Rampart Duo Clinical (RaDical) Post-Market Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Other: In this evaluation, no interventions are performed. It is a data collection effort only. The procedure for this study is the data collection effort.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical decision has been made to treat the patient with the Rampart Duo Interbody Spacer prior to enrollment into this research evaluation. This decision is independent (made outside) of the decision to take part in the research. Exclusion Criteria: Previous interbody fusion or total disc replacement at the index level(s). Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All study subjects<br>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. | Other: In this evaluation, no interventions are performed. It is a data collection effort only. The procedure for this study is the data collection effort.<br>* There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Outcomes 1 - Radiographic Assessments | Assess for fusion status | Assessed at 12 months postoperative. |