INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial
Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the Cornerstone-SR™ Allograft Ring and the ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
1 other identifier
interventional
3
0 countries
N/A
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 with cervical symptomatic degenerative disc disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2002
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 14, 2011
CompletedAugust 2, 2013
December 1, 2011
3 years
December 12, 2011
August 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Success
A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Neck Disability Index) Improvement; 3. maintenance or improvement in neurological status; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
12 month
Secondary Outcomes (5)
Disc Height Measurement
12 month
General Health Status (SF-36)
12 month
Pain Status (neck pain, arm pain)
12 month
Patient Satisfaction
12 month
Patient Global Perceived Effect
12 month
Study Arms (2)
INFUSE™ Bone Graft
EXPERIMENTALAutogenous bone
ACTIVE COMPARATORInterventions
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.
Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 14, 2011
Study Start
April 1, 2002
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
August 2, 2013
Record last verified: 2011-12