Prospective Robotic Global Research Study (PROGRESS)

• Sponsor: Globus Medical Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04257279
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Disease	Procedure: ExcelsiusGPS™	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Robotic Global Research Study (PROGRESS)
• Actual Study Start Date: Dec 18, 2019
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale [Baseline]

   Pain rating scale

2. Numeric Rating Scale [2 weeks]

   Pain rating scale

3. Numeric Rating Scale [3 months]

   Pain rating scale

4. Numeric Rating Scale [6 months]

   Pain rating scale

5. Numeric Rating Scale [12 months]

   Pain rating scale

6. Numeric Rating Scale [24 months]

   Pain rating scale

7. Oswestry Disability Index [Baseline]

   Index derived from the Oswestry Low Back Pain Questionnaire

8. Oswestry Disability Index [2 weeks]

   Index derived from the Oswestry Low Back Pain Questionnaire

9. Oswestry Disability Index [3 months]

   Index derived from the Oswestry Low Back Pain Questionnaire

10. Oswestry Disability Index [6 months]

    Index derived from the Oswestry Low Back Pain Questionnaire

11. Oswestry Disability Index [12 months]

    Index derived from the Oswestry Low Back Pain Questionnaire

12. Oswestry Disability Index [24 months]

    Index derived from the Oswestry Low Back Pain Questionnaire

13. SF-12 [Baseline]

    12-Item short form health survey

14. SF-12 [2 weeks]

    12-Item short form health survey

15. SF-12 [3 months]

    12-Item short form health survey

16. SF-12 [6 months]

    12-Item short form health survey

17. SF-12 [12 months]

    12-Item short form health survey

18. SF-12 [24 months]

    12-Item short form health survey

19. Screw Placement Accuracy [2 weeks]

    Gertzbein Robbins Scale for screw accuracy

20. Complications [through study completion, 2 years]

    Adverse Event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southeastern Spine Institute	Mount Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

• Globus Medical Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Globus Medical Inc
• ClinicalTrials.gov Identifier: NCT04257279
• Other Study ID Numbers: RGC18-002
• First Posted: Feb 6, 2020
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Globus Medical Inc: spine

Study Results

No Results Posted as of Oct 19, 2021