Rampart Duo Clinical (RaDical) Post-Market Study (RaDical)

November 27, 2023 updated by: Spineology, Inc

Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Bell Neuroscience Institute/Washington Township Medical Foundation
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Napa, California, United States, 94558
        • Napa Valley Orthopaedic Medical Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20734
        • Georgetown University Hospital
    • Florida
      • Coconut Creek, Florida, United States, 33073
        • South Florida Spine & Orthopedics
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Orthopaedic Institute of Western Kentucky
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Orthopedic Institute of Pennsylvania
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Spine Specialists
      • North Richland Hills, Texas, United States, 76182
        • Spine Works Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Real-world population consistent with cleared labeling for the product.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline
Time Frame: 3 months
Change from Baseline anterior thigh pain score through 3-months. Pain assessment captured on 100 mm VAS. A higher VAS score represents a worsening of pain.
3 months
Short-term objective 1: New onset of thigh symptoms -- Thigh Neurological Change from Baseline
Time Frame: 3 months
Change from baseline in anterior thigh neurological assessment through 3 months. Anterior Thigh Neurological deficit defined as a negative change in strength (hip/flexor weakness) or sensation (anterior thigh).
3 months
Short-term objective 2: Hospital economics -- Blood Loss
Time Frame: EBL collected at time of surgery.
Estimated blood loss (EBL) shall be compared to published literature.
EBL collected at time of surgery.
Short-term objective 2: Hospital economics -- Duration of Surgery
Time Frame: DoS collected at time of surgery.
Duration of surgery (DoS) defined as time from incision to closure shall be compared to published literature.
DoS collected at time of surgery.
Short-term objective 2: Hospital economics -- Time-to-Discharge
Time Frame: Perioperative.
Time-to-discharge (TTD) defined as time from hospital admission to the time the subject is discharged from the hospital and it shall be compared to published literature.
Perioperative.
Long-term objective 1: Patient Low back pain change over time
Time Frame: Through 12 months postoperative.
Pain measured on 100 mm VAS and compared to baseline.
Through 12 months postoperative.
Long-term objective 1: Patient Low back function change over time
Time Frame: Through 12 months postoperative.
Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.
Through 12 months postoperative.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additional Outcomes 1 - Radiographic Assessments
Time Frame: Assessed at 12 months postoperative.
Assess for fusion status
Assessed at 12 months postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spineology, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Donald Erickson, MD, retired

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 62-229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be shared with study researchers for purposes of publication and presentation purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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