ACL ReconstructionNCT06542705
Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
A study testing Arthrex Internal Brace and ACL Reconstruction in people with ACL Reconstruction, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Arthrex Internal Brace and ACL Reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled 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.
- Conditions
- ACL Reconstruction
- Being tested
- Arthrex Internal Brace, ACL Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex Internal BraceDevice
Also called AR-1593-BC
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.
ACL ReconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Internal Brace | Experimental | Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted. Receives: Device: Arthrex Internal Brace; Procedure: ACL Reconstruction |
| Standard ACLR | Active comparator | Patients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted. Receives: Procedure: ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 24 Post-Operation
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 24 Post-Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 Mar 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J. Alaia, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542705
- Sponsor's protocol ID
- 24-00423
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Michael.Alaia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06542705
- Acronym / sponsor ID
- 24-00423
- Conditions
- ACL Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal Brace | Experimental | Device: Arthrex Internal Brace, Procedure: ACL ReconstructionPatients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted. |
| Standard ACLR | Active comparator | Procedure: ACL ReconstructionPatients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrex Internal BraceAlso: AR-1593-BCThe 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. | Device | Internal Brace |
| ACL ReconstructionAll 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. | Procedure or surgery | Internal Brace, Standard ACLR |
Primary outcome
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.
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.
9 secondary outcomes
Pivot Shift Grade
Time frame: Month 12 Post-Operation
Pivot Shift Grade
Time frame: Month 24 Post-Operation
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation
Time frame: Baseline, Month 12 Post-Operation
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation
Time frame: Baseline, Month 24 Post-Operation
Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation
Time frame: Baseline, Month 12 Post-Operation
Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 24 Post-Operation
Time frame: Baseline, Month 24 Post-Operation
Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation
Time frame: Baseline, Month 12 Post-Operation
Change from Baseline in Lysholm Knee Scoring System Score at Month 24 Post-Operation
Time frame: Baseline, Month 24 Post-Operation
Tegner Activity Level Scale
Time frame: Month 24 Post-Operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Michael.Alaia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J. Alaia, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrex Internal Brace and ACL Reconstruction in people with ACL Reconstruction, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangmin Lee (201-835-9117, sangmin.lee3@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side to side difference in laxity as measured by the KT-1000 Arthrometer (time frame: Month 12 Post-Operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.