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).
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.
Study Type
OBSERVATIONAL
Enrollment
182
Osteocel Plus
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, United States
Stanford University
Redwood City, California, United States
UCSD Department of Orthpaedic Surgery, UCSD Medical Center
San Diego, California, United States
The Spine Institute, St. John's Health Center
Santa Monica, California, United States
University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, United States
Pinnacle Orthopaedics, Wellstone Kennestone Hospital
Marietta, Georgia, United States
Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
Joliet, Illinois, United States
Indiana Center for NeuroSurgery, Indiana Surgery Center East
Indianopolis, Indiana, United States
Columbia Orthopaedic Group, Boone Hospital Center
Columbia, Missouri, United States
NWREI (for Ortho Montana)
Billings, Montana, United States
...and 7 more locations
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
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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