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NCT Number: NCT06542705

Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthrex Internal Brace

Device

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.

Other names: AR-1593-BC

ACL reconstruction

Procedure

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.

Primary outcomes

  1. Side to side difference in laxity as measured by the KT-1000 Arthrometer

    Time frame: 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.

  2. Side to side difference in laxity as measured by the KT-1000 Arthrometer

    Time frame: Month 24 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 outcomes

  1. Pivot Shift Grade

    Time frame: 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.

  2. Pivot Shift Grade

    Time frame: Month 24 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.

  3. Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation

    Time frame: 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.

  4. Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation

    Time frame: 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.

  5. Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation

    Time frame: 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).

  6. Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation

    Time frame: 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).

  7. Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation

    Time frame: 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.

  8. Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation

    Time frame: 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.

  9. Tegner Activity Level Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kobe Rodney

CONTACT

[email protected]

347-988-9129

Sangmin Lee

CONTACT

[email protected]

201-835-9117

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 7, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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