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

Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes

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).

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease in Cervical Spine
• Intervention / Treatment: Biological: Biologic - Osteocel Plus

Detailed Description

A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Shiley Center for Orthopaedic, Scripps Green Hospital
    • Redwood City, California, United States, 94063
      • Stanford University
    • San Diego, California, United States, 92103
      • UCSD Department of Orthpaedic Surgery, UCSD Medical Center
    • Santa Monica, California, United States, 90404
      • The Spine Institute, St. John's Health Center
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida Department of Neurosurgery, Tampa General Hospital
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Pinnacle Orthopaedics, Wellstone Kennestone Hospital
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
  • Indiana
    • Indianopolis, Indiana, United States, 46219
      • Indiana Center for NeuroSurgery, Indiana Surgery Center East
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopaedic Group, Boone Hospital Center
  • Montana
    • Billings, Montana, United States, 59101
      • NWREI (for Ortho Montana)
  • New York
    • Lockport, New York, United States, 14094
      • Buffalo Spine Surgery, Kenmore Mercy
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center
  • Ohio
    • Chillicothe, Ohio, United States, 45601
      • The Center for Advanced Orthopaedics, Adena Bone and Joint Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • University of Pennsylvania
  • Texas
    • Southlake, Texas, United States, 76092
      • Spine Team Texas, Texas Health Harris Methodist Hospital Southlake
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Existing clinic patients

Description

Inclusion Criteria:

1. Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
2. Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
4. 18-70 years of age at the date of written informed consent
5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
6. Expected to survive at least 2 years beyond surgery
7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
2. Cervical spine abnormality requiring treatment at more than two levels
3. Systemic or local infection; active or latent
4. Previous failed fusion at the operative level
5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
6. 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)
7. Pregnant, or plans to become pregnant during the study
8. Subject is a prisoner
9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
10. 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
11. Participating in another clinical study at any time during the study participation that would confound study data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 each outcome with respect to surgical time and blood loss.	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

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kelli Howell, MS, NuVasive

Publications and helpful links

Helpful Links

• NuVasive, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (Estimated): July 20, 2009

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ACDF; biologics; cervical spine; fusion rates
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: NUVA.OC.0802