ACL InjuryNCT06289153
Internal Bracing Following ACL Reconstruction
A study testing Arthrex Internal Brace and ACL Reconstruction in people with ACL Injury, 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 quadriceps graft with and without internal bracing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Injury
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 26 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Who cannot join
- Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
- History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Internal Bracing on Outcomes Following ACL Reconstruction With Quadriceps Tendon: 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 quadriceps graft with and without internal bracing.
Read the detailed description
The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.
- Conditions
- ACL Injury
- Being tested
- Arthrex Internal Brace, ACL Reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex Internal BraceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Internal Brace | Experimental | Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. Receives: Device: Arthrex Internal Brace; Procedure: ACL Reconstruction |
| Standard ACLR | Active comparator | Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. Receives: Procedure: ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: Baseline, Month 6 Post-Operation
Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or 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 Lysholm Knee Scoring System Score at Month 6 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 6 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 Visual Analogue Scale (VAS) - Pain Score at Month 6 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 6 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2025 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Why it stopped: Study not initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillem Gonzalez-Lomas, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289153
- Sponsor's protocol ID
- 23-01182
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Internal Bracing on Outcomes Following ACL Reconstruction With Quadriceps Tendon: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06289153
- Acronym / sponsor ID
- 23-01182
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 1 Mar 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 quadriceps graft with and without internal bracing.
Detailed description
The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- 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. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. |
| Standard ACLR | Active comparator | Procedure: ACL ReconstructionPatients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
Key exclusion criteria (2 listed)
- Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
- History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
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 BraceThe 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. | Procedure or surgery | Internal Brace, Standard ACLR |
Primary outcome
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation
Time frame: Baseline, Month 6 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation
Time frame: Baseline, Month 12 Post-Operation
The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or 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 6 Post-Operation
Time frame: Baseline, Month 6 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 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.
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation
Time frame: Baseline, Month 6 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 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. De-identified participant data will not be available to other researchers.
Related trials for ACL Injury
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Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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ACL Tears
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ACL Tear
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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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. This study is not recruiting at the moment.
Guillem Gonzalez-Lomas, 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 Injury, 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 9 Jan 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation (time frame: Baseline, Month 6 Post-Operation). The study lists 6 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 9 Jan 2026.