Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®) (NCT00948532) | Clinical Trial Compass
CompletedNot Applicable
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
United States104 participantsStarted 2009-03
Plain-language summary
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
Who can participate
Age range
18 Years – 80 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
. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
. 18-80 years of age at the date of written informed consent
. Able to undergo surgery based on physical exam, medical history and surgeon judgment
. Expected to survive at least 2 years beyond surgery
. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
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
The proportion of subjects with radiographically apparent fusion.
. Patient has a mental or physical condition that would limit the ability to comply with study requirements
. Lumbar spine abnormality requiring treatment at more than two levels
. Systemic or local infection; active or latent
. Previous failed fusion at the operative level
. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
. Pregnant, or plans to become pregnant during the study