Spinal DiseasePRoGRSSNCT05181098
Prospective Robotic-Guided Registry of Spine Surgery
An observational study of Spinal Disease, run by The National Spine Health Foundation at 1 site in United States.
Trial summary
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Spinal Disease
- What is being tested?
- Robotic-guided spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.
Who may be able to join
- Any pediatric, adolescent or adult patient
- Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
Who cannot join
- Pregnancy
- active infection
- malignancy
- primary abnormalities of bone
- primary muscle diseases (e.g., muscular dystrophy)
- neurologic diseases
- spinal cord abnormalities/lesions
- paraplegia.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Spine Health Foundation
Reston, Virginia, 20191
About this study
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.
Read the detailed description
What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.
It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.
The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.
- Conditions
- Spinal Disease
- Being tested
- Robotic-guided spine surgery
- Keywords
- Robotic-guided spine surgery
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-guided spine surgeryProcedure or surgery
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-guided surgery group | Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80. Receives: Procedure: Robotic-guided spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the success of robotic-guided spine surgery, from planning to execution.
To evaluate the success from planning to execution of robotic screw placement.
Measured: 1 year after surgery
To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
To determine screw accuracy
Measured: 1 year after surgery
To evaluate the success of robotic-guided spine surgery, by revision surgery rates.
To determine the rate of revision surgery due to symptomatic screw malposition within 1 year
Measured: 1 year after surgery
To evaluate the success of robotic-guided spine surgery, by the radiation exposure.
To determine radiation exposure to the patient and surgeon.
Measured: 1 year after surgery
Secondary outcomes (4)
To evaluate clinical outcomes, as determined by all cause revisions
To determine the rate of revision surgery for all causes within 1 year
Measured: 1 year after surgery
To evaluate clinical outcomes, by surgical complications
To determine the rate of surgical complications (wound infection/dehiscence, major neurological deficit, hemorrhage, dural tear)
Measured: 1 year after surgery
To evaluate clinical outcomes, by patient reported outcome measures
To evaluate for changes in Patient Reported Outcomes Measurement Information System (PROMIS) scores over 1 year; (PROMIS scores are calculated at T-scores on a 0-100 point scale - for positively worded functions, such as physical function and global health, the higher the score the better the outcome; but for negatively worded functions, like pain interference, the higher the score the worse the outcome).
Measured: 1 year after surgery
To evaluate clinical outcomes, by patient disability rating
To evaluate for changes in Oswestry Disability Index (ODI) scores over 1 year; disability scores range from 0-100, the higher the score the worse the outcome/disability.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start5 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The National Spine Health Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Christopher Good, MD, Principal investigator, Virginia Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181098
- Sponsor's protocol ID
- ROB-002
- Acronym
- PRoGRSS
- Status last verified
- Apr 2023
- First submitted
- 10 Sep 2021
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Robotic-Guided Registry of Spine Surgery
- ClinicalTrials.gov ID
- NCT05181098
- Acronym / sponsor ID
- PRoGRSS / ROB-002
- Conditions
- Spinal Disease
- Keywords
- Robotic-guided spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The National Spine Health FoundationUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jan 2022 (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.
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.
Detailed description
What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.
It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.
The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-guided surgery group | – | Procedure: Robotic-guided spine surgeryAny pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.
Key inclusion criteria (2 listed)
- Any pediatric, adolescent or adult patient
- Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
Key exclusion criteria (8 listed)
- Pregnancy
- active infection
- malignancy
- primary abnormalities of bone
- primary muscle diseases (e.g., muscular dystrophy)
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 |
|---|---|---|
| Robotic-guided spine surgeryThe Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery. | Procedure or surgery | Robotic-guided surgery group |
Primary outcome
To evaluate the success of robotic-guided spine surgery, from planning to execution.
Time frame: 1 year after surgery
To evaluate the success from planning to execution of robotic screw placement.
To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
Time frame: 1 year after surgery
To determine screw accuracy
To evaluate the success of robotic-guided spine surgery, by revision surgery rates.
Time frame: 1 year after surgery
To determine the rate of revision surgery due to symptomatic screw malposition within 1 year
To evaluate the success of robotic-guided spine surgery, by the radiation exposure.
Time frame: 1 year after surgery
To determine radiation exposure to the patient and surgeon.
4 secondary outcomes
To evaluate clinical outcomes, as determined by all cause revisions
Time frame: 1 year after surgery
To evaluate clinical outcomes, by surgical complications
Time frame: 1 year after surgery
To evaluate clinical outcomes, by patient reported outcome measures
Time frame: 1 year after surgery
To evaluate clinical outcomes, by patient disability rating
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No. No plan to share data.
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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.
Christopher Good, MD principal investigator
Virginia Spine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by The National Spine Health Foundation 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 2 inclusion and 8 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 5 Apr 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the success of robotic-guided spine surgery, from planning to execution. (time frame: 1 year after surgery). The study lists 4 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 5 Apr 2023.