Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing

ConditionACL Tear
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorColumbia University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

previous knee surgery

concurrent knee fracture or ligamentous injury on ipsilateral knee

neuromuscular disorder involving lower limb

inability/ unwillingness to adhere to protocol

Trial design

Treatments tested in this trial

  • ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)
  • ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)
  • Standardized Rehabilitation Protocol

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators