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

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: Completed
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / 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.

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: Observational
• Enrollment (Actual): 197

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline	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	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	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	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-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	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	Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.	Through 12 months postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Outcomes 1 - Radiographic Assessments	Assess for fusion status	Assessed at 12 months postoperative.

Collaborators and Investigators

• Sponsor: Spineology, Inc
• Investigators: Study Chair: Donald Erickson, MD, retired

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): April 21, 2022
• Study Completion (Actual): October 3, 2022

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID 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