NCT04257279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

April 29, 2019

Last Update Submit

October 15, 2021

Conditions

Lumbar Disc Disease

Keywords

spine

Outcome Measures

Primary Outcomes (20)

  • 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

Study Arms (1)

Robotic

EXPERIMENTAL

Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS

Procedure: ExcelsiusGPS™

Interventions

ExcelsiusGPS™PROCEDURE

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.

Robotic

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeastern Spine Institute

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral disc disease

Central Study Contacts

Samantha Greeley, BS

CONTACT

6109301800sgreeley@globusmedical.com

Brandon Bucklen, PhD

CONTACT

6109301800bbucklen@globusmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

February 6, 2020

Study Start

December 18, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)