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

NCT00942045 | Completed

• 1 other identifier: NUVA.OC.0802
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 17

Brief Summary

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).

Conditions

Degenerative Disc Disease in Cervical Spine

Keywords

cervical spine; ACDF; biologics; fusion rates

Outcome Measures

Primary Outcomes (1)

• To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.

  from pre-op to 24-month follow-up

Secondary Outcomes (3)

• To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).

  from pre-op to 24-month follow-up

• To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).

  from pre-op to 24-month post-op

• To evaluate and compare each outcome with respect to surgical time and blood loss.

  from pre-op to 24-month follow-up

Interventions

Biologic - Osteocel Plus BIOLOGICAL

Osteocel Plus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing clinic patients

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
• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (17)

Shiley Center for Orthopaedic, Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

UCSD Department of Orthpaedic Surgery, UCSD Medical Center

San Diego, California, 92103, United States

Location

The Spine Institute, St. John's Health Center

Santa Monica, California, 90404, United States

Location

University of South Florida Department of Neurosurgery, Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Pinnacle Orthopaedics, Wellstone Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

Indiana Center for NeuroSurgery, Indiana Surgery Center East

Indianopolis, Indiana, 46219, United States

Location

Columbia Orthopaedic Group, Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

NWREI (for Ortho Montana)

Billings, Montana, 59101, United States

Location

Buffalo Spine Surgery, Kenmore Mercy

Lockport, New York, 14094, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

The Center for Advanced Orthopaedics, Adena Bone and Joint Center

Chillicothe, Ohio, 45601, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

Spine Team Texas, Texas Health Harris Methodist Hospital Southlake

Southlake, Texas, 76092, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Links

• NuVasive, Inc.

Study Officials

• Kelli Howell, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (17)