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

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament (ACL) Reconstruction Surgery

• Registration Number: NCT07090616
• Lead Sponsor: Rush University Medical Center

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Study First Posted: 2025-07-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-30
• Primary Completion: 2027-09
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rates of extension deficit	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)

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States