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 range18 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
âś“. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
âś“. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
âś“. 18-80 years of age at the date of written informed consent
âś“. Able to undergo surgery based on physical exam, medical history and surgeon judgment
âś“. Expected to survive at least 2 years beyond surgery
âś“. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
âś“. Signed and dated Informed Consent Form
Exclusion criteria
âś•. Patient has a mental or physical condition that would limit the ability to comply with study requirements
What they're measuring
1
The proportion of subjects with radiographically apparent fusion.
. Lumbar spine abnormality requiring treatment at more than two levels
âś•. Systemic or local infection; active or latent
âś•. Previous failed fusion at the operative level
âś•. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
âś•. 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)
âś•. Pregnant, or plans to become pregnant during the study