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| Name | Class |
|---|---|
| ConfinisCPM | UNKNOWN |
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The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedicle screw system alone |
| ||
| Pedicle screw system with cages |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEO Pedicle Screw System™ | Device | The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient´s function from baseline to 12 months | Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible. | 12 months |
| The rate of cage migration in cage-plus-screw systems. | Defined as posterior movement of the cage past the posterior wall of the vertebral body. | 12 months and 24 months post operatively |
| The rate of pedicle screw loosening in screw only and cage-plus-screw systems. | A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs | 12 months and 24 months post operatively |
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Inclusion criteria:
Exclusion criteria:
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In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2).
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| Name | Affiliation | Role |
|---|---|---|
| David C Noriega, PhD, MD | Spine Center, University Hospital Valladolid, Valladolid, Spain | Principal Investigator |
| Yasser Abdalla, MD | Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch | Sande | 26452 | Germany | |||
| Spine Center, University Hospital Valladolid |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| D013120 | Spinal Cord Neoplasms |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| Neo Cage System™ | Device | Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™ |
|
| Valladolid |
| 47006 |
| Spain |
| D055009 |
| Spondylosis |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |