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NCT Number: NCT07090616

KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction

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 T-scope hinged brace following anterior cruciate ligament (ACL) reconstruction knee surgery.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Adam Yanke, MD PhD

SUB_INVESTIGATOR

Jonathan Gustafson, PhD

CONTACT

[email protected]

312-432-2818

Jonathan Gustafson, PhD

SUB_INVESTIGATOR

Jorge Chahla, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

The KRONOS postoperative unloader brace features a new bracing technology that combines the capability of hyperextension immobilization with additional benefits of offloading up to 60 lbs off the knee joint. The adjustable tensioning system in the KRONOS brace offers promising potential to significantly alleviate patient discomfort and pain, facilitate quicker return to a higher level of activity, and ultimately contribute to improved surgical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects > 18 years of age
  • English-speaking
  • Scheduled to undergo primary anterior cruciate ligament reconstruction surgery
  • No history of prior knee surgery on the operative knee
  • No concomitant ligamentous repair or reconstruction procedures (i.e. ligamentous pathology aside from anterior cruciate ligament).
  • Subjects undergoing concurrent partial meniscectomy or meniscus repair that would not alter postoperative weight-bearing status or rehabilitation protocol would be eligible for inclusion.
  • Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear

Exclusion criteria

  • Age < 18 years of age
  • Non-English speaking
  • Revision ACL reconstruction
  • Multi-ligamentous injury, including concomitant posterior cruciate ligament, medial collateral ligament and fibular collateral ligament injuries
  • Concomitant meniscal or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
  • Inability to comply with the proposed follow-up clinic visits
  • Subjects lacking decisional capacity
  • Worker's compensation subjects
  • Requiring a custom-sized brace

Treatment and study plan

Arm 1-Kronos brace

Device

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

Arm 2-Breg T-Scope brace

Device

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

Primary outcomes

  1. Rates of extension deficit

    Time frame: 1 year post-operative

    Rates of extension deficit (as measured by the fraction of patients with reduced extension compared to the contralateral determined by heel height and goniometric measurements of knee extension (cm/ degrees)

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Yanke, MD PhD

CONTACT

[email protected]

(312) 432-2818

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

A Randomized Controlled Trial of the KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 29, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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