Status:
COMPLETED
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease in Cervical Spine
Eligibility:
All Genders
18-70 years
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 co...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00942045
Start Date
February 1 2009
End Date
October 1 2012
Last Update
December 24 2025
Active Locations (17)
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1
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, United States, 92037
2
Stanford University
Redwood City, California, United States, 94063
3
UCSD Department of Orthpaedic Surgery, UCSD Medical Center
San Diego, California, United States, 92103
4
The Spine Institute, St. John's Health Center
Santa Monica, California, United States, 90404