects on the tunnels differ between grafts, determination of whether these differences are related to patient clinics,
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,
- 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,
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroneus Longus Group | Experimental | Procedure: Surgical procedure using Peroneus Longus for ACL reconstruction.Participants who underwent ACL reconstruction using Peroneus Longus tendon graft. |
| Hamstring Group | Active comparator | Procedure: Surgical procedure using Hamstring tendons for ACL reconstruction.Participants who underwent ACL reconstruction using Hamstring tendon graft. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedure using Peroneus Longus for ACL reconstruction.Surgical procedure using Peroneus Longus for ACL reconstruction. | Procedure or surgery | Peroneus Longus Group |
| Surgical procedure using Hamstring tendons for ACL reconstruction.Surgical procedure using Hamstring tendons for ACL reconstruction. | Procedure or surgery | Hamstring Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Knee Laxity Assessed by Clinical Tests
Time frame: At 1-year follow-up.
Patient-Reported Knee Function and Activity Levels
Time frame: At 1-year follow-up.
Relationship Between Tunnel Changes and Clinical Outcomes
Time frame: At 1-year follow-up.
Comparison of Graft Healing and Tunnel Changes Between Groups
Time frame: 1 year postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure using Peroneus Longus for ACL reconstruction. and Surgical procedure using Hamstring tendons for ACL reconstruction. in people with Anterior Cruciate Ligament Rupture, run by Karadeniz Technical University 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 4 inclusion and 10 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 29 Jun 2026. 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?
Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI (time frame: 1 year postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.