Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 … (NCT05610397) | Clinical Trial Compass
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Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels
200 participantsStarted 2023-04-24
Plain-language summary
This is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.
Who can participate
Age range
21 Years – 65 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:
* Diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery.
* 2 levels, between:
* C: C2-T1 (neck)
* M: L2-S1 (low back)
* Skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine.
Exclusion Criteria:
* Subject who had surgery with the STALIF devices at more than 2-levels.
* In the Investigator's opinion, the subject diagnosed with a disease or condition, which precludes the possibility of healing at the time of surgery
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.