Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
NCT Number: NCT06542705
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL Reconstruction
Interventions: DEVICE: Arthrex Internal Brace|PROCEDURE: ACL Reconstruction
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-09
Locations: NYU Langone Health, New York, New York, 10016, United States

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.

Primary Outcome Measures: Side to side difference in laxity as measured by the KT-1000 Arthrometer, The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear., Month 12 Post-Operation|Side to side difference in laxity as measured by the KT-1000 Arthrometer, The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear., Month 24 Post-Operation
Secondary Outcome Measures: Pivot Shift Grade, The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.

Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament., Month 12 Post-Operation|Pivot Shift Grade, The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee.

Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament., Month 24 Post-Operation|Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation, Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score., Baseline, Month 12 Post-Operation|Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation, Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score., Baseline, Month 24 Post-Operation|Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation, This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)., Baseline, Month 12 Post-Operation|Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation, This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)., Baseline, Month 24 Post-Operation|Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation, The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor., Baseline, Month 12 Post-Operation|Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation, The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor., Baseline, Month 24 Post-Operation|Tegner Activity Level Scale, The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.

A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score \>6 can only be achieved if the person participates in recreational or competitive sport., Month 24 Post-Operation