A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF (NCT01640977) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
United States67 participantsStarted 2012-06
Plain-language summary
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
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
. Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
. 18+ years of age at the date of written informed consent;
. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
. Signed and dated informed consent form.
Exclusion criteria
. Mental or physical condition that would limit the ability to comply with study requirements;
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.
. Spine abnormality requiring treatment at more than two levels;
. Prior surgery at operative or adjacent level(s);
. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
. Participating in another clinical study that would confound study data.