Recruiting

Observational Study

Sponsor:

Globus Medical Inc

Code:

NCT04257279

Conditions

Lumbar Disc Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ExcelsiusGPS™

Study Details

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.

Conditions

Lumbar Disc Disease

Study ID

NCT04257279

Start date

Dec 18, 2019

Status verified date

Oct, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic

Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS

Interventions

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.

Primary outcome measure

  • Numeric Rating Scale [ Time Frame: Baseline ]
  • Numeric Rating Scale [ Time Frame: 2 weeks ]
  • Numeric Rating Scale [ Time Frame: 3 months ]
  • Numeric Rating Scale [ Time Frame: 6 months ]
  • Numeric Rating Scale [ Time Frame: 12 months ]
  • Numeric Rating Scale [ Time Frame: 24 months ]
  • Oswestry Disability Index [ Time Frame: Baseline ]
  • Oswestry Disability Index [ Time Frame: 2 weeks ]
  • Oswestry Disability Index [ Time Frame: 3 months ]
  • Oswestry Disability Index [ Time Frame: 6 months ]
  • Oswestry Disability Index [ Time Frame: 12 months ]
  • Oswestry Disability Index [ Time Frame: 24 months ]
  • SF-12 [ Time Frame: Baseline ]
  • SF-12 [ Time Frame: 2 weeks ]
  • SF-12 [ Time Frame: 3 months ]
  • SF-12 [ Time Frame: 6 months ]
  • SF-12 [ Time Frame: 12 months ]
  • SF-12 [ Time Frame: 24 months ]
  • Screw Placement Accuracy [ Time Frame: 2 weeks ]
  • Complications [ Time Frame: through study completion, 2 years ]

Central Contacts and Locations

Central contacts

Samantha Greeley, BS

6109301800sgreeley@globusmedical.com

Brandon Bucklen, PhD

6109301800bbucklen@globusmedical.com

Locations

Southeastern Spine Institute

Recruiting

Mount Pleasant, South Carolina, United States, 29464

Contacts

Karen Blakely, RN

843-284-4738karen.blakely@southeasternspine.com

More Information

Sponsor

Globus Medical Inc

Last update posted

Oct 19, 2021

Last verified

Oct, 2021

Keywords

  • spine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Globus Medical Inc on 2021-10-19.