Study of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the CORNERSTONE-SR™Allograft Ring and ATLANTIS™ Anterior Cervical Plate System in Treatment of Patients With Degenerative Cervical Disc Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Degenerative Cervical Disc Disease
- Sponsor
- Medtronic Spinal and Biologics
- Enrollment
- 33
- Primary Endpoint
- Neurological Status
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
- •C2-C3 disc to C7-Tl disc level(s) of involvement.
- •One or two adjacent levels requiring fusion;
Exclusion Criteria
- •Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
- •Has presence of spinal metastases.
- •Has overt or active bacterial infection, either local or systemic.
- •Has fever (temperature \> 101°F oral) at the time of surgery.
- •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.
Outcomes
Primary Outcomes
Neurological Status
Time Frame: 24 month
Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale.
Pain/Disability Status
Time Frame: 24 month
The self-administered Neck Disability Index will be used. Success for each individual patient will be defined as pain/disability improvement postoperatively according to the following definition: Preoperative Score - Postoperative Score \>= 15
Fusion
Time Frame: 24 month
Fusion is defined as: * No evidence of motion as defined by: less than 4° difference in angular motion between flexion and extension as seen on the lateral flexion/extension radiographs. * No radiolucency greater than 2mm of thickness covering more than 50% of superior or inferior graft surface. * Evidence of bridging trabecular bone.
Secondary Outcomes
- Patient Satisfaction(24 month)
- Hip (Donor Site) Pain(24 month)
- Patient Global Perceived Effect(24 month)
- Time to fusion(24 month)
- General Health Status (SF-36)(24 month)
- Pain Status (neck pain, arm pain)(24 month)