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

30 Participants Needed

Trial Summary

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 data supports the idea that Internal Bracing for ACL Injury is an effective treatment?

The available research shows that Internal Bracing for ACL Injury is effective. In a study of 252 patients, only 0.8% experienced graft failures, and 96% achieved significant improvement in knee function. This suggests that Internal Bracing leads to good patient outcomes and a low failure rate. Additionally, compared to other treatments, Internal Bracing provides similar or better support for knee injuries, allowing for early rehabilitation and strong ligament repair. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Internal Bracing for ACL Injury?

Research shows that using internal bracing with suture tape for ACL reconstruction leads to good patient outcomes, with a low graft failure rate of less than 1% and high satisfaction scores. This technique helps protect the new ligament during healing and allows for early movement, which is beneficial for recovery. ^{1 2 3 4 5}

What safety data exists for internal bracing in ACL injuries?

The safety data for internal bracing in ACL injuries includes a case series of 252 patients, which showed a graft failure rate of less than 1% and acceptable patient outcomes. Additionally, a systematic review provides an overview of the safety and efficacy of ACL repair with internal bracing. The technique is gaining popularity and is considered safe, with evidence suggesting equivalent outcomes to traditional methods. ^{1 4 5 6 7}

Is internal bracing for ACL injuries safe for humans?

Internal bracing for ACL injuries has been shown to be generally safe, with a low graft failure rate of less than 1% in a study of 252 patients. This technique uses suture tape to reinforce the ligament, allowing for early movement and healing. ^{1 4 5 6 7}

Is Internal Bracing a promising treatment for ACL injury?

Yes, Internal Bracing is a promising treatment for ACL injuries. It uses strong suture tape to support the healing ligament, which can help protect it during recovery. This method allows for early movement and has shown encouraging results in both ACL repair and reconstruction, making it a valuable option for knee injuries. ^{1 2 3 4 7}

How does the internal bracing treatment for ACL injury differ from other treatments?

Internal bracing for ACL injury is unique because it uses a high-strength suture tape to reinforce the ligament, providing additional support during the healing process. This method allows for early rehabilitation and aims to reduce the risk of rerupture compared to traditional ACL reconstruction techniques. ^{1 2 3 4 7}

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 quadriceps graft with and without internal bracing.

Research Team

Guillem Gonzalez-Lomas, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

All-Inside Anterior Cruciate Ligament Reconstruction with Suture Tape Augmentation: Button Tie-Over Technique (BTOT). [2022]

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

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

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

Biomechanical Analysis of Internal Bracing for Treatment of Medial Knee Injuries. [2022]

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Primary Anterior Cruciate Ligament Reconstruction with Suture Tape Augmentation: A Case Series of 252 Patients. [2023]

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

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

7. 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]