ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Study Overview
=================
Brief Summary
-----------------
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

Detailed Description
-----------------
In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports. This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant. Primary outcome is graft ligamentization assessed in MRI images at 4-6 months

Official Title
-----------------
Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

Conditions
-----------------
Knee Injuries, ACL Tear, ACL Injury, Sports Injury

Intervention / Treatment
-----------------
* Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range) Exclusion Criteria: intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>single bundle technique with the use of bioabsorbable implants | Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction<br>* The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice<br>|
| Active Comparator: Group B<br>single bundle technique with the use of Bio-Intrafix | Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction<br>* The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice<br>|
| Active Comparator: Group C<br>double bundle technique with the use of bioabsorbable implants | Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction<br>* The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice<br>|
| Active Comparator: Group D<br>double bundle technique with the use of Bio-Intrafix | Other: Surgical technique combined with a specific choice of the material for the ligament reconstruction<br>* The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone-graft integration | Bone-graft integration assessed in the MRI | 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical scores | Knee laxity (KT1000, 0 to 5 mm range, higher scores = worse outcome), Objective and Subjective International Knee Documentation Committee (Objective IKDC: 0-100 range, higher scores = better outcomes; Subjective IKDC: A-D range; A = better outcomes) scores, Lysholm score (0-100 range, higher scores = better outcomes) and Tegner Activity Scale (0-10 range, higher scores = higher levels of physical activity/ competitive sport activity) | 4-12 months | 
| Retear | Retear of the reconstructed ACL | Through study completion, an average of 2 years |