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 range18 Years – 75 Years
SexALL
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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.
✕. Any active malignancy, infectious process, or documented chronic autoimmune disease.
✕. Any other concurrent medical disease or treatment that might impair normal healing process.
✕. Recent history (within past 6 months) of any chemical or alcohol dependence.
What they're measuring
1
Fusion rate using non-contrast CT of the lumbar spine