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NCT Number: NCT03974711

Rampart Duo Clinical (RaDical) Post-Market Study

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.

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Key information

Conditions

Lumbar Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bell Neuroscience Institute/Washington Township Medical Foundation, Fremont, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. Additional Outcomes 1 - Radiographic Assessments

    Time frame: Assessed at 12 months postoperative.

    Assess for fusion status

Sponsors and collaborators

Lead sponsor

Spineology, Inc

Industry

Registry information

Official study title

Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes

Acronym: RaDical

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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