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Will answer study question through other research means.
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The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspenâ„¢ Spinous Process Fixation System. The Aspenâ„¢ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspenâ„¢ Spinous Process Fixation System. The Aspenâ„¢ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspen Spinous Process Fixation Device | The Aspen device provides supplemental posterior fixation for fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspen Spinous Process Fixation Device | Device | The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in Oswestry Disability Index (ODI) | baseline to 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Title: Fusion success | 12 Months post-operative | |
| Change in Visual Analogue Scale (VAS) (pain) | Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
Pre-operative
Intra-operative Exclusion
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Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion
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| Name | Affiliation | Role |
|---|---|---|
| Shah | Goodman Campbell brain and Spine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Community Orthopedic Medical Group |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| Neurological status |
motor functions, reflexes, and sensory |
| Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months |
| Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay) | Surgical Visit |
| Pain medication usage | Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months |
| Change in EQ-5D-3L | Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months |
| Change in Zurich Claudication Questionnaire | Baseline, 12 months & 24 months |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Goodman Campbell Brian and Spine | Indianapolis | Indiana | 47905 | United States |
| Buffalo Spine Surgery | Lockport | New York | 14094 | United States |
| Pacific Spine Specialists | Tualatin | Oregon | 97062 | United States |
| D009140 |
| Musculoskeletal Diseases |