A Study to Collect Clinical Outcomes Data of Patients Treated with the Rampart Duo Device for Lateral Lumbar Interbody Fusion Procedure Performed at One or Two Contiguous Levels

Overview

About this study

The purpose of this minimal risk evaluation is to collect data that reports on the clinical outcomes of patients treated with the Rampart Duo device in an instrumented lateral lumbar interbody fusion procedure performed at one or two contiguous levels. Data obtained will be used to support publication and podium opportunities.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • To participate in this investigation, a study subject shall meet the following inclusion criterion:
    • 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.
  • To be consistent with the cleared indications for this product ensuring it is used in alignment with Standard-of-Care:
    • The patient must be skeletally mature (e.g., minimum age 21 years but not greater than 80 years).
    • The planned lateral interbody fusion with the Spineology Rampart Duo Interbody Spacer is for the treatment of confirmed lumbar degenerative disc disease (DDD) at one-level or two-levels between L2 and L5 with up to a Grade I spondylolisthesis. Lumbar DDD diagnosis confirmation shall be determined by subject history, physical examination, and radiographic imaging.
    • The subject has received at least 6 months of conservative (non-surgical) treatment without sufficient relief from symptoms.

Exclusion Criteria:

  • In the event a candidate meets one or both of the following criteria, they shall be exclude from study participation:
    • Previous fusion procedure or total disc replacement at the operative level(s).
    • Enrolled in a concurrent clinical investigation that may confound the findings of the present evaluation.
  • While not exclusionary criteria, the following items are generally contraindicated in patients undergoing lumbar interbody fusion procedures and accordingly, are being tracked.
    • Active systemic infection or infection local to the surgical site;
    • Active or suspected malignancy;
    • Significant metabolic bone disease (e.g., osteoporosis or osteomalacia) to a degree that would contraindicate spinal instrumentation.
    • Taking medications that are known to potentially interfere with bone or soft tissue healing (e.g., chronic systemic steroids);

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mohamad Bydon, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20387117

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