NCT03974711

Rampart Duo Clinical (RaDical) Post-Market Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: Spineology, Inc · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
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.	There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.

Timeline

• Start date: 2017-10-02
• Primary completion: 2022-04-21
• Completion: 2022-10-03
• First posted: 2019-06-05
• Last updated: 2023-12-01

Locations

10 sites across 1 country: United States