Study of Nucel for One and Two Level Lumbar Interbody Fusion (NCT02808234) | Clinical Trial Compass
UnknownNot Applicable
Study of Nucel for One and Two Level Lumbar Interbody Fusion
United States200 participantsStarted 2015-12
Plain-language summary
The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.
Who can participate
Age range
18 Years – 75 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
. Be between 18 and 75 years of age
. Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
. In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
. Be likely to return for regular follow-ups until the end of the study period.
. Be willing and able to provide Informed Consent for study participation.
Exclusion criteria
. Previous lumbar spine fusion surgery at operative level.
. Back pain due to acute trauma.
. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
. No chronic steroid or chronic prescription NSAID use within three (3) months prior to 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.
What they're measuring
1
Fusion rate using non-contrast CT of the lumbar spine