Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anterior Cruciate Ligament Injuries
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two groups of patients, randomly assignedMasking: Double (Participant, Outcomes Assessor)Masking Description: Participants will not be aware of the group that they will be part of. Assessors before and after surgery will not be aware of patients groupsPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 14 years and 45 years
- Gender
- Both males and females
Description
Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and fu...
Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and function, level of activity and generalised ligamentous laxity are assessed. Femoral and tibial tunnels should be placed in their anatomical location accounting for both the native ACL insertion site and bony landmarks. Two groups will be created, one with patients undergoing ACL reconstruction based on a surgeon's experience and one based on a more individualised approach according to the particular characteristics of each patient separately. In addition, patients in the second group will undergo ACL reconstruction with the use of Computer Assisted System (Navigation). Preoperatively and postoperatively, the patients will be assessed with the KT2000 system, the KOOS (Knee injury and Osteoarthritis Outcome), the Tegner- Lysholm Knee scoring system and the IKDC (International Knee Documentation Committee). Additionally, all patient will be examined for their knee function with the use of a 3D gait analysis system. The follow-up examination will take place 6 and 12 months after the surgery.
Tracking Information
- NCT #
- NCT04366362
- Collaborators
- University of Thessaly
- Investigators
- Study Chair: Michael Hantes, MD University General Hospital of Larissa
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