BAGUERA®C Study #16002

Cervical Arthroplasty using BAGUERA® C: A two-year, prospective, clinical follow-up data registry. Retrospective radiographic evaluation

Not FDA approved. Non-US study

Region: Europe

Status: Completed

 

Pilot study for registration in various countries

 

Primary Objectives:

- Motion at the treated level after two years of total disc replacement (TDR) using Baguera C prosthesis, evaluated by its range of motion (ROM)

between flexion and extension; motion occurs when ROM value is at least 2°;
- Disc height restoration after two years of total disc replacement (TDR)

using Baguera C prosthesis.

 

Secondary Objectives:

- Motion at the adjacent level after two years of total disc replacement (TDR) using Baguera C prosthesis, evaluated by its range of motion (ROM)

between flexion and extension; motion occurs when ROM value is at least 2°;
- Overall cervical alignment,  evaluated as overall lordosis by measuring C2-C7 ROM;
- Balance of the spine, evaluated by the angle of functional spine unit (FSU) at the treated level;
- Impact on adjacent levels, evaluated by the upper adjacent angle and the upper disc height.

 

Indication - condition:

Symptomatic cervical degenerative disc disease one or two levels from C3 to C7

 

Study type:

Observational, prospective data collection (registry), retrospective analysis, multicenter cohort study

 

Patients enrolled:

96

 

Primary outcomes:

• ROM FSU : Range of motion (ROM) of the Functional Spine Unit (FSU)
• HEIGHT: Disc Height

 

Secondary outcomes:

• UPPER ROM: Range of motion of the Upper Functional Spine Unit
• ROM C2-C6: Range of motion of C2-C6 levels
• ROM C2-C7: Range of motion of C2-C7 levels
• ANGLE FSU: Angle of the Functional Spine Unit
• UPPER ANGLE: Angle of the Upper Functional Spine Unit
• ANGLE C2-C6: Angle of C2-C6 levels
• ANGLE C2-C7: Angle of C2-C7 levels
• UPPER HEIGHT: Disc Height of the Upper Functional Spine Unit