Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Terminated

• Conditions: Degenerative Spine Disease; Spinal Deformity

• Registration Number: NCT02212899
• Lead Sponsor: Mazor Robotics

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2014-05-11
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Study Start: 2015-02-18
• Primary Completion: 2016-12-30
• Study Completion: 2016-12-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes as measured on plain radiographs	Within 10 years of surgery	sagittal and coronal alignment in reconstructive surgeries for spinal deformities
Surgical complications	Within 10 years of surgery	new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss
Reoperation rates	Within 10 years of surgery	Any revision surgery on the segment of interest
Radiation exposure	Day of surgery	Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room

Secondary Outcome Measures

Name	Time	Method
Clinical performance of instrumentation technique	Day of surgery	implant instrumentation time, total surgery time
Ratio of executed vs. planned screws	Day of surgery	Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause
Number of abandoned screws	Day of surgery	the number of screws not instrumented and the reason
Neuromonitoring events	Day of surgery
Length of convalescence	within 2 years of surgery	Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities
Improvement in health-related quality of life metrics	up to 10 years post-operative	back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices
Fusion rates/pseudoarthrosis	Within 1 year of surgery	The rate of fusion as determined within one year of surgical procedure.
Implant placement accuracy	Within one year post-surgery	Accuracy of implants as measured on a post-operative CT scan (when available)

Trial Locations

Locations (4)

Tabor Orthopedics; 🇺🇸 Memphis, Tennessee, United States

Lyerly Baptist/ Lyerly Neurosurgery; 🇺🇸 Jacksonville, Florida, United States

Spine Associates; 🇺🇸 Houston, Texas, United States

The Virginia Spine Institute; 🇺🇸 Reston, Virginia, United States