Recruiting

KRONOS & Breg

Sponsor:

Rush University Medical Center

Code:

NCT07090616

Conditions

Anterior Cruciate Ligament (ACL) Reconstruction Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arm 1-Kronos brace

Arm 2-Breg T-Scope brace

Study Details

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

Study ID

NCT07090616

Start date

Feb 11, 2025

Status verified date

Feb, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm 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.

active comparator: Arm 2-Breg T-Scope brace

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

Interventions

Arm 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

Arm 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.

Primary outcome measure

  • Rates of extension deficit [ Time Frame: 1 year post-operative ]

Central Contacts and Locations

Central contacts

Adam Yanke, MD PhD

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

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jonathan Gustafson, PhD

312-432-2818Jonathan.Gustafson@rushortho.com

Principal Investigator:

Jorge Chahla, MD PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Braces
  • Anterior cruciate ligament (ACL) reconstruction surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-02-12.