Prospective Robotic-Guided Registry of Spine Surgery (PRoGRSS)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Spinal Disease
• Intervention / Treatment: Procedure: Robotic-guided spine surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Reston, Virginia, United States, 20191
      • National Spine Health Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.

Description

Inclusion Criteria:

• Any pediatric, adolescent or adult patient
• Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.

Exclusion Criteria:

• Pregnancy
• active infection
• malignancy
• primary abnormalities of bone
• primary muscle diseases (e.g., muscular dystrophy)
• neurologic diseases
• spinal cord abnormalities/lesions
• paraplegia.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic-guided surgery group; Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.	Procedure: Robotic-guided spine surgery; The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate clinical outcomes, as determined by all cause revisions	To determine the rate of revision surgery for all causes within 1 year	1 year after surgery
To evaluate clinical outcomes, by surgical complications	To determine the rate of surgical complications (wound infection/dehiscence, major neurological deficit, hemorrhage, dural tear)	1 year after surgery
To evaluate clinical outcomes, by patient reported outcome measures	To evaluate for changes in Patient Reported Outcomes Measurement Information System (PROMIS) scores over 1 year; (PROMIS scores are calculated at T-scores on a 0-100 point scale - for positively worded functions, such as physical function and global health, the higher the score the better the outcome; but for negatively worded functions, like pain interference, the higher the score the worse the outcome).	1 year after surgery
To evaluate clinical outcomes, by patient disability rating	To evaluate for changes in Oswestry Disability Index (ODI) scores over 1 year; disability scores range from 0-100, the higher the score the worse the outcome/disability.	1 year after surgery

Collaborators and Investigators

• Sponsor: The National Spine Health Foundation
• Collaborators: Medtronic
• Investigators: Principal Investigator: Christopher Good, MD, Virginia Spine Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Robotic-guided spine surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: ROB-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No