Clinical trial NCT06769711: The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
Official title: The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: anterior cruciate ligament
peroneus longus tendon
hamstring tendon
snq
tunnel widening
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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,

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 SI (Signal Intensity) value 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 scales and it will be examined whether these data are related to SNQ, SI and tunnel expansion.

Eligibility criteria: 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.
* Diagnosis of advanced osteoporosis.
* ACL injuries that occurred more than 12 months prior to surgery.
* Evidence of unstable meniscal injury on preoperative MRI, which may alter the postoperative rehabilitation process.
* Evidence of unstable meniscal injury on preoperative MRI, which may alter the postoperative rehabilitation process.

Primary outcomes:
measure: Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI
timeFrame: 1 year postoperatively.
measure: Graft-Bone Integration Assessed by Signal Intensity (SI) on MRI
timeFrame: 1 year postoperatively.
measure: Change in Tunnel Volume Assessed by CT
timeFrame: Within 1 week post-surgery and at 1 year post-surgery.
Secondary outcomes:
measure: Knee Laxity Assessed by Clinical Tests
timeFrame: At 1-year follow-up.
measure: Patient-Reported Knee Function and Activity Levels
timeFrame: At 1-year follow-up.
measure: Relationship Between Tunnel Changes and Clinical Outcomes
timeFrame: At 1-year follow-up.
measure: Comparison of Graft Healing and Tunnel Changes Between Groups
timeFrame: 1 year postoperatively.
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University, Orthopedic and Traumatology Department
Study officials:
References: