Prospective Robotic Global Research Study (PROGRESS)

Study Overview
=================
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.

Official Title
-----------------
Prospective Robotic Global Research Study (PROGRESS)

Conditions
-----------------
Lumbar Disc Disease

Intervention / Treatment
-----------------
* Procedure: ExcelsiusGPS™


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic<br>Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS | Procedure: ExcelsiusGPS™<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spine