Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF) (NCT00942045) | Clinical Trial Compass
CompletedNot Applicable
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
United States182 participantsStarted 2009-02
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Patient has a mental or physical condition that would limit the ability to comply with study requirements
What they're measuring
1
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
. 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