Rampart Duo Clinical (RaDical) Post-Market Study

Spineology, Inc197 enrolled

Overview

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.

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

197

Conditions

Lumbar Degenerative Disc Disease

Interventions

In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.OTHER

There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (10)

Bell Neuroscience Institute/Washington Township Medical Foundation

Fremont, California, United States

Loma Linda University

Loma Linda, California, United States

Napa Valley Orthopaedic Medical Group

Napa, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 3 months

Short-term objective 2: Hospital economics -- Blood Loss

Estimated blood loss (EBL) shall be compared to published literature.

Time frame: 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.

Time frame: 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.

Time frame: Perioperative.

Long-term objective 1: Patient Low back pain change over time

Pain measured on 100 mm VAS and compared to baseline.

Time frame: 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.

Data from ClinicalTrials.gov

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