INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial
NCT ID: NCT01491477
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
3 participants
INTERVENTIONAL
2002-04-30
2005-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
INFUSE™ Bone Graft
INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
Autogenous bone
Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P01-04
Identifier Type: -
Identifier Source: org_study_id