Anterior Cruciate Ligament Rupture
Conditions
Keywords
anterior cruciate ligament, peroneus longus tendon, hamstring tendon, snq, tunnel widening
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 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.
Interventions
PROCEDURESurgical procedure using Peroneus Longus for ACL reconstruction.
Surgical procedure using Peroneus Longus for ACL reconstruction.
PROCEDURESurgical procedure using Hamstring tendons for ACL reconstruction.
Surgical procedure using Hamstring tendons for ACL reconstruction.
Sponsors
Karadeniz Technical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the surgical interventions, blinding of participants and surgeons was not feasible. However, outcome assessors were blinded to group allocation using anonymized imaging data.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft Maturation Assessed by Signal-to-Noise Quotient (SNQ) on MRI | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Laxity Assessed by Clinical Tests | 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. |
| Patient-Reported Knee Function and Activity Levels | 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. |
| Relationship Between Tunnel Changes and Clinical Outcomes | 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. |
| Comparison of Graft Healing and Tunnel Changes Between Groups | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed