Prospective Robotic Global Research Study (PROGRESS)

Lumbar Disc Disease Clinical Trial

— PROGRESS  

Official title:

Prospective Robotic Global Research Study (PROGRESS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257279
• Other study ID #: RGC18-002
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2021
• Source: Globus Medical Inc
• Contact: Samantha Greeley, BS
• Phone: 6109301800
• Email: sgreeley[@]globusmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Southeastern Spine Institute	Mount Pleasant	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

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