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

Overseen By David P Trofa, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to repair a torn ACL, a knee ligament that stabilizes the joint. Researchers aim to determine if using an extra strengthening tape during surgery helps individuals return to their favorite activities faster and feel better compared to standard ACL reconstruction surgery. Participants will undergo surgery either with this internal brace or without it, followed by a set rehab plan. Individuals who have experienced their first ACL injury and have been evaluated by the Columbia University Sports Medicine Service might be suitable candidates.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance ACL recovery methods for future patients.

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.

What prior data suggests that internal brace augmentation is safe for ACL reconstruction?

Research has shown that using an internal brace with suture tape during ACL (anterior cruciate ligament) surgery is generally well-received by patients. In one study, 90% of patients who received this addition returned to sports, with no cases of graft failure. This suggests the treatment is safe and effective for helping people resume their activities. Another study found that adding suture tape to the ACL graft resulted in stronger outcomes for both hamstring and patellar tendon grafts. While these studies provide encouraging evidence on safety and effectiveness, discussing potential risks and benefits with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACL reconstruction with internal brace augmentation because it offers a potential advancement over the traditional approach. While standard ACL reconstruction uses a bone-tendon-bone (BTB) autograft, this new method incorporates suture tape augmentation to reinforce the graft. This added reinforcement aims to enhance the stability and strength of the reconstructed ligament, potentially leading to better outcomes and faster recovery times for patients. By directly supporting the graft during surgery, this innovative technique could minimize the risk of reinjury and improve long-term knee function.

What evidence suggests that this trial's treatments could be effective for ACL injury?

This trial will compare ACL reconstruction with internal brace augmentation to ACL reconstruction without it. Research has shown that adding an internal brace during ACL surgery can strengthen the repaired ligament. Studies have found that using suture tape (internal bracing) results in better outcomes, with only a 1% chance of the ligament tearing again in the medium term. This reduces the likelihood of the ligament tearing again after surgery. Patients who underwent this type of surgery reported satisfaction with their results even five years later. Overall, using an internal brace appears to make ACL repairs stronger and more durable. ^{1 3 6 7 8}

Who Is on the Research Team?

David P Trofa, MD

Principal Investigator

Associate Professor of Orthopaedic 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

Patients seen by the Columbia University Sports Medicine Service

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

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

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10691290/

Outcomes of Anterior Cruciate Ligament Reconstruction ... This study demonstrates encouraging results of suture tape augmentation of autograft ACLR for both hamstring and patellar tendon grafts.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103404/

Suture tape augmentation in the management of anterior ... This meta-analysis synthesizes prior research to assess the effectiveness of additional SA in treating ACL tears.

3. sciencedirect.com sciencedirect.com/science/article/pii/S221262872400536X

Primary Suture Tape Repair and Dynamic Internal Brace ... Satisfactory patient-reported outcomes at 5 years following primary repair with suture tape augmentation for proximal anterior cruciate ligament tears. Knee ...

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

Anterior Cruciate Ligament Repair or Reconstruction With ... Biomechanical evaluation of suture tape internal brace reinforcement of soft tissue allografts for ACL reconstruction using a porcine model.

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00455-4/fulltext

Arthroscopic Anterior Cruciate Ligament Reconstruction ... showed that suture tape augmentation in hamstring or patellar tendon autografts resulted in a failure rate of 1% at mid-term follow-up. Internal ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2212628725004554

Arthroscopic Anterior Cruciate Ligament Reconstruction ... Daniel and Smith used suture tape augmentation in quadriceps tendon autograft ACL reconstruction and showed a 90% return-to-sport rate, no graft ...

7. 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 ...

8. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(21)00231-0/fulltext

All-Inside Anterior Cruciate Ligament Reconstruction with ... The aim of this article is to describe a modified all-inside ACL reconstruction technique with suture tape augmentation in which the internal ...