Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Conditions
Keywords
Braces, Anterior cruciate ligament (ACL) reconstruction surgery
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.
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
DEVICEArm 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
DEVICEArm 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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized control trial 1:1 assignment (20 KRONOS Brace: 20 standard of care Breg T-Scope Brace)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of extension deficit | 1 year post-operative | 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) |
Countries
United States
Contacts
CONTACTAdam Yanke, MD PhD
PRINCIPAL_INVESTIGATORJorge Chahla, MD PhD
Rush University Medical Center
Outcome results
None listed