Prospective Robotic-Guided Registry of Spine Surgery
PRoGRSS
1 other identifier
observational
1,000
1 country
1
Brief Summary
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2020
CompletedFirst Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 5, 2023
April 1, 2023
3.2 years
September 10, 2021
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To evaluate the success of robotic-guided spine surgery, from planning to execution.
To evaluate the success from planning to execution of robotic screw placement.
1 year after surgery
To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
To determine screw accuracy
1 year after surgery
To evaluate the success of robotic-guided spine surgery, by revision surgery rates.
To determine the rate of revision surgery due to symptomatic screw malposition within 1 year
1 year after surgery
To evaluate the success of robotic-guided spine surgery, by the radiation exposure.
To determine radiation exposure to the patient and surgeon.
1 year after surgery
Secondary Outcomes (4)
To evaluate clinical outcomes, as determined by all cause revisions
1 year after surgery
To evaluate clinical outcomes, by surgical complications
1 year after surgery
To evaluate clinical outcomes, by patient reported outcome measures
1 year after surgery
To evaluate clinical outcomes, by patient disability rating
1 year after surgery
Study Arms (1)
Robotic-guided surgery group
Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.
Interventions
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.
Eligibility Criteria
Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.
You may qualify if:
- Any pediatric, adolescent or adult patient
- Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
You may not qualify if:
- Pregnancy
- active infection
- malignancy
- primary abnormalities of bone
- primary muscle diseases (e.g., muscular dystrophy)
- neurologic diseases
- spinal cord abnormalities/lesions
- paraplegia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The National Spine Health Foundationlead
- Medtroniccollaborator
Study Sites (1)
National Spine Health Foundation
Reston, Virginia, 20191, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Good, MD
Virginia Spine Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2021
First Posted
January 6, 2022
Study Start
November 5, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
No plan to share data.