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

Rush

Status: Begins enrollment this month

Conditions: Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Treatments: Device: Arm 2-Breg T-Scope brace; Device: Arm 1-Kronos brace

Study type: Interventional

Funder types: Other

Identifiers

NCT07090616

25020201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm 1-Kronos brace

Experimental group

Description:

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

Treatment:

Device: Arm 1-Kronos brace

Arm 2-Breg T-Scope brace

Active Comparator group

Description:

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

Treatment:

Device: Arm 2-Breg T-Scope brace