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RecruitingNot ApplicableNCT07090616

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

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

Sponsor

Rush University Medical Center

Enrollment

40 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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
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Interventions

DEVICEArm 1-Kronos brace

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

DEVICEArm 2-Breg T-Scope brace

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.

Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT07090616