Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Spineology, Inc
- Enrollment
- 197
- Locations
- 10
- Primary Endpoint
- Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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).
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.
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.
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.
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.
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.
Secondary Outcomes
- Additional Outcomes 1 - Radiographic Assessments(Assessed at 12 months postoperative.)