Bracing for ACL Injury

(BRACE Trial)

Overseen By Katherine Leonard

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Prednisolone, Cytostatics

Disqualifiers: Multiligamentous injuries, Osteoarthritis, Dislocations, Malalignment, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 months

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with prolonged use of prednisolone or cytostatics (medications that suppress the immune system).

What data supports the effectiveness of the treatment Post-surgical Functional Bracing for ACL Injury?

Research shows that functional knee braces are often used to help stabilize the knee and support healing after an ACL injury. They may improve joint stability and help restore normal movement, although the results on their effectiveness are mixed. ^{1 2 3 4 5}

Is functional bracing for ACL injuries safe for humans?

The research does not specifically address safety concerns, but functional knee braces are commonly used after ACL injuries or surgeries, suggesting they are generally considered safe for human use. ^{1 6 7 8 9}

How does bracing differ from other treatments for ACL injuries?

Bracing for ACL injuries is unique because it aims to support the healing ligament and improve joint stability without surgery. Unlike surgical treatments, bracing is non-invasive and can be used to prevent reinjury, although its effectiveness is still debated and not consistently supported by scientific evidence. ^{1 4 6 8 10}

What is the purpose of this trial?

Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.

Research Team

Brian Waterman, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for individuals who have had surgery to repair an Anterior Cruciate Ligament (ACL) injury. The study aims to include those interested in testing the effectiveness of post-surgical functional bracing compared to not using a brace after ACL reconstruction.

Inclusion Criteria

I have a completely torn ACL in one knee.

I am an athlete wanting to return to sports.

I am having ACL surgery using a piece of my thigh muscle.

Exclusion Criteria

Pregnancy during injury or surgery

I have fractures in my leg bones.

I need surgery for injuries to two knee ligaments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo quadriceps autograft ACL reconstruction with or without functional bracing

6 months

Baseline and Months 3, 6

Follow-up

Participants are monitored for psychological readiness, clinical stability, and return to sport outcomes

18 months

Months 12 and 24

Treatment Details

Interventions

• Post-surgical Functional Bracing

Trial Overview The trial is examining if wearing a functional brace following ACL reconstruction surgery results in lower failure rates, better knee stability, and improved patient outcomes versus no bracing. It's exploring this question among people at high risk of complications.

Participant Groups

Group I: With postoperative brace (DonJoy Defiance Pro) Experimental Treatment 1 Intervention

Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace

Group II: Without post-surgical functional bracing Active Control 1 Intervention

Quadriceps Autograft ACL Reconstruction without the use of post-surgical functional bracing

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Functional bracing of ACL injuries: current state and future directions. [2022]

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

The effect of knee braces on tibial rotation in anterior cruciate ligament-deficient knees during high-demand athletic activities. [2022]

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

The effects of a functional knee brace during early treatment of patients with a nonoperated acute anterior cruciate ligament tear: a prospective randomized study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The effect of functional bracing on the arthrokinematics of anterior cruciate ligament injured knees during lunge exercise. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Influence of functional bracing on the kinetics of anterior cruciate ligament-injured knees during level walking. [2016]

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

The Role of Bracing in ACL Injuries: The Current Evidentiary State of Play. [2022]

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

The influence of functional knee bracing on the anterior cruciate ligament strain biomechanics in weightbearing and nonweightbearing knees. [2022]

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

Knee Bracing After Anterior Cruciate Ligament Reconstruction. [2022]

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

Risk of Secondary ACL Injury in Adolescents Prescribed Functional Bracing After ACL Reconstruction. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

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