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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Yanke, MD PhD | Contact | (312) 432-2818 | cartilage.restoration@rushortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Chahla, MD PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
There is not a plan at this time to make IPD available
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2025 | Aug 14, 2025 |
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Randomized control trial 1:1 assignment (20 KRONOS Brace: 20 standard of care Breg T-Scope Brace)
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| 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. |
|
| Prot_000.pdf |