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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00942045
First received: July 16, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Degenerative Disc Disease in Cervical Spine
Biological: Biologic - Osteocel Plus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes

Resource links provided by NLM:


Further study details as provided by NuVasive:

Primary Outcome Measures:
  • To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP). [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]
  • To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). [ Time Frame: from pre-op to 24-month post-op ] [ Designated as safety issue: No ]
  • To evaluate and compare each outcome with respect to surgical time and blood loss. [ Time Frame: from pre-op to 24-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 182
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Biologic - Osteocel Plus
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Existing clinic patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942045

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

Additional Information:
No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00942045     History of Changes
Other Study ID Numbers: NUVA.OC.0802
Study First Received: July 16, 2009
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuVasive:
cervical spine
ACDF
biologics
fusion rates

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014