Internal Bracing for ACL Injury

Overseen By Michael Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Blood-borne diseases, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate post-operation

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the healing of the Anterior Cruciate Ligament (ACL) after reconstruction surgery using a quadriceps graft, with and without a technique called internal bracing. Internal bracing adds support inside the knee to stabilize it during healing. Participants will receive either the internal brace or not and will complete surveys and undergo knee evaluations at six months and one year post-surgery. The trial seeks individuals with an ACL injury requiring reconstruction, excluding those with other ligament injuries or conditions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance ACL reconstruction outcomes.

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

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Internal Bracing technique is safe for ACL reconstruction?

Research has shown that using internal bracing in ACL (Anterior Cruciate Ligament) reconstruction is safe and promising. This technique uses a strong suture tape to support the ligament, which can enhance knee stability and function. Patients generally tolerate it well.

One study found that internal bracing improved knee function and helped manage pain. Another study noted that this method might lead to better long-term knee stability. Reports of positive outcomes without major side effects suggest it is a safe option for ACL injuries.

For those considering joining a trial for this treatment, current research provides encouraging data on its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about internal bracing for ACL injuries because it offers a novel approach to ACL reconstruction (ACLR). Unlike traditional ACLR, which relies solely on grafts, the internal brace acts as a supportive scaffold, potentially enhancing the stability of the knee and promoting quicker healing. This technique might reduce recovery time and improve outcomes by providing immediate stability post-surgery, which is not typically guaranteed with standard procedures. Additionally, the use of an internal brace could minimize the risk of re-injury, making it an appealing option for active individuals looking to return to sports more confidently and swiftly.

What evidence suggests that the Internal Bracing technique is effective for ACL injury?

Research shows that internal bracing in ACL (Anterior Cruciate Ligament) surgery can enhance knee stability and function. In this trial, participants will be divided into two groups: one will undergo ACL Reconstruction (ACLR) with internal bracing, while the other will have standard ACLR without it. Studies have found that internal bracing reduces the risk of improper ligament healing. Some patients have experienced better long-term stability and function with internal bracing compared to standard ACL surgery. Reports also indicate successful recovery and reduced knee instability with this method. Overall, internal bracing offers strong potential for effective ACL repair. ^{1 3 5 6 7}

Who Is on the Research Team?

Guillem Gonzalez-Lomas, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals who have injured their anterior cruciate ligament (ACL) and are undergoing ACL reconstruction. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

I need surgery for an ACL injury without other knee repairs.

Exclusion Criteria

I have had surgery to repair ligaments, cartilage, or bone alignment.

History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACL Reconstruction (ACLR) with or without internal bracing

Immediate post-operation

6-Month Follow-up

Participants fill out clinical outcome surveys to assess knee function and pain

6 months post-operation

1 visit (in-person)

12-Month Follow-up

Participants undergo MRI evaluation and fill out clinical outcome surveys

12 months post-operation

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Internal Bracing

Trial Overview The study is examining the healing process of the ACL after reconstruction using a quadriceps graft. It compares outcomes with and without the use of an Arthrex Internal Brace, which may provide additional support during healing.

How Is the Trial Designed?

Group I: Internal Brace Experimental Treatment 2 Interventions

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.

Group II: Standard ACLR Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The all-inside ACL reconstruction technique with suture tape augmentation (InternalBrace) is a new method designed to reduce residual laxity and the risk of rerupture, which are common concerns in ACL surgeries.

This technique involves tying the suture tape distally over the TightRope button, providing additional protection to the graft during the healing process, potentially improving outcomes for athletes in pivoting sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-Inside Anterior Cruciate Ligament Reconstruction with Suture Tape Augmentation: Button Tie-Over Technique (BTOT). Waly, AH., ElShafie, HI., Morsy, MG., et al.[2022]

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]

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]

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]

The internal brace technique for repairing femoral-sided medial knee avulsion injuries shows superior performance compared to traditional repair methods, with a significantly higher moment to failure than repair alone, indicating better stability.

While internal bracing did not fully restore the biomechanical properties of an intact knee, it performed similarly to allograft reconstruction, suggesting it is a viable option for enhancing recovery in these types of injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Analysis of Internal Bracing for Treatment of Medial Knee Injuries. Gilmer, BB., Crall, T., DeLong, J., et al.[2022]

In a study of 252 patients who underwent anterior cruciate ligament reconstruction (ACLR) with internal bracing, the graft failure rate was remarkably low at only 0.8%, indicating a safe and effective surgical technique.

Postoperative patient-reported outcomes were positive, with 96% of patients achieving the minimal clinically important difference (MCID) for the Lysholm score, and 84.9% achieving the patient-acceptable symptom state (PASS), demonstrating that internal bracing maintains good functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Anterior Cruciate Ligament Reconstruction with Suture Tape Augmentation: A Case Series of 252 Patients. Daniel, AV., Sheth, CD., Shubert, DJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10749018/

Internal brace augmentation reconstruction versus standard ... We conducted a randomised controlled trial to investigate the clinical efficacy of internal brace technology in ACLR.

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

Anterior Cruciate Ligament Repair or Reconstruction With ... Suture augmentation in anterior cruciate ligament (ACL) reconstruction has the potential to combine improved long-term stability and high functional outcomes ...

3. jorthoptraumatol.springeropen.com jorthoptraumatol.springeropen.com/articles/10.1186/s10195-025-00881-8

Application of internal brace ligament augmentation technique ... Anterior cruciate ligament (ACL) injuries are common and can lead to significant knee instability and an increased risk of long-term ...

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

Anterior Cruciate Ligament Repair or Reconstruction With ... Anterior cruciate ligament (ACL) reconstruction with internal bracing (IB)—and ACL repair with IB when indicated—reduces graft or repair failure ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(24)00536-X/fulltext

Primary Suture Tape Repair and Dynamic Internal Brace ... Promising functional outcomes following anterior cruciate ligament repair with suture augmentation. Knee Surg Sports Traumatol Arthrosc. 2023 ...

6. nature.com nature.com/articles/s41598-025-98491-1

Internal brace augmentation in ACL reconstruction ... This study was to compare the biomechanical outcomes of three ACL graft tibial fixations. Biomechanical testing was performed on 36 fresh ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41003959/

Application of internal brace ligament augmentation ... Conclusions: IBLA appears to be a promising technique for improving functionality, stability, and pain management in anterior cruciate ligament ...