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

Overseen By Christian A Pearsall, BS, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Previous knee surgery, Neuromuscular disorder, others

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the ACL reconstruction 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.

Is ACL reconstruction with internal bracing safe for humans?

Research shows that ACL reconstruction with internal bracing is generally safe, with a low graft failure rate of less than 1% and acceptable patient outcomes. However, incorrect use of knee braces can cause damage, so proper application is important. ^{1 2 3 4 5}

How does ACL reconstruction with internal bracing differ from other treatments for ACL injuries?

ACL reconstruction with internal bracing is unique because it uses a suture tape to protect the graft during healing, allowing for earlier and more aggressive rehabilitation compared to standard ACL reconstruction. This method aims to reduce the risk of rerupture and improve recovery outcomes by providing additional support to the reconstructed ligament. ^{4 5 6 7 8}

What data supports the effectiveness of ACL Reconstruction with or without internal bracing for anterior cruciate ligament injury?

Research shows that a well-structured rehabilitation program after ACL reconstruction, focusing on reducing pain and swelling, regaining motion and strength, and improving balance, can help patients recover effectively without stability issues. Additionally, surgical reconstruction of the ACL often leads to full recovery of function and sports activity in many cases. ^{6 9 10 11 12}

Who Is on the Research Team?

David Trofa, MD

Principal Investigator

Assistant Professor of Orthopedic Surgery

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a first-time ACL injury.

Patients seen by the Columbia University Sports Medicine Service

I am 12 years old or older.

Exclusion Criteria

I have had knee surgery in the past.

Inability or unwillingness to adhere to protocol

I have a muscle or nerve condition affecting my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ACL reconstruction with or without internal brace augmentation

1 day

1 visit (in-person)

Initial Recovery

Participants begin initial recovery and rehabilitation post-surgery

6 weeks

Weekly visits (in-person)

Rehabilitation

Participants continue rehabilitation to regain knee function and strength

3 months

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Periodic visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ACL Reconstruction
• Standardized Rehabilitation Protocol

Trial Overview 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.

How Is the Trial Designed?

Group I: ACL reconstruction with internal brace augmentation (suture tape) Experimental Treatment 2 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 augmentation Active Control 2 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Accelerated and controlled rehabilitation for anterior cruciate ligament (ACL) injuries is increasingly recognized as effective, combining scientific data and clinical experience to guide treatment protocols.

The article discusses key rehabilitation strategies, including exercise, continuous passive motion, proprioceptive training, and knee bracing, which are essential for optimizing recovery in both reconstructed and non-reconstructed ACL knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of anterior cruciate ligament injuries. Halling, AH., Howard, ME., Cawley, PW.[2016]

A study of 70 males after ACL reconstruction showed that following a structured rehabilitation protocol significantly improved thigh muscle circumference and functional recovery compared to those who did not follow the protocol.

Patients who adhered to the rehabilitation protocol had statistically significant better outcomes in muscle size and functional scores at 1, 3, 6, and 12 months post-surgery, indicating the importance of rehabilitation in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of rehabilitation protocol on functional recovery after anterior cruciate ligament reconstruction. Dragicevic-Cvjetkovic, D., Jandric, S., Bijeljac, S., 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]

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]

In a study of 114 adults undergoing ACL reconstruction with hamstring tendon autograft, using a knee brace post-surgery did not show significant benefits over not using one, indicating that brace-free rehabilitation is just as effective.

The research found no meaningful differences in knee function or recovery scores between those who wore a brace and those who did not, suggesting that patients may safely avoid using a knee brace after ACL surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brace-Free Rehabilitation after Isolated Anterior Cruciate Ligament Reconstruction with Hamstring Tendon Autograft Is Not Inferior to Brace-Based Rehabilitation-A Randomised Controlled Trial. Schoepp, C., Ohmann, T., Martin, W., et al.[2023]

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]

Citations

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

Rehabilitation of anterior cruciate ligament injuries. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Use of an extension-assisting brace following anterior cruciate ligament reconstruction. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Anterior cruciate ligament reconstruction and rehabilitation: predictors of functional outcome. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Evidence-based rehabilitation following anterior cruciate ligament reconstruction. [2022]

5. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

The effects of rehabilitation protocol on functional recovery after anterior cruciate ligament reconstruction. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

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

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

Accelerated rehabilitation after anterior cruciate ligament reconstruction. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. New Zealand pubmed.ncbi.nlm.nih.gov

Rehabilitation concerns following anterior cruciate ligament reconstruction. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Brace-Free Rehabilitation after Isolated Anterior Cruciate Ligament Reconstruction with Hamstring Tendon Autograft Is Not Inferior to Brace-Based Rehabilitation-A Randomised Controlled Trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. India pubmed.ncbi.nlm.nih.gov

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