Overview
To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.
Description
The purpose of the C-Brace Prospective Registry is to gather prospective baseline and follow-up data to characterize the safety and effectiveness of the C Brace. Patients casted for C-Brace fitting and willing to provide informed consent at participating clinics will be enrolled in the registry. All patients will be followed in accordance with the standard of care for a C-Brace, which will include, at a minimum, baseline evaluation, fitting, patient training/therapy sessions, follow-up at 6 months, 12 months, 24 months and 36 months after the definitive fitting of the C-Brace.
Eligibility
Inclusion Criteria:
- Patient has been evaluated and successfully tested with the Trial Tool, and has been casted for a C-Brace.
- Patient is able to communicate, provide feedback, understand and follow instructions during the course of the registry.
- Patient is willing to provide informed consent.
Exclusion Criteria:
- Patient is geographically inaccessible to comply and participate in the registry.
- Patient has not been casted for a C-Brace fitting.