Clinical trial NCT06542705: Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
Official title: Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Reconstruction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Concomitant Lateral extra-articular tenodesis (LET) procedure
* History of contralateral ACL surgery
* Younger than 18 years of age
* Older than 35 years of age

Primary outcomes:
measure: Side to side difference in laxity as measured by the KT-1000 Arthrometer
timeFrame: Month 12 Post-Operation
measure: Side to side difference in laxity as measured by the KT-1000 Arthrometer
timeFrame: Month 24 Post-Operation
Secondary outcomes:
measure: Pivot Shift Grade
timeFrame: Month 12 Post-Operation
measure: Pivot Shift Grade
timeFrame: Month 24 Post-Operation
measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation
timeFrame: Baseline, Month 24 Post-Operation
measure: Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation
timeFrame: Baseline, Month 24 Post-Operation
measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation
timeFrame: Baseline, Month 12 Post-Operation
measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation
timeFrame: Baseline, Month 24 Post-Operation
measure: Tegner Activity Level Scale
timeFrame: Month 24 Post-Operation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael J. Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References: