Prospective Robotic Global Research Study (PROGRESS)

Not Applicable

• Conditions: Lumbar Disc Disease
• Interventions: Procedure: ExcelsiusGPS™

• Registration Number: NCT04257279
• Lead Sponsor: Globus Medical Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-29
• Study Start: 2019-12-18
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-19
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic	ExcelsiusGPS™	Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS

Primary Outcome Measures

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

Trial Locations

Locations (1)

Southeastern Spine Institute; 🇺🇸 Mount Pleasant, South Carolina, United States