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
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.