Study of Nucel for One and Two Level Lumbar Interbody Fusion

Status unconfirmed · Not applicable

Conditions studied: Degenerative Disc Disease, Spondylolisthesis, Spondylosis

In brief

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.

Key facts

Study ID

NCT02808234

Run by

Organogenesis

People needed

200

Starts

2015-12-01

Expected to finish

2022-12-01

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Morbid obesity (BMI > 40).
• Currently a prisoner.
• Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
• Pregnancy at the time of enrollment or planned pregnancy, which would interfere with follow-up imaging.

Where it is running

• Florida Orthopaedic Insitute — Tampa, Florida, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Carolina Neurosurgery & Spine — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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