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| Name | Class |
|---|---|
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMAâ„¢ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single prospective study | Other | All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: EVOS Lumbar Interbody System (EVOS-HA) | Device | All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Interbody fusion rate | Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is graded along the superior and inferior interfaces separately in 25% increments. | 6 months post - operatively |
| Measure | Description | Time Frame |
|---|---|---|
| To measure how much pain the subject is in according to a pain scale - 0-10 | Visual Analogue Scale for back and leg - 0 - 10 cm (no pain - worst possible pain) | 6 weeks, 3, 6, 12 and 24 months post operatively |
| To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kurd, M.D. | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | United States | ||
| Thomas Jefferson University Hospital |
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All subjects will be recruited and receive the EVOS-HA prospectively.
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Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarized into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0 to 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively |
| Functional Impairment | Questionnaire ODI ( Oswestry Disability Index) - disability questionnaire uses to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand sleep, travel graded by score of 0-100 (0 = no disability and 100- maximum disability possible) | pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D008224 | Lymphoma, Follicular |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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