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

21 Participants Needed

Trial Summary

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 data supports the idea that Knee Braces for ACL Injury is an effective treatment?

The available research shows that knee braces can provide some stability for ACL-deficient knees, especially when customized braces are used. For example, a study found that two customized braces improved knee function and stability during activities that rely on the ACL. However, other studies suggest that knee braces do not significantly improve outcomes after ACL reconstruction surgery. In fact, some research indicates that braces may not be effective in preventing knee injuries or improving rehabilitation outcomes. Overall, while knee braces might help in certain non-surgical situations, their effectiveness after ACL surgery is questionable. ^{1 2 3 4 5}

What safety data exists for knee braces used in ACL injury treatment?

The safety data for knee braces in ACL injury treatment includes studies on their effectiveness and potential adverse effects. Functional braces have shown significant stabilizing effects in ACL-deficient knees and during various knee flexion angles. However, some studies indicate that braces can cause damage if applied incorrectly, and certain braces may not provide significant protection against ligament disruptions. Adverse effects such as MCL preload, center axis shift, premature joint line contact, and brace slippage have been noted in some cases. ^{1 2 6 7 8}

Is the Standard Hinge Knee Brace a promising treatment for ACL injury?

The Standard Hinge Knee Brace, also known as a Hinged Knee Brace, is not considered a promising treatment for ACL injuries. While it may offer some stability for low-stress activities, it does not significantly improve outcomes after ACL surgery or provide enough support during high-stress activities. Therefore, its effectiveness is limited. ^{1 3 5 8 9}

What is the purpose of this trial?

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, specifically the achievement of terminal extension and time-to-achievement compared to the standard hinged knee brace. This will be directly measured with goniometric angle and heel-height measurements relative to the contralateral side. Other metrics will include standard, validated patient reported outcomes and requirements for additional interventions to treat extension deficits including, but not limited to, additional therapy, intraarticular injections, oral corticosteroids, manipulation under anesthesia, or arthroscopic arthrolysis.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Functional testing of braces for anterior cruciate ligament-deficient knees. [2016]

2. Turkey pubmed.ncbi.nlm.nih.gov

Arthrometric evaluation of stabilizing effect of knee functional bracing at different flexion angles. [2021]

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

[To brace or not to brace? How effective are knee braces in rehabilitation?]. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

No beneficial effect of bracing after anterior cruciate ligament reconstruction in a cohort of 969 athletes followed in rehabilitation. [2018]

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

Principles of bracing for the anterior cruciate ligament-deficient knee. [2005]

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

The biomechanics of lateral knee bracing. Part I: Response of the valgus restraints to loading. [2022]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

The Anderson Knee Stabler. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

To brace or not to brace? How effective are knee braces in rehabilitation? [2019]