NCT04640584

C-Brace Prospective Registry

A Prospective Registry of Patients Fitted With a Microprocessor-controlled Knee Ankle Foot Orthosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Otto Bock Healthcare Products GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To gather prospective safety and effectiveness data for the C-Brace System following the standard of care.

Detailed 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.

Conditions

• Pareses
• Lower Extremity

Interventions

Type	Name	Description
DEVICE	C-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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2020-11-23
• Last updated: 2025-04-30

Locations

76 sites across 4 countries: United States, Australia, Germany, Japan