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This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. The evaluation collected data in a real-world patient population and was a data collection initiative only. No patient treatments or care were performed as a component of the protocol. All patient care received was on-label and standard of care for lateral lumbar interbody fusions. The data collected in this evaluation is intended to contribute to the body of literature for lateral lumbar interbody fusions.
The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study subjects | Note: No interventions are administered under this evaluation. This is a real-world population. The determination to undergo a lateral lumbar interbody fusion procedure is made outside of this evaluation and is a standard of care, on-label procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort. | Other | There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline | Change from Baseline anterior thigh pain score through 3-months. Pain assessment captured on 100 mm VAS. A higher VAS score represents a worsening of pain. | 3 months |
| Short-term objective 1: New onset of thigh symptoms -- Thigh Neurological Change from Baseline | Change from baseline in anterior thigh neurological assessment through 3 months. Anterior Thigh Neurological deficit defined as a negative change in strength (hip/flexor weakness) or sensation (anterior thigh). | 3 months |
| Short-term objective 2: Hospital economics -- Blood Loss | Estimated blood loss (EBL) shall be compared to published literature. | EBL collected at time of surgery. |
| Short-term objective 2: Hospital economics -- Duration of Surgery | Duration of surgery (DoS) defined as time from incision to closure shall be compared to published literature. | DoS collected at time of surgery. |
| Short-term objective 2: Hospital economics -- Time-to-Discharge | Time-to-discharge (TTD) defined as time from hospital admission to the time the subject is discharged from the hospital and it shall be compared to published literature. | Perioperative. |
| Long-term objective 1: Patient Low back pain change over time | Pain measured on 100 mm VAS and compared to baseline. | Through 12 months postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Outcomes 1 - Radiographic Assessments | Assess for fusion status | Assessed at 12 months postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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Real-world population consistent with cleared labeling for the product.
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| Name | Affiliation | Role |
|---|---|---|
| Donald Erickson, MD | Retired | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bell Neuroscience Institute/Washington Township Medical Foundation | Fremont | California | 94538 | United States | ||
IPD will be shared with study researchers for purposes of publication and presentation purposes.
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| Long-term objective 1: Patient Low back function change over time | Low back function determined on Oswestry Disability Index (ODI) and compared to baseline. | Through 12 months postoperative. |
| Loma Linda University |
| Loma Linda |
| California |
| 92354 |
| United States |
| Napa Valley Orthopaedic Medical Group | Napa | California | 94558 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20734 | United States |
| South Florida Spine & Orthopedics | Coconut Creek | Florida | 33073 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| Orthopedic Institute of Pennsylvania | Camp Hill | Pennsylvania | 17011 | United States |
| Austin Spine Specialists | Austin | Texas | 78705 | United States |
| Spine Works Institute | North Richland Hills | Texas | 76182 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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