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The Spine PROMCO Study

The Spine PROMCO Study

Recruiting
18-80 years
All
Phase N/A

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Overview

Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.

Description

This observational prospective unicenter cohort study includes patients who are eligible for elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk, spinal canal stenosis, discopathy and spondylolisthesis). An enrolment rate of at least 80% is pursued within minimal 1.5 years of inclusion. A digital survey is used including self-reporting questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back), health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis, an economic evaluation will be performed from a societal perspective.

Eligibility

Inclusion Criteria:

  • All patients who are eligible for elective surgery of the lumbar spine.
  • All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
  • Patients must be able to fill in the questionnaire online
  • Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
  • Elective cases
  • Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Exclusion Criteria:

  • Patients who cannot speak nor read the Dutch language
  • Patients who are not able to complete the digital questionnaires, according to the including doctor
  • Patients with fractures, primary infections of the spine, or with spinal malignantcies.
  • Patients in a traumatic setting.

Study details
    Lumbar Disc Herniation
    Spondylolisthesis
    Spinal Stenosis

NCT05963815

Park Medical centrum

28 January 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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