The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons
1 other identifier
interventional
58
1 country
1
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2025
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
March 27, 2026
June 1, 2025
1.4 years
January 1, 2025
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Within 1 week post-surgery and at 1 year post-surgery.
Secondary Outcomes (4)
Knee Laxity Assessed by Clinical Tests
At 1-year follow-up.
Patient-Reported Knee Function and Activity Levels
At 1-year follow-up.
Relationship Between Tunnel Changes and Clinical Outcomes
At 1-year follow-up.
Comparison of Graft Healing and Tunnel Changes Between Groups
1 year postoperatively.
Study Arms (2)
Peroneus Longus Group
EXPERIMENTALParticipants who underwent ACL reconstruction using Peroneus Longus tendon graft.
Hamstring Group
ACTIVE COMPARATORParticipants who underwent ACL reconstruction using Hamstring tendon graft.
Interventions
Surgical procedure using Peroneus Longus for ACL reconstruction.
Surgical procedure using Hamstring tendons for ACL reconstruction.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karadeniz Technical University, Orthopedic and Traumatology Department
Trabzon, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
January 1, 2025
First Posted
January 10, 2025
Study Start
January 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
March 27, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning 6 months after publication and will be available for 2 years.
- 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.
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.