NCT05181098

Prospective Robotic-Guided Registry of Spine Surgery

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The National Spine Health Foundation · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

Detailed description

What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries. It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature. The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Conditions

• Spinal Disease

Interventions

Type	Name	Description
PROCEDURE	Robotic-guided spine surgery	The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.

Timeline

• Start date: 2020-11-05
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-01-06
• Last updated: 2023-04-05

Locations

1 site across 1 country: United States