KRONOS vs Breg T-Scope Braces for ACL Surgery

Overseen By Adam Yanke, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Revision ACL, Multi-ligamentous injury, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different knee braces to determine which one aids recovery better after ACL (anterior cruciate ligament) surgery. One group will use the new KRONOS brace, while the other will use the standard Breg T-Scope brace. The researchers aim to discover if the KRONOS brace can reduce pain and accelerate recovery compared to the usual post-surgery brace. Individuals with a full ACL tear undergoing their first ACL surgery, without other major knee issues, may be suitable for this trial. As an unphased trial, this study allows participants to contribute to valuable research that could enhance recovery options for future patients.

Will I have to stop taking my current medications?

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 these knee braces are safe for ACL surgery?

Research has shown that knee braces, such as the KRONOS, are generally safe after ACL surgery. While specific safety data for the KRONOS brace is unavailable, knee braces are widely used and rarely cause serious side effects. Designed to support the knee and aid healing, most patients tolerate them well. Reports of major problems with knee braces are absent, indicating their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KRONOS knee brace because it offers a tailored fit from the start, with patients being measured and fitted at their initial clinic visit. This personalized approach could potentially improve comfort and support during recovery from ACL surgery. Unlike the standard Breg T-Scope brace, which is locked in full extension post-surgery, the KRONOS may offer more flexibility and adaptability to individual patient needs, enhancing overall rehabilitation outcomes.

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

Research shows that knee braces can improve knee function and comfort after ACL surgery. In this trial, participants will join one of two groups: one group will receive the KRONOS brace, designed to reduce pain and speed recovery, while the other group will receive the standard Breg T-Scope brace. Some studies suggest that wearing a brace after ACL surgery can lead to better recovery. However, other research indicates that the difference between wearing a brace and not wearing one might not be significant. The KRONOS brace aims to support and comfort during healing, enhancing recovery. ^{1 2 4 5 6}

Who Is on the Research Team?

Jorge Chahla, MD PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone ACL reconstruction surgery. Specific eligibility criteria are not provided, but typically participants should be in good health aside from their knee condition and willing to follow the study's procedures.

Inclusion Criteria

English-speaking

I have never had knee surgery on the knee that will be operated on.

I am over 18 years old.

Exclusion Criteria

I have injuries to multiple knee ligaments.

Inability to comply with the proposed follow-up clinic visits

Worker's compensation subjects

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fitted with either the KRONOS or Breg T-Scope knee brace post-operatively

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for knee extension deficit and recovery progress

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Breg T-Scope
• KRONOS

Trial Overview The study is testing the effectiveness of two different postoperative knee braces: the KRONOS brace versus the standard Breg T-Scope hinged brace. It aims to determine which brace better reduces pain and aids recovery after ACL surgery.

How Is the Trial Designed?

Group I: Arm 1-Kronos brace Experimental Treatment 1 Intervention

Subjects randomized to the treatment group will be measured and fitted with the KRONOS knee brace at their initial clinic visit after study enrollment.

Group II: Arm 2-Breg T-Scope brace Active Control 1 Intervention

Subjects randomized to the standard postoperative Breg T-Scope hinged knee brace in the operating room that will be locked in full extension.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT07090616/Prot_000.pdf

KRONOS Versus Breg T-Scope Post-operative Knee ... postoperative knee brace compared with the standard Breg T-scope hinged brace following anterior cruciate ligament (ACL) reconstruction surgery. Background ...

2. ctv.veeva.com ctv.veeva.com/study/kronos-versus-breg-t-scope-post-operative-knee-braces-following-anterior-cruciate-ligament-acl-rec

KRONOS Versus Breg T-Scope Post-operative Knee Braces ... The purpose of this study is to evaluate how well the KRONOS postoperative knee brace reduces pain and enhances recovery compared with the ...

3. withpower.com withpower.com/trial/phase-anterior-cruciate-ligament-acl-reconstruction-surgery-8-2025-aee43

KRONOS vs Breg T-Scope Braces for ACL Surgery The purpose of this study is to evaluate how well the KRONOS postoperative knee brace reduces pain and enhances recovery compared with the standard Breg ...

4. 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 ...

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. meddatax.com meddatax.com/clinical-trials/NCT07090616

KRONOS Versus Breg T-Scope Post-operative Knee Braces ... The purpose of this study is to evaluate how well the KRONOS postoperative knee brace reduces pain and enhances recovery compared with the ...