ACL Reconstruction
Conditions
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.
Interventions
DEVICEArthrex Internal Brace
The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
PROCEDUREACL Reconstruction
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side to side difference in laxity as measured by the KT-1000 Arthrometer | Month 12 Post-Operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pivot Shift Grade | Month 12 Post-Operation | 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. |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation | Baseline, 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. |
| Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation | Baseline, 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. |
| Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation | Baseline, 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). |
| Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation | Baseline, 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). |
| Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation | Baseline, 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. |
| Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation | Baseline, 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. |
| Tegner Activity Level Scale | Month 24 Post-Operation | 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. |
Countries
United States
Contacts
CONTACTSangmin Lee
CONTACTKobe Rodney
PRINCIPAL_INVESTIGATORMichael J. Alaia, MD
NYU Langone Health
Outcome results
None listed