Prospective Robotic Global Research Study (PROGRESS)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04257279

Acronym

PROGRESS

Enrollment

200

Registered

2020-02-06

Start date

2019-12-18

Completion date

2021-12-31

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Disease

Keywords

spine

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.

Interventions

PROCEDUREExcelsiusGPS™

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactSamantha Greeley, BS

sgreeley@globusmedical.com6109301800

Backup ContactBrandon Bucklen, PhD

bbucklen@globusmedical.com6109301800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026