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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INFUSE™ Bone Graft/CORNERSTONE-SR™ | Experimental |
| |
| Autogenous bone/CORNERSTONE-SR™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | Fusion is defined as:
| 24 month |
| Pain/Disability Status | 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 | 24 month |
| Neurological Status | Neurological status will be assessed preoperatively and postoperatively using a comprehensive neurological status scale. | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time to fusion | 24 month | |
| Hip (Donor Site) Pain | 24 month | |
| General Health Status (SF-36) |
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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:
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;
No previous surgical intervention at the involved fusion level(s);
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;
Age > 18 years at time of surgery;
Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;
Willingness to comply with study plan and sign the consent form.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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|
| Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™ | Device | Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system. |
|
|
| 24 month |
| Pain Status (neck pain, arm pain) | 24 month |
| Patient Satisfaction | 24 month |
| Patient Global Perceived Effect | 24 month |