Prospective Robotic Global Research Study (PROGRESS) (PROGRESS)

The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Procedure: ExcelsiusGPS™

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Greeley, BS; Phone Number: 2509 6109301800; Email: sgreeley@globusmedical.com
• Study Contact Backup: Name: Brandon Bucklen, PhD; Phone Number: 2517 6109301800; Email: bbucklen@globusmedical.com

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Recruiting
      • Southeastern Spine Institute
      • Contact: Karen Blakely, RN; Phone Number: 843-284-4738; Email: karen.blakely@southeasternspine.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age and a maximum age of 85 years
• Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
• Able to sign Informed Consent

Exclusion Criteria:

• Previous fusion or fusion attempt at index level(s)
• DEXA score of -2.5 or below (only if clinically indicated - optional)
• Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
• History of substance abuse (drugs or alcohol)
• Mentally incompetent or prisoner
• Worker's compensation
• Pregnant or intention to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic; Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS	Procedure: ExcelsiusGPS™; The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	Pain rating scale	Baseline
Numeric Rating Scale	Pain rating scale	2 weeks
Numeric Rating Scale	Pain rating scale	3 months
Numeric Rating Scale	Pain rating scale	6 months
Numeric Rating Scale	Pain rating scale	12 months
Numeric Rating Scale	Pain rating scale	24 months
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	Baseline
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	2 weeks
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	3 months
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	6 months
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	12 months
Oswestry Disability Index	Index derived from the Oswestry Low Back Pain Questionnaire	24 months
SF-12	12-Item short form health survey	Baseline
SF-12	12-Item short form health survey	2 weeks
SF-12	12-Item short form health survey	3 months
SF-12	12-Item short form health survey	6 months
SF-12	12-Item short form health survey	12 months
SF-12	12-Item short form health survey	24 months
Screw Placement Accuracy	Gertzbein Robbins Scale for screw accuracy	2 weeks
Complications	Adverse Event	through study completion, 2 years

Collaborators and Investigators

• Sponsor: Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: spine
• Other Study ID Numbers: RGC18-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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