Last updated on June 2019

Rampart Duo Clinical (RaDical) Post-Market Study


Brief description of study

This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation will be conducted at up to a maximum of 20 investigation centers with no more than 200 study subjects being enrolled. Data is being collected for patients undergoing a standard of care, on-label, lateral lumbar interbody fusion. The data collected in this evaluation will be used for publication and presentation.

Detailed Study Description

The purpose of this study is to collect data that reports on the clinical outcomes of patients treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels. Data is collected prospectively at specified time points per protocol and includes both objective and subjective measures. Patients will be followed to a maximum of two years.

Clinical Study Identifier: NCT03974711

Find a site near you

Start Over

Spine Institute of Louisiana

Shreveport, LA United States
1.06miles
  Connect »