About this trial
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients must be age 14-26 years old.
Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.
Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity
Patients with associated meniscal and chondral pathology (except patients falling into
Disqualifiers
An understanding of the purpose of the study and providing written informed consent.
Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),
Patients who have undergone previous ACL reconstructive surgery.
Patients who are currently pregnant or nursing.
Trial population
patients 14-26 years old with ACL ruptures
Trial design
Cohort
Prospective
Treatments tested in this trial
Fertilized ACL
Procedure/SurgeryFertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.
Treatment groups
Trial outcomes
Primary outcomes
Return to play
Patient will be monitored for return to play at their sport
Biomechanics testing
Patient will undergo hop testing for limb symmetry
Secondary outcomes
MRI findings
At 6 months, all subjects will undergo magnetic resonance imaging (MRI) of the operative extremity to investigate bone healing between groups. Imaging for this time-point is paid for by the grant/sponsor; there is no cost to the subject, and it is NOT submitted to insurance.
Other outcomes
Rerupture
Patients will be asked if they have a rerupture of their graft at 2 years after surgery
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marshall University
Lead sponsor
Arthrex, Inc.
Collaborator