What is the mechanism of action of this treatment?

The most common treatments for Anterior Cruciate Ligament (ACL) tears include surgical reconstruction using autografts (patient's own tissue) or allografts (donor tissue), and internal brace augmentation. Surgical reconstruction involves replacing the torn ligament with a graft, which provides a scaffold for new tissue growth and restores knee stability. Internal brace augmentation, a newer technique, involves the use of a synthetic brace to reinforce the graft, increasing its load failure capacity and stabilizing it in-situ. This is particularly important for ACL tear patients as it may enhance the initial stability of the reconstruction, potentially leading to a quicker and more reliable return to activity.

What side effects are associated with this type of intervention?

Common treatments for ACL tears, such as ACL reconstruction with bone-tendon-bone autografts, can have side effects including pain, swelling, stiffness, and risk of infection at the surgical site. Internal brace augmentation, which aims to increase load failure and stabilize the graft, may also carry risks such as graft failure, hardware irritation, and potential for re-injury. Patients may experience limited range of motion and require extensive rehabilitation to regain full function.

What prior FDA approvals exist?

There is no specific mention of FDA-approved drugs or treatments directly related to internal brace augmentation for ACL tears in the provided context. However, ACL reconstruction typically involves surgical techniques such as bone-tendon-bone autografts, which may be augmented with internal bracing to increase load failure and stabilize the graft in-situ. This approach is being studied to potentially improve outcomes in ACL reconstruction surgeries.

What other types of research exist?

Promising novel alternatives to Internal Brace Augmentation for ACL tear treatment include: 1) Platelet-Rich Plasma (PRP) therapy, which may enhance healing and reduce recovery time by delivering growth factors directly to the injury site. 2) Stem cell therapy, although currently lacking strong evidence for tendon disorders, shows potential for promoting tissue regeneration and repair. 3) Biologic scaffolds, which can provide a supportive matrix for tissue growth and improve graft integration. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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ACL Reconstruction With/Without Internal Bracing for Anterior Cruciate Ligament Injury

N/A

Waitlist Available

Led By David Trofa, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding an internal brace during ACL surgery helps patients recover faster and have better outcomes. It focuses on young adults and athletes who need strong and stable knees. The brace is supposed to make the new ligament stronger and more stable while it heals. Internal bracing of the anterior cruciate ligament (ACL) reinforces the ligament and encourages natural healing by protecting it during the healing phase and supporting early mobilization.

Who is the study for?

This trial is for patients treated by Columbia University Sports Medicine Service, aged 12 or older, with a first-time ACL injury confirmed by clinical exam and MRI. It's not suitable for those with previous knee surgery, other knee injuries, neuromuscular disorders affecting the leg, anesthesia risks, or who can't/won't follow the study plan.

What is being tested?

The study compares two ways to fix an ACL tear: both use a patient's own bone-tendon-bone graft but one adds internal brace augmentation (suture tape). The goal is to see if this extra support helps people get back to activities faster and improves their experience post-surgery.

What are the potential side effects?

Potential side effects may include pain at the graft site, swelling in the knee joint, stiffness or loss of motion in the knee. There might also be complications from surgery such as infection or issues related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PROMIS Depression CAT at 1 year

Change in PROMIS Depression CAT at 10 years

Change in PROMIS Depression CAT at 2 weeks

+23 more

Secondary study objectives

Change in International Knee Documentation Committee (IKDC) Score at 1 year

Change in International Knee Documentation Committee (IKDC) Score at 10 years

Change in International Knee Documentation Committee (IKDC) Score at 2 weeks

+45 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACL reconstruction with internal brace augmentation (suture tape)Experimental Treatment2 Interventions

This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure.

Group II: ACL reconstruction without internal brace augmentationActive Control2 Interventions

This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anterior Cruciate Ligament (ACL) tears include surgical reconstruction using autografts (patient's own tissue) or allografts (donor tissue), and internal brace augmentation. Surgical reconstruction involves replacing the torn ligament with a graft, which provides a scaffold for new tissue growth and restores knee stability. Internal brace augmentation, a newer technique, involves the use of a synthetic brace to reinforce the graft, increasing its load failure capacity and stabilizing it in-situ. This is particularly important for ACL tear patients as it may enhance the initial stability of the reconstruction, potentially leading to a quicker and more reliable return to activity.