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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether wearing a special brace after ACL surgery aids recovery and reduces the risk of re-injury. The study compares outcomes between those using a brace post-surgery and those who do not. It focuses on individuals who play sports, have experienced a complete ACL tear, and plan to undergo a specific type of ACL surgery using part of their own quadriceps tendon.

As an unphased trial, it provides participants the chance to contribute to valuable research that could enhance recovery strategies for future patients.

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 prior data suggests that post-surgical functional bracing is safe for ACL reconstruction?

Research shows that many surgeons use braces after ACL surgery, with about 53% preferring models like the DonJoy Defiance Pro. This brace has been popular for over 20 years and is used by many professional athletes.

Studies have found that knee braces are generally safe, and most patients tolerate them well. However, some research has not found clear proof that these braces improve surgery outcomes, such as enhancing knee stability or speeding up recovery. While they are safe, experts do not fully agree on their effectiveness for recovery.

In summary, using braces like the DonJoy Defiance Pro after surgery is considered safe due to their long-standing use. However, their benefits for recovery remain under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about post-surgical functional bracing with the DonJoy Defiance Pro because it could offer better support and protection to the knee after ACL reconstruction surgery. Unlike the standard of care, which often involves rehabilitation without a brace, this treatment uses a specially designed brace to potentially enhance stability and reduce the risk of reinjury during recovery. This approach might help patients regain confidence and mobility faster, making it an appealing option for those looking to return to their normal activities sooner.

What evidence suggests that post-surgical functional bracing is effective for ACL reconstruction?

This trial will compare post-surgical functional bracing with no bracing after ACL (anterior cruciate ligament) surgery. Research has shown that knee braces can limit shinbone movement in controlled environments. However, their effect on recovery after ACL surgery remains unclear. A survey found that 53% of surgeons recommend braces post-surgery, yet a review of multiple studies found no strong evidence that braces improve recovery. In summary, while braces might enhance stability in some cases, no solid proof exists that they significantly aid recovery after ACL surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Brian Waterman, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40686529/

Functional Bracing After Anterior Cruciate Ligament ... (1)Functional knee braces have been shown to reduce anterior tibial translation in controlled conditions but show inconsistent effects on ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06942754

Bracing and Reconstruction of the Anterior Cruciate ... A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction.

3. withpower.com withpower.com/trial/bracing-for-acl-injury-5cfa4

Bracing for ACL Injury (BRACE Trial) A meta-analysis of clinical and experimental studies found no evidence that knee braces improve postoperative outcomes after anterior cruciate ligament (ACL) ...

4. ctv.veeva.com ctv.veeva.com/study/bracing-and-reconstruction-of-the-anterior-cruciate-ligament-for-efficacy-trial

Bracing and Reconstruction of the Anterior Cruciate Ligament ... A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274298/

Functional Bracing After Anterior Cruciate Ligament ... Functional knee braces have been shown to reduce anterior tibial translation in controlled conditions but show inconsistent effects on ...

6. ce.mayo.edu ce.mayo.edu/sites/default/files/DJ20-MKT00-10181-RevA-ACL-Family-Brochure-Final.pdf

ACL KNEE BRACING ... after anterior cruciate ligament reconstruction surgery: Two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med 2011; 39(3): ...

7. enovis.com enovis.com/products/donjoy/defiance-pro

Defiance Pro - DonJoy DonJoy's Defiance® has been the world's leading custom knee brace for over 20 years. Over 2 million Defiance braces have been prescribed to elite professional ...