Prospective Robotic Global Research Study (PROGRESS)

Globus Medical

Status: Unknown

Conditions: Lumbar Disc Disease

Treatments: Procedure: ExcelsiusGPS™

Study type: Interventional

Funder types: Industry

Identifiers

NCT04257279

RGC18-002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Robotic

Experimental group

Description:

Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS

Treatment:

Procedure: ExcelsiusGPS™