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

NCT ID: NCT00942045

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Degenerative Disc Disease in Cervical Spine

Keywords

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cervical spine ACDF biologics fusion rates

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biologic - Osteocel Plus

Osteocel Plus

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NuVasive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelli Howell, MS

Role: STUDY_DIRECTOR

NuVasive

Locations

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Shiley Center for Orthopaedic, Scripps Green Hospital

La Jolla, California, United States

Site Status

Stanford University

Redwood City, California, United States

Site Status

UCSD Department of Orthpaedic Surgery, UCSD Medical Center

San Diego, California, United States

Site Status

The Spine Institute, St. John's Health Center

Santa Monica, California, United States

Site Status

University of South Florida Department of Neurosurgery, Tampa General Hospital

Tampa, Florida, United States

Site Status

Pinnacle Orthopaedics, Wellstone Kennestone Hospital

Marietta, Georgia, United States

Site Status

Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center

Joliet, Illinois, United States

Site Status

Indiana Center for NeuroSurgery, Indiana Surgery Center East

Indianopolis, Indiana, United States

Site Status

Columbia Orthopaedic Group, Boone Hospital Center

Columbia, Missouri, United States

Site Status

NWREI (for Ortho Montana)

Billings, Montana, United States

Site Status

Buffalo Spine Surgery, Kenmore Mercy

Lockport, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

The Center for Advanced Orthopaedics, Adena Bone and Joint Center

Chillicothe, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Spine Team Texas, Texas Health Harris Methodist Hospital Southlake

Southlake, Texas, United States

Site Status

Winchester Medical Center

Winchester, Virginia, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.nuvasive.com

NuVasive, Inc.

Other Identifiers

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NUVA.OC.0802

Identifier Type: -

Identifier Source: org_study_id