Anterior Cruciate Ligament Injuries
Conditions
Keywords
ACL, Anterior, Cruciate, Ligament, Reconstruction, Individualised, Anatomical, Navigation
Brief summary
A randomised prospective control trial comparing the efficiency of a more individualized approach in ACL reconstruction with the help of neuromuscular computer models with traditional ACL reconstruction practices.
Detailed 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 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.
Interventions
PROCEDUREIndividualised ACL reconstruction
ACL reconstruction based on anatomical and functional distinctiveness of each patient separately
PROCEDUREConventional ACL reconstruction
ACL reconstruction based on surgeons experience without taking into account any other patients characteristics
Sponsors
University of Thessaly
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 groups
Intervention model description
Two groups of patients, randomly assigned
Eligibility
Sex/Gender
ALL
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old
Exclusion criteria
* No previous surgery in the knee (except partial meniscectomy), no major systematic pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation | Baseline and 1 year post operation | Participants in two groups will be assessed with KT2000 arthrometer before and after ACL reconstruction regarding knee stability. Additionally knee kinematics and gait analysis before and after the ACL reconstruction will be compared between the two groups in a gait analysis lab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the change from Baseline between the patients of the two groups in KOOS (Knee Injury & Osteoarthritis Outcome) from the baseline until 1 year post operation | Baseline and 1 year post operation | Originally published in 1998 in The Journal of Orthopaedic and Sports Physical Therapy, the Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment. |
| Compare the change from Baseline between the patients of the two groups in IKDC (International Knee Documentation Committee Subjective Knee Form) from the baseline until 1 year post operation. | Baseline and 1 year post operation | the International Knee Documentation Committee Subjective Knee Form (IKDC) was designed to assess patients with a variety of knee disorders including ligamentous and meniscal injuries as well as patellofemoral pain and osteoarthritis. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). |
| Compare the change from Baseline between the patients of the two groups in Tegner Lysholm Knee Scoring Scale from the baseline until 1 year post operation. | Baseline and 1 year post operation | Lysholm Knee Scoring Scale was designed to be used for evaluating outcomes of knee ligament surgery, particularly for symptoms related to instability. The Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). |
| Compare the post operation MRI of the 2 groups | 1 year post operation | Evaluate tunnel positioning in femur and tibia and the graft integration and compare them between the 2 groups. |
Countries
Greece
Contacts
Primary ContactGeorgios Chalatsis, MD
Backup Contactmichael hantes, MD
Outcome results
None listed