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Rampart Duo Clinical (RaDical) Post-Market Study — RaDical  

Lumbar Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03974711
Study type Observational [Patient Registry]
Source Spineology, Inc
Contact
Status Completed
Phase
Start date October 2, 2017
Completion date October 3, 2022
View Details
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