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The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Back and Leg Pain Patients | Experimental | Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPS™ System | Device | The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Improvement | Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score | 24 months |
| Function Improvement | Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score | 24 months |
| Fusion Prevention | The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | Subjects with no serious device complications as defined in the radiological protocol | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilana Alony, RN | Contact | 972-4-6304487 | ilanaa@hy.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Eyal Behrbalk, MD | Hillel Yaffe Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |