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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment Arthrex Internal Brace for ACL Reconstruction?

Research shows that using the Arthrex Internal Brace in ACL reconstruction can lead to earlier and more aggressive rehabilitation, which may result in better recovery compared to traditional methods. Additionally, the internal brace technique has been used successfully in various knee ligament injuries, suggesting it is a versatile and effective treatment option. ^{1 2 3 4 5}

How does the internal brace treatment for ACL reconstruction differ from other treatments?

The internal brace treatment for ACL reconstruction is unique because it uses a special suture tape and bone anchors to reinforce the ligament, providing extra stability and allowing for quicker recovery. This approach is different from traditional methods as it aims to strengthen the repaired ligament and reduce the risk of re-injury, especially in active individuals. ^{1 2 3 6 7}

Research Team

Michael Alaia, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

Interventions

• Arthrex Internal Brace

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Anterior Cruciate Ligament Reconstruction and Accelerated Rehabilitation with InternalBrace™ Augmentation in a Professional Footballer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Suture Tape Internal Brace Reinforcement of Soft Tissue Allografts for ACL Reconstruction Using a Porcine Model. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Repair and Augmentation with Internal Brace in the Multiligament Injured Knee. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Rehabilitation and functional outcomes in internally braced and standard ACL reconstructions. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament repair with internal brace augmentation: A systematic review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Knee medial collateral ligament and posteromedial corner anatomic repair with internal bracing. [2022]