Internal Brace for ACL Reconstruction

Overseen By Ivanka Bhambhani

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Osteoarthritis, Chondral injury, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 months

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the healing of the knee's ACL, a key ligament for stability, when reconstructed with a special support called an "internal brace" (Arthrex Internal Brace). Participants will have their ACL repaired either with or without this internal brace to determine which method enhances healing and knee function. It suits individuals aged 18 to 35 who require ACL reconstruction using their own bone-tendon-bone tissue and can adhere to a standard rehab plan. As an unphased trial, this study allows participants to contribute to innovative research that may enhance future ACL reconstruction techniques.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Arthrex Internal Brace is safe for ACL reconstruction?

Studies have shown that the Arthrex Internal Brace used in ACL reconstruction is safe for patients. Research indicates that patients who underwent surgery with this brace are much less likely to require another ACL surgery later, suggesting that the treatment is well-tolerated. One study found the brace's failure rate to be only 1% over five years, which is very low. This indicates that most people do not experience problems with it over time. Overall, the Internal Brace appears to be effective without causing many issues for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Arthrex Internal Brace for ACL reconstruction because it introduces a new support structure to the traditional ACL repair process. Unlike standard ACL reconstruction, where the ligament is replaced or repaired without additional reinforcement, this method integrates an internal brace that acts like a seatbelt, offering extra stability during healing. This can potentially lead to faster recovery times and better long-term outcomes for patients by providing immediate support and protection to the healing ligament.

What evidence suggests that the Arthrex Internal Brace is effective for ACL reconstruction?

In this trial, participants will undergo ACL Reconstruction (ACLR) with or without the Arthrex Internal Brace. Research has shown that using the Arthrex Internal Brace in ACL surgery can be very effective. One study found that this method had a low failure rate of just 1% over five years, indicating strong long-term stability. The Internal Brace also reduces stress on the ACL, supporting better healing of the ligament. Patients in that study demonstrated promising results with improved early healing and function compared to traditional methods. Overall, these findings suggest that the Internal Brace could be a reliable choice for ACL surgery, potentially leading to better outcomes and faster recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Michael Alaia, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

I can follow a standard rehab plan and move my knee without pain during surgery.

I am having ACL reconstruction using a patellar tendon graft.

Exclusion Criteria

My knee or hip arthritis is moderate to severe on X-rays.

I have a severe cartilage injury larger than 2cm2.

I am having or have had a LET procedure along with another surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL reconstruction with or without internal bracing, followed by standard perioperative protocol

12 months

Visits at 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and KT-1000 testing

12 months

Follow-up at 12 months and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Arthrex Internal Brace

How Is the Trial Designed?

Group I: Internal Brace Experimental Treatment 2 Interventions

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.

Group II: Standard ACLR Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The internal brace technique uses strong polyethylene suture tape and knotless bone anchors to enhance ligament repair, allowing for early movement during the healing process.

This method can be applied to various knee ligament injuries, and recent studies indicate that it provides outcomes comparable to traditional ligament reconstruction techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair and Augmentation with Internal Brace in the Multiligament Injured Knee. Dabis, J., Wilson, A.[2019]

A 31-year-old professional footballer successfully underwent a hybrid ACL reconstruction with internal brace augmentation, allowing for a safe and accelerated recovery.

The player returned to full team training in just 146 days post-surgery, demonstrating the effectiveness of this technique and rehabilitation program in meeting performance-based recovery goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction and Accelerated Rehabilitation with InternalBrace™ Augmentation in a Professional Footballer. Stokes, A., Tompos, T., Hopper, GP., et al.[2023]

ACL repair with internal bracing has a failure rate of 10.4% based on a systematic review of 9 studies involving 347 patients, indicating it is a safe treatment option for proximal ACL tears.

Patient-reported outcomes showed high satisfaction, with mean scores above 87% on various scales, suggesting that this technique not only maintains knee stability but also preserves the benefits of the native ligament.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament repair with internal brace augmentation: A systematic review. Wilson, WT., Hopper, GP., Banger, MS., et al.[2022]

Suture tape reinforcement of soft tissue grafts in ACL reconstruction significantly decreased cyclic displacement by 33% and increased ultimate load by 22% compared to non-reinforced grafts, indicating improved stability and strength.

The study, conducted on porcine knees, suggests that using suture tape could enhance the performance of ACL grafts, potentially allowing for earlier rehabilitation and lower failure rates without compromising stiffness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Suture Tape Internal Brace Reinforcement of Soft Tissue Allografts for ACL Reconstruction Using a Porcine Model. Wicks, ED., Stack, J., Rezaie, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10691290/

Outcomes of Anterior Cruciate Ligament Reconstruction ... This study demonstrates encouraging results of suture tape augmentation of autograft ACLR for both hamstring and patellar tendon grafts.

2. arthrex.com arthrex.com/resources/LA1-00055-EN/primary-cruciate-ligament-repair-scientific-update

Primary Cruciate Ligament Repair Scientific Update “This audit provides early functional outcome and failure data that demonstrates the technique of ACL repair with IBLA is comparable with early ...

3. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00202-0/fulltext

Anterior Cruciate Ligament Repair or Reconstruction With ... In our experience, the failure rate after ACL reconstruction with IB is 1% at the 5-year follow-up period. Notably, these results were achieved ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S205977542500464X

InternalBrace behavior at different orientation placements ... The use of InternalBrace showed a decrease in the deformations of the anterior cruciate ligament, mainly when the InternalBrace was applied in the anteromedial ...

5. arthrex.com arthrex.com/knee/acl-repair

ACL Repair Studies reporting outcomes of remnant-preserving ACL surgeries have shown encouraging results and a greater potential for early healing and better functional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10369099/

Reduced Incidence of Revision Anterior Cruciate Ligament ... ACLR with IB resulted in a significantly decreased risk of revision ACLRs while maintaining comparable patient-reported outcomes.

7. arthrex.com arthrex.com/pt/resources/VID1-007122-en-US/reinforcing-outcomes-the-research-pyramid-of-the-internalbrace-technique-in-aclrepisode-1-safety-and-translational-studies

The Research Pyramid of the InternalBrace™ Technique ... Dive into a decade of peer-reviewed scientific literature and proven outcomes of the InternalBrace technique™ in this immersive three-part ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324002020

Anterior Cruciate Ligament Repair or Reconstruction With ... In our experience, the failure rate after ACL reconstruction with IB is 1% at the 5-year follow-up period. Notably, these results were achieved without an ...