Clinical trial NCT03974711: Rampart Duo Clinical (RaDical) Post-Market Study
Official title: Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Spineology, Inc
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 197
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Real-world population consistent with cleared labeling for the product.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline
timeFrame: 3 months
measure: Short-term objective 1: New onset of thigh symptoms -- Thigh Neurological Change from Baseline
timeFrame: 3 months
measure: Short-term objective 2: Hospital economics -- Blood Loss
timeFrame: EBL collected at time of surgery.
measure: Short-term objective 2: Hospital economics -- Duration of Surgery
timeFrame: DoS collected at time of surgery.
measure: Short-term objective 2: Hospital economics -- Time-to-Discharge
timeFrame: Perioperative.
measure: Long-term objective 1: Patient Low back pain change over time
timeFrame: Through 12 months postoperative.
measure: Long-term objective 1: Patient Low back function change over time
timeFrame: Through 12 months postoperative.
Secondary outcomes:
measure: Additional Outcomes 1 - Radiographic Assessments
timeFrame: Assessed at 12 months postoperative.
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Bell Neuroscience Institute/Washington Township Medical Foundation
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Napa
country: United States
facility: Napa Valley Orthopaedic Medical Group
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Coconut Creek
country: United States
facility: South Florida Spine & Orthopedics
state: Florida
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Camp Hill
country: United States
facility: Orthopedic Institute of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Austin Spine Specialists
state: Texas
city: North Richland Hills
country: United States
facility: Spine Works Institute
state: Texas
Study officials:
affiliation: Retired
name: Donald Erickson, MD
role: STUDY_CHAIR
References: