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

NCT07090616 | Recruiting FDA Device

• 1 other identifier: 25020201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Keywords

Braces; Anterior cruciate ligament (ACL) reconstruction surgery

Outcome Measures

Primary Outcomes (1)

• Rates of extension deficit

  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)

  1 year post-operative

Study Arms (2)

Arm 1-Kronos brace

EXPERIMENTAL

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

Device: Arm 1-Kronos brace

Arm 2-Breg T-Scope brace

ACTIVE COMPARATOR

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

Device: Arm 2-Breg T-Scope brace

Interventions

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 1-Kronos brace

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.

Arm 2-Breg T-Scope brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Study Officials

• Jorge Chahla, MD PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Yanke, MD PhD

CONTACT

(312) 432-2818; cartilage.restoration@rushortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial 1:1 assignment (20 KRONOS Brace: 20 standard of care Breg T-Scope Brace)

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)