INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
NCT ID: NCT00485173
Last Updated: 2013-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
224 participants
INTERVENTIONAL
2007-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INFUSE® Bone Graft
In this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
All patients enrolled in this study will receive the investigational device.
Interventions
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INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
All patients enrolled in this study will receive the investigational device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
2. Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
3. Unresponsive to non-operative treatment for six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management.
4. At least 18 years of age and skeletally mature at the time of surgery.
5. A preoperative Neck Disability Index (NDI) score ≥30.
6. A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
7. If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
8. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Exclusion Criteria
1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
2. Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
3. Previous surgical intervention at the involved level.
4. Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
5. Fused level adjacent to the level to be treated.
6. Severe pathology of the facet joints of the involved vertebral bodies.
7. Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
8. Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
9. Overt or active bacterial infection, either local or systemic.
10. Insulin dependent diabetes.
11. Chronic or acute renal failure or prior history of renal disease.
12. Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
13. Is mentally incompetent. (if questionable, obtain psychiatric consult.)
14. Is a prisoner.
15. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
16. On oral or injectable steroids for 6 weeks or more at the time of enrollment.
17. A history of autoimmune disease.
18. History of exposure to injectable collagen or silicone implants.
19. History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
20. Received any previous exposure to any/all BMPs either human or animal extraction.
21. History of allergy to bovine products.
22. History of any allergy resulting in anaphylaxis.
23. History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
24. Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.
25. Received treatment with an investigational therapy (drug, device, or biologic) within 28 days prior to implantation surgery or such treatment is planned during the 24-month period following the study surgery.
18 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Locations
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S & B Surgery Center
Beverly Hills, California, United States
Orange County Neurological Association
Laguna Hills, California, United States
Crane Creek Medical Ctr. The Back Center /Osler Medical
Melbourne, Florida, United States
The Hughston Clinic, P.C.
Columbus, Georgia, United States
University of Kansas Medcal Center
Kansas City, Kansas, United States
Spine Institute
Shreveport, Louisiana, United States
Springfield Neurological Institute
Springfield, Missouri, United States
Buffalo Neurosurgery Group
West Seneca, New York, United States
University of Cincinnati Dept of Neurosurgery
Cincinnati, Ohio, United States
TriState Orthopedic Treatment Center
Norwood, Ohio, United States
The Washington Hospital
Washington, Pennsylvania, United States
Center for Sports Medcine & Orthopedics
Chattanooga, Tennessee, United States
Semmes Murphey Neurologic & Spine Institute
Memphis, Tennessee, United States
Central Texas Spine
Austin, Texas, United States
Brain and Spine Center of Texas, L.L.P.
Plano, Texas, United States
Inland Neurosurgery & Spine Associates, P.S.
Spokane, Washington, United States
Countries
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Other Identifiers
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INFUSE® Bone Graft PEEK ACDF
Identifier Type: -
Identifier Source: org_study_id
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