Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prev… (NCT04888104) | Clinical Trial Compass
RecruitingNot Applicable
Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
United States225 participantsStarted 2021-07-09
Plain-language summary
Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>18 years of age at the time of treatment
. EOS full body or standing 36" AP \& Lateral images of entire spine
. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels
. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system
. Upper instrumented vertebra (UIV) terminating at a newly instrumented level
. Surgery scheduled to take place in the next 6 months
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Scoliosis Research Society (SRS) 22r
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
2
Oswestry
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
3
Veterans RAND 12 Item Health Survey (VR-12)
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
4
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
5
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
6
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Timeframe: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
7
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function