Rampart Duo Clinical (RaDical) Post-Market Study

Spineology

Status: Completed

Conditions: Lumbar Degenerative Disc Disease

Treatments: 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.

Study type: Observational

Funder types: Industry

Identifiers

NCT03974711

62-229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

197 participants in 1 patient group

All study subjects

Description:

Note: No interventions are administered under this evaluation. This is a real-world population. The determination to undergo a lateral lumbar interbody fusion procedure is made outside of this evaluation and is a standard of care, on-label procedure.

Treatment:

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.