Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
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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).
Condition or disease
Degenerative Disc Disease in Cervical Spine
Biological: Biologic - Osteocel Plus
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.
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 ]
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 ]
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). [ Time Frame: from pre-op to 24-month post-op ]
To evaluate and compare each outcome with respect to surgical time and blood loss. [ Time Frame: from pre-op to 24-month follow-up ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Existing clinic patients
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
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