Clinical trial NCT04366362: Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction
Official title: Anterior Cruciate Ligament Surgical Reconstruction Based on Individualized Musculoskeletal Models: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL
Anterior
Cruciate
Ligament
Reconstruction
Individualised
Anatomical
Navigation
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2020-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients, randomly assigned
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the change of stability of the operated knee between the two groups from Baseline until 1 year post-operation
timeFrame: Baseline and 1 year post operation
Secondary outcomes:
measure: 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
timeFrame: Baseline and 1 year post operation
measure: 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.
timeFrame: Baseline and 1 year post operation
measure: 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.
timeFrame: Baseline and 1 year post operation
measure: Compare the post operation MRI of the 2 groups
timeFrame: 1 year post operation
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Michael Hantes
Study officials:
affiliation: University General Hospital of Larissa
name: Michael Hantes, MD
role: STUDY_CHAIR
References: