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Rampart Duo Clinical (RaDical) Post-Market Study

NCT ID: NCT03974711

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2022-10-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All study subjects

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.

In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.

Intervention Type OTHER

There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spineology, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald Erickson, MD

Role: STUDY_CHAIR

Retired

Locations

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Bell Neuroscience Institute/Washington Township Medical Foundation

Fremont, California, United States

Site Status

Loma Linda University

Loma Linda, California, United States

Site Status

Napa Valley Orthopaedic Medical Group

Napa, California, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

South Florida Spine & Orthopedics

Coconut Creek, Florida, United States

Site Status

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

Site Status

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Site Status

Orthopedic Institute of Pennsylvania

Camp Hill, Pennsylvania, United States

Site Status

Austin Spine Specialists

Austin, Texas, United States

Site Status

Spine Works Institute

North Richland Hills, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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62-229

Identifier Type: -

Identifier Source: org_study_id