Degenerative Disc Disease in Cervical Spine Clinical Trial
Official title:
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
| Verified date | January 2014 |
| Source | NuVasive |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 182 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | NWREI (for Ortho Montana) | Billings | Montana |
| United States | The Center for Advanced Orthopaedics, Adena Bone and Joint Center | Chillicothe | Ohio |
| United States | Columbia Orthopaedic Group, Boone Hospital Center | Columbia | Missouri |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Indiana Center for NeuroSurgery, Indiana Surgery Center East | Indianopolis | Indiana |
| United States | Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center | Joliet | Illinois |
| United States | Shiley Center for Orthopaedic, Scripps Green Hospital | La Jolla | California |
| United States | Buffalo Spine Surgery, Kenmore Mercy | Lockport | New York |
| United States | Pinnacle Orthopaedics, Wellstone Kennestone Hospital | Marietta | Georgia |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| 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 | Swedish Medical Center | Seattle | Washington |
| United States | Spine Team Texas, Texas Health Harris Methodist Hospital Southlake | Southlake | Texas |
| United States | University of South Florida Department of Neurosurgery, Tampa General Hospital | Tampa | Florida |
| United States | Winchester Medical Center | Winchester | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| NuVasive |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects. | from pre-op to 24-month follow-up | No | |
| Secondary | To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP). | from pre-op to 24-month follow-up | Yes | |
| Secondary | To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain). | from pre-op to 24-month post-op | No | |
| Secondary | To evaluate and compare each outcome with respect to surgical time and blood loss. | from pre-op to 24-month follow-up | Yes |