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Rampart Duo Clinical (RaDical) Post-Market Study

NCT03974711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2023-12-01

No results posted yet for this study

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.

Conditions

  • Lumbar Degenerative Disc Disease

Interventions

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.

Sponsors & Collaborators

  • Spineology, Inc

    lead INDUSTRY

Principal Investigators

  • Donald Erickson, MD · Retired

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2022-04-21
Completion
2022-10-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03974711 on ClinicalTrials.gov