Lumbar Disc DiseasePROGRESSNCT04257279
Prospective Robotic Global Research Study (PROGRESS)
A study testing ExcelsiusGPS™ in people with Lumbar Disc Disease, run by Globus Medical Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- ExcelsiusGPS™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464
Karen Blakely, RN, 843-284-4738, karen.blakely@southeasternspine.com
About this study
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
- Being tested
- ExcelsiusGPS™
- Keywords
- spine
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExcelsiusGPS™Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS Receives: Procedure: ExcelsiusGPS™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Pain rating scale
Measured: Baseline
Numeric Rating Scale
Pain rating scale
Measured: 2 weeks
Numeric Rating Scale
Pain rating scale
Measured: 3 months
Numeric Rating Scale
Pain rating scale
Measured: 6 months
Numeric Rating Scale
Pain rating scale
Measured: 12 months
Numeric Rating Scale
Pain rating scale
Measured: 24 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: Baseline
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: 2 weeks
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: 3 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: 6 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: 12 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Measured: 24 months
SF-12
12-Item short form health survey
Measured: Baseline
SF-12
12-Item short form health survey
Measured: 2 weeks
SF-12
12-Item short form health survey
Measured: 3 months
SF-12
12-Item short form health survey
Measured: 6 months
SF-12
12-Item short form health survey
Measured: 12 months
SF-12
12-Item short form health survey
Measured: 24 months
Screw Placement Accuracy
Gertzbein Robbins Scale for screw accuracy
Measured: 2 weeks
Complications
Adverse Event
Measured: through study completion, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start18 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Globus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257279
- Sponsor's protocol ID
- RGC18-002
- Acronym
- PROGRESS
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Robotic Global Research Study (PROGRESS)
- ClinicalTrials.gov ID
- NCT04257279
- Acronym / sponsor ID
- PROGRESS / RGC18-002
- Conditions
- Lumbar Disc Disease
- Keywords
- spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Globus Medical IncIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Procedure: ExcelsiusGPS™Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Robotic |
Primary outcome
Numeric Rating Scale
Time frame: Baseline
Pain rating scale
Numeric Rating Scale
Time frame: 2 weeks
Pain rating scale
Numeric Rating Scale
Time frame: 3 months
Pain rating scale
Numeric Rating Scale
Time frame: 6 months
Pain rating scale
Numeric Rating Scale
Time frame: 12 months
Pain rating scale
Numeric Rating Scale
Time frame: 24 months
Pain rating scale
Oswestry Disability Index
Time frame: Baseline
Index derived from the Oswestry Low Back Pain Questionnaire
Oswestry Disability Index
Time frame: 2 weeks
Index derived from the Oswestry Low Back Pain Questionnaire
Oswestry Disability Index
Time frame: 3 months
Index derived from the Oswestry Low Back Pain Questionnaire
Oswestry Disability Index
Time frame: 6 months
Index derived from the Oswestry Low Back Pain Questionnaire
Oswestry Disability Index
Time frame: 12 months
Index derived from the Oswestry Low Back Pain Questionnaire
Oswestry Disability Index
Time frame: 24 months
Index derived from the Oswestry Low Back Pain Questionnaire
SF-12
Time frame: Baseline
12-Item short form health survey
SF-12
Time frame: 2 weeks
12-Item short form health survey
SF-12
Time frame: 3 months
12-Item short form health survey
SF-12
Time frame: 6 months
12-Item short form health survey
SF-12
Time frame: 12 months
12-Item short form health survey
SF-12
Time frame: 24 months
12-Item short form health survey
Screw Placement Accuracy
Time frame: 2 weeks
Gertzbein Robbins Scale for screw accuracy
Complications
Time frame: through study completion, 2 years
Adverse Event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExcelsiusGPS™ in people with Lumbar Disc Disease, run by Globus Medical Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Greeley, BS (6109301800 ext. 2509, sgreeley@globusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.