Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
ConditionACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorNYU Langone Health
About this trial
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.
Eligibility criteria
Qualifiers
Patients undergoing ACLR with BTB autograft
Patients ages 18-35, inclusive
Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee
Disqualifiers
Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
History of autoimmune or inflammatory disease
Prior ipsilateral knee ligament surgery or multi-ligament knee injury
Trial design
Treatments tested in this trial
- Arthrex Internal Brace
- ACL Reconstruction
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov