INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial

Completed · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.

Key facts

Study ID

NCT00485173

Run by

Medtronic Spinal and Biologics

People needed

224

Starts

2007-06-01

Expected to finish

2012-06-01

Last updated by the study team

2013-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• INCLUSION:
• Single-level cervical degenerative disc disease (from C3-C7) requiring surgical treatment and involving intractable radiculopathy and/or myelopathy.
• Herniated disc and/or osteophyte formation at the level to be treated that is producing symptomatic nerve root and/or spinal cord compression.
• 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.
• At least 18 years of age and skeletally mature at the time of surgery.
• A preoperative Neck Disability Index (NDI) score ≥30.
• A preoperative neck pain score (pain intensity + pain frequency) ≥8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
• If a female of childbearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery.
• Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

You may not qualify if…

• EXCLUSION:
• A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved level.
• Documented or diagnosed cervical instability at the target level, defined by dynamic (flexion/extension) radiographs.
• Previous surgical intervention at the involved level.
• Any subsequent planned/staged surgical procedure at the involved or adjacent level(s).
• Fused level adjacent to the level to be treated.
• Severe pathology of the facet joints of the involved vertebral bodies.
• Has osteoporosis, osteopenia, or osteomalacia as determined by DEXA scan.
• Presence of active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
• Overt or active bacterial infection, either local or systemic.
• Insulin dependent diabetes.
• Chronic or acute renal failure or prior history of renal disease.
• Documented allergy or intolerance to stainless steel, titanium, titanium alloy, polyetheretherketone (PEEK), or tantalum.
• Is mentally incompetent. (if questionable, obtain psychiatric consult.)
• Is a prisoner.
• Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
• On oral or injectable steroids for 6 weeks or more at the time of enrollment.
• A history of autoimmune disease.
• History of exposure to injectable collagen or silicone implants.
• History of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• Received any previous exposure to any/all BMPs either human or animal extraction.
• History of allergy to bovine products.
• History of any allergy resulting in anaphylaxis.
• History of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta).
• Condition that requires postoperative medications that interfere with the stability of the implant, such as steroids.

Where it is running

• 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

Full record on ClinicalTrials.gov

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