Status:
TERMINATED
INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Degenerative Cervical Disc Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this trial is to evaluate the implant (INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate system) as a method of facilitating spinal fusion in patients ...
Eligibility Criteria
Inclusion
- 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.
- Has preoperative Neck Disability Index score \> 30;
- Has single cervical disc disease level requiring fusion from C2 to C7;
- No previous surgical intervention at the involved fusion level;
- 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;
- Is at least 18 years of age, inclusive at time of surgery;
- If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to use adequate contraception for 1 year following surgery;
- Is willing and able to comply with study plan and sign the consent form.
Exclusion
- Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level.
- 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.
- Has been previously diagnosed with osteopenia, or osteomalacia.
- 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).
- Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
- Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
- Male over the age of 70.
- 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.
- Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.
- Has overt or active bacterial infection, either local or systemic.
- Has a documented titanium alloy allergy or intolerance.
- 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 usage.
- 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.
- Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).
- Has a history of exposure to injectable collagen implants.
- Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen.
- 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.
- Has received any previous exposure to any/all BMP's of either human or animal extraction.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01491477
Start Date
April 1 2002
End Date
April 1 2005
Last Update
August 2 2013
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