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
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-005633
Sponsor Protocol Number: 17-005633
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