Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Mazor Robotics

Status: Terminated

Conditions: Degenerative Spine Disease; Spinal Deformity

Study type: Observational

Funder types: Industry

Identifiers

NCT02212899

CLN111

Details and patient eligibility

About

To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

Full description

The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches.

The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

Enrollment: 93 patients

Sex: All

Ages: 6 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system.

Patient capable of complying with study requirements. Signed informed consent by patient.

Exclusion criteria

Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study.

Patient cannot follow study protocol, for any reason. Patient cannot or will not sign informed consent.