INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial

Launched by MEDTRONIC SPINAL AND BIOLOGICS · Dec 13, 2011

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
• • herniated disc;
• • osteophyte formation;
• • decreased disc height;
• • thickening of ligamentous tissue;
• • disc degeneration; and/or
• • facet joint degeneration.
• • 2. Has preoperative Neck Disability Index score \> 30;
• • 3. Has single cervical disc disease level requiring fusion from C2 to C7;
• • 4. No previous surgical intervention at the involved fusion level;
• • 5. Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
• • 6. Is at least 18 years of age, inclusive at time of surgery;
• • 7. If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery;
• • 8. Is willing and able to comply with study plan and sign the consent form.
• Exclusion Criteria:
• • 1. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
• • 2. Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged non-steroidal anti-inflammatory drugs excluding routine perioperative anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
• • 3. Has been previously diagnosed with osteopenia, or osteomalacia.
• • 4. Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility).
• • 1. Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
• • 2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
• • 3. Male over the age of 70.
• • 4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.
• • If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
• • 5. Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.
• • 6. Has overt or active bacterial infection, either local or systemic.
• • 7. Has a documented titanium alloy allergy or intolerance.
• • 8. Is mentally incompetent. If questionable, obtain psychiatric consult.
• • 9. Is a prisoner.
• • 10. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug usage.
• • 11. Has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of spinal fusion surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs.
• • 12. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
• • 13. Has a history of exposure to injectable collagen implants.
• • 14. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
• • 15. Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following rhBMP-2/ACS implantation.
• • 16. Has received any previous exposure to any/all BMP's of either human or animal extraction.