Rampart Duo Clinical (RaDical) Post-Market Study

Completed

Conditions studied: Lumbar Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT03974711

Run by

Spineology, Inc

People needed

197

Starts

2017-10-02

Expected to finish

2022-10-03

Last updated by the study team

2023-12-01

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bell Neuroscience Institute/Washington Township Medical Foundation — Fremont, California, United States
• Loma Linda University — Loma Linda, California, United States
• Napa Valley Orthopaedic Medical Group — Napa, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• South Florida Spine & Orthopedics — Coconut Creek, Florida, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Orthopedic Institute of Pennsylvania — Camp Hill, Pennsylvania, United States
• Austin Spine Specialists — Austin, Texas, United States
• Spine Works Institute — North Richland Hills, Texas, United States

Full record on ClinicalTrials.gov

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