There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.
patients 12 and older
patients seen by the Columbia University Sports Medicine Service
patients diagnosed with a first time ACL injury by clinical exam and MRI
previous knee surgery
concurrent knee fracture or ligamentous injury on ipsilateral knee
neuromuscular disorder involving lower limb
inability/ unwillingness to adhere to protocol
Parallel
ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)
Procedure/SurgeryThe ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.
ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)
Procedure/SurgeryThe ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.
Standardized Rehabilitation Protocol
Other interventionParticipants will undergo a standardized rehabilitation protocol with twice weekly physical therapy
Time to Return to Full Activity or Sports
Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks
Percentage of Participants with Recurrent Knee Instability
Percentage of participants that experience recurrent instability after treatment starts at each time point
Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in PROMIS PF CAT at 6 weeks
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome.
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