Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)

Completed

Conditions studied: Degenerative Disc Disease in Cervical Spine

In brief

This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. 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).

Key facts

Study ID

NCT00942045

Run by

NuVasive

People needed

182

Starts

2009-02-01

Expected to finish

2012-10-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
• Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
• Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
• 18-70 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
• Signed and dated Informed Consent Form

You may not qualify if…

• Patient has a mental or physical condition that would limit the ability to comply with study requirements
• Cervical 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
• Subject is a prisoner
• Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
• A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents that decrease the probability of survival to the two-year endpoint of the study
• Participating in another clinical study at any time during the study participation that would confound study data

Where it is running

• Shiley Center for Orthopaedic, Scripps Green Hospital — La Jolla, California, United States
• Stanford University — Redwood City, California, United States
• UCSD Department of Orthpaedic Surgery, UCSD Medical Center — San Diego, California, United States
• The Spine Institute, St. John's Health Center — Santa Monica, California, United States
• University of South Florida Department of Neurosurgery, Tampa General Hospital — Tampa, Florida, United States
• Pinnacle Orthopaedics, Wellstone Kennestone Hospital — Marietta, Georgia, United States
• Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center — Joliet, Illinois, United States
• Indiana Center for NeuroSurgery, Indiana Surgery Center East — Indianopolis, Indiana, United States
• Columbia Orthopaedic Group, Boone Hospital Center — Columbia, Missouri, United States
• NWREI (for Ortho Montana) — Billings, Montana, United States
• Buffalo Spine Surgery, Kenmore Mercy — Lockport, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Center for Advanced Orthopaedics, Adena Bone and Joint Center — Chillicothe, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Spine Team Texas, Texas Health Harris Methodist Hospital Southlake — Southlake, Texas, United States
• Winchester Medical Center — Winchester, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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