KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arm 1-Kronos brace, Arm 2-Breg T-Scope brace.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament (ACL) Reconstruction Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of the KRONOS Versus Breg T-Scope Post-operative Knee Braces Following Anterior Cruciate Ligament (ACL) Reconstruction
Overview
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.
Interventions
- Device 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 - Device 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 measures
- Rates of extension deficit [Time frame: 1 year post-operative]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT07090616 · 25020201