Knee Braces for ACL Injury

Overseen By Carla M Edwards, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Age, Prior knee surgery, Others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee brace, the Graymont X ERIS Knee Splint, to determine if it aids recovery after ACL surgery. The main goal is to assess whether this brace improves knee movement compared to a standard knee brace (also known as a Hinged Knee Brace or Knee Immobilizer). The trial also examines whether it reduces the need for additional treatments like physical therapy or injections. Participants should have undergone recent ACL surgery without other major knee repairs, such as meniscus repair, and must be able to attend follow-up clinic visits. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery options for future patients.

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

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

What prior data suggests that these knee braces are safe for postoperative ACL reconstruction?

Research has shown that the Graymont X ERIS Knee Splint is currently being tested for effectiveness after ACL surgery. Unfortunately, past studies do not provide specific information about the safety of this knee splint. However, knee braces are generally safe, as they are non-invasive and rarely cause major side effects.

This trial is in a phase labeled "Not Applicable," likely indicating the collection of early information. As a result, detailed safety data may not yet be available. Nonetheless, knee braces are typically considered safe. It is important to consult a doctor to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Graymont X ERIS Knee Splint because it offers a potentially more advanced approach to ACL injury recovery compared to standard hinged knee braces. Unlike traditional braces that simply stabilize the knee, the Graymont X ERIS incorporates degree splinting, which may provide more precise support and allow for better alignment and movement during rehabilitation. This innovative design could lead to improved recovery outcomes and faster return to normal activities for patients with ACL injuries.

What evidence suggests that these knee braces are effective for ACL injury recovery?

Research has shown that knee braces can protect healing tissues and may prevent reinjury after ACL (anterior cruciate ligament) surgery. Some studies suggest that wearing a brace can improve knee function and comfort. However, the differences in outcomes between brace users and non-users are not always significant. In this trial, participants will be randomized to receive either the Graymont X ERIS Knee Splint or a standard hinged knee brace. The Graymont X ERIS Knee Splint is designed to enhance knee movement, particularly in fully straightening the knee. While specific data on the Graymont X ERIS is limited, braces in general are known to provide support during recovery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing primary ACL reconstruction without other repair procedures, except partial meniscectomy. Participants must have a confirmed full-thickness ACL tear and agree to surgery with patellar tendon autograft. They need to provide informed consent for the study.

Inclusion Criteria

I am having my first ACL surgery.

Written and informed consent for study participation

I have a complete ACL tear confirmed by MRI and will have surgery using a piece of my patellar tendon.

Exclusion Criteria

Inability to comply with the proposed follow-up clinic visits

I am unable to make my own medical decisions.

Pregnant or breast-feeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo ACL reconstruction surgery and are fitted with the assigned knee brace

1 day

1 visit (in-person)

Phase I: Protection, Range of Motion (ROM), and Proprioception

Focus on protecting the surgical graft, restoring lower extremity mobility, and proprioception

6 weeks

Standard of care office visits at 1-week, 2-week, and 6-weeks

Phase II: Strength and Endurance

Build single limb endurance and prepare for agility training

6 weeks

Standard of care office visits at 12-weeks

Phase III: Power and Agility

Gain type II, fast twitch muscle fibers and prepare for return to sport training

6 weeks

Phase IV: Return to Sport Training

Patients undergo sport-specific training with precautions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Standard of care office visits at 6-months

What Are the Treatments Tested in This Trial?

Interventions

• Knee Split Comparison After ACL Reconstruction
• Lake Effect Zero Degree Knee Splint
• Standard Hinge Knee Brace

Trial Overview The study compares two postoperative braces after ACL reconstruction: the Graymont X ERIS Knee Splint and a standard hinged knee brace. It measures how well each brace helps patients straighten their leg and how quickly they can do it compared to their other leg.

How Is the Trial Designed?

Group I: Graymont X ERIS Knee Splint Degree Splinting Group Experimental Treatment 1 Intervention

These patients will be randomized to receive the Graymont X ERIS Knee Splint. Patients will follow the same standardized postoperative rehabilitation protocol.

Group II: Standard Hinged Knee Brace Placebo Group 1 Intervention

These patients will be randomized to receive a standard hinged knee brace. Patients will follow the same standardized postoperative rehabilitation protocol.

Standard Hinge Knee Brace is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Standard Hinge Knee Brace for:

• Postoperative support and stabilization of the knee joint after ACL reconstruction
• Knee injuries
• Knee surgeries

Approved in European Union as Hinged Knee Brace for:

• Postoperative support and stabilization of the knee joint after ACL reconstruction
• Knee injuries
• Knee surgeries

Approved in Canada as Knee Immobilizer for:

• Postoperative support and stabilization of the knee joint after ACL reconstruction
• Knee injuries
• Knee surgeries

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

Prophylactic knee braces are ineffective at preventing injuries and may even increase the risk of knee injuries due to their current design.

Rehabilitative braces are beneficial for treating ligament injuries by controlling joint motion, but they offer limited support under high-load conditions, making their effectiveness in sports questionable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of bracing for the anterior cruciate ligament-deficient knee. Millet, CW., Drez, DJ.[2005]

In a study involving 10 subjects with ACL-deficient knees, two custom-made braces showed the best objective and subjective improvements in knee stability during functional tests.

Laterally hinged braces were found to be as effective as double-hinged models, suggesting they are a good option for nonoperative treatment of symptomatic ACL-deficient knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional testing of braces for anterior cruciate ligament-deficient knees. Marans, HJ., Jackson, RW., Piccinin, J., et al.[2016]

A uniaxial hinged functional brace significantly improves knee stability in ACL reconstructed patients, particularly at 30 degrees of knee flexion, but its effectiveness decreases at deeper flexion angles, showing only 4% improvement at 90 degrees.

Proper sizing, fitting, and hinge placement are crucial for maximizing the brace's effectiveness, and using adaptive fittings like flexible pads and polycentric joints could enhance overall performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthrometric evaluation of stabilizing effect of knee functional bracing at different flexion angles. Seyed Mohseni, S., Moss, F., Karimi, H., et al.[2021]

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]

A meta-analysis of literature on knee braces after anterior cruciate ligament (ACL) reconstruction found no clinical evidence supporting their effectiveness in improving postoperative outcomes, based on various studies.

The analysis indicated that while braces may provide limited stabilization under low shear stress, their systematic use in rehabilitation after ACL surgery is not recommended, as modern surgical techniques allow for effective recovery without them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To brace or not to brace? How effective are knee braces in rehabilitation? Martinek, V., Friederich, NF.[2019]

A meta-analysis of clinical and experimental studies found no evidence that knee braces improve postoperative outcomes after anterior cruciate ligament (ACL) reconstruction, suggesting their use in rehabilitation is not beneficial.

While braces may provide limited stabilization under low shear stress, they are not effective for ACL insufficient knee joints, and modern surgical techniques allow for rehabilitation without the need for external fixation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[To brace or not to brace? How effective are knee braces in rehabilitation?]. Martinek, V., Friederich, NF.[2022]

In a biomechanical study involving 18 fresh frozen cadaveric knees, preventive knee braces (McDavid Knee Guard and Omni Anderson Knee Stabler) did not provide significant protection against medial collateral ligament (MCL) injuries under valgus forces.

The study identified four potential adverse effects of using these braces, including MCL preload and brace slippage, suggesting that while braces are intended for injury prevention, they may introduce new risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biomechanics of lateral knee bracing. Part I: Response of the valgus restraints to loading. Paulos, LE., France, EP., Rosenberg, TD., et al.[2022]

The double-hinged, single-sided knee brace is designed to allow full movement (flexion and extension) of the knee while effectively preventing harmful valgus stress, which can lead to joint damage.

This innovative design aims to provide support and protection for the knee during activities, making it a useful intervention for individuals at risk of knee injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anderson Knee Stabler. Anderson, G., Zeman, SC., Rosenfeld, RT.[2016]

In a study of 969 athletes recovering from anterior cruciate ligament reconstruction, different types of knee braces (rigid, articulated, or no brace) did not show significant differences in clinical outcomes such as pain, range of motion, or complication rates during early rehabilitation.

Patients using a rigid brace experienced limited knee flexion in the early stages of recovery, suggesting that this type of brace may hinder mobility without providing additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No beneficial effect of bracing after anterior cruciate ligament reconstruction in a cohort of 969 athletes followed in rehabilitation. Bordes, P., Laboute, E., Bertolotti, A., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04360928

Knee Split Comparison After ACL Reconstruction | ... This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, ...

2. withpower.com withpower.com/trial/knee-braces-for-acl-injury-ab10a

Knee Braces for ACL Injury · Info for Participants This study will evaluate the efficacy of the Graymont X ERIS Knee Splint brace in the postoperative period of ACL reconstruction to improve range of motion, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10891282/

Effect of knee bracing on clinical outcomes following ... This study was conducted to assess the effectiveness of bracing in terms of knee function and stability following ACL reconstruction, regardless ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6508517/

The Effect of Functional Knee-Braces on Strain on ... Evidence suggests that a brace has a beneficial effect; it protects healing or damaged tissues and may possibly prevent reinjury. However, recent biomechanical ...

5. ftrdergisi.com ftrdergisi.com/uploads/pdf/pdf_4379.pdf

Prescription of knee braces after anterior cruciate ligament ... Conclusion: According to the results of this study, there was no significant difference between the rehabilitative brace and no brace groups in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000598

Functional Bracing After Anterior Cruciate Ligament ... Functional knee bracing (FKB) has been proposed as a strategy to reduce both initial injuries and reinjuries following ACL reconstruction (ACLR). The current ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6723618/

Evidence-based recommendations for the management of ... Anterior cruciate ligament (ACL) rupture occurs most commonly in young and active individuals and can have negative long-term physical and psychological impacts ...

8. bjsm.bmj.com bjsm.bmj.com/content/57/23/1490

Healing of acute anterior cruciate ligament rupture on MRI ... The objective of this study was to investigate MRI evidence of ACL healing, patient-reported outcomes and knee laxity in the first 80 individuals with acute ACL ...