A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis
Otto Bock Healthcare Products GmbH
Summary
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DeviceC-Brace
The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Locations (76)
- Jonesboro P&O x Ottobock.careHarrison, Arkansas
- Jonesboro P&O x Ottobock.careRogers, Arkansas
- Bionics Orthotics & ProstheticsSan Diego, California
- ABI P&OSan Diego, California
- West Coast Brace & Limb - Palm HarborPalm Harbor, Florida
- Hanger - SarasotaSarasota, Florida