KRONOS vs Breg T‑Scope knee braces after ACL reconstruction
Official title: A Randomized Controlled Trial of the KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction
Run by Rush University Medical Center · NCT07090616 · Data updated 2026-11-12
This study tests whether the KRONOS postoperative knee brace reduces pain and helps adults recover faster than the standard Breg T‑Scope after ACL reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | February 11, 2025 |
| Main results expected | September 2027 |
| Study ends | January 2028 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07090616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults (over 18) scheduled for primary ACL reconstruction with no prior surgery on the operative knee and no multi-ligament injuries, although minor meniscal procedures that do not alter weight-bearing or rehab are allowed.
✕Probably not a fit
Patients having revision ACL surgery, multi-ligament injuries, concomitant meniscal or cartilage injuries that change weight-bearing or rehab, non-English speakers, and those under 18 are unlikely to qualify or benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial compares two postoperative knee braces: the KRONOS unloader brace, which combines hyperextension immobilization with an adjustable tensioning system that can offload up to 60 pounds, and the standard Breg T‑Scope hinged brace. Adults undergoing primary ACL reconstruction will be assigned to wear one of the braces during the standard postoperative rehabilitation and will be followed for pain, functional recovery, and return-to-activity outcomes. Data will include patient-reported pain scores, clinical assessments of knee function, and timing of activity milestones. The study keeps usual rehabilitation protocols unchanged to isolate the effects of the brace designs.
Why it matters
Potential benefit: If successful, the KRONOS brace could reduce postoperative pain and speed return to activity, improving overall recovery after ACL reconstruction.
How similar studies have gone: Hinged and unloader braces have been used in knee care with mixed results, but the KRONOS combination of hyperextension immobilization and high offloading is a novel design with limited clinical evidence to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Rush University Medical Center
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Jorge Chahla, MD PhD — Rush University Medical Center
- Study coordinator: Adam Yanke, MD PhD
- Email: cartilage.restoration@rushortho.com
- Phone: (312) 432-2818
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.