Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
Anterior Cruciate Ligament Tear
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring Anterior Cruciate Ligament Reconstruction, Platelet-Rich Plasma, Bone Tunnel Widening
Eligibility Criteria
Inclusion Criteria: Age 18-50 years Primary ACL rupture Time from injury to surgery: 4 weeks to 6 months Single ACL rupture (isolated rupture) ACL surgery with one of the participating senior surgeons Informed Consent as documented by signature Exclusion Criteria: Concomitant ligamentous instability/rupture Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact) Requirement for cartilage invasive treatment (debridement accepted) Osteoarthritis at index knee joint Leg axis deviation over 3° valgus or 4° varus Claustrophobia (contra-indication for the MRI) Women who are pregnant or breast feeding or intention to become pregnant during the study Known or suspected non-compliance, drug or alcohol abuse Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ACLr with bone/PrP-composite
ACLr standard
During surgery, the drilled bone debris is collected in a sterile filtered chamber. Then the bone debris is mixed with PrP. After fixation of the graft the composite is inserted into the drilled tunnel at the interface between tendon to bone. The intraarticular aperture sites are sealed by use of fibrin that is previously gathered out of the PrP as well.
No insertion of additional material after ACL graft fixation.