Observational study on outcomes of lumbar spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational prospective cohort study aims to evaluate the treatment outcomes of various surgical interventions for degenerative lumbar spine diseases, including herniated disks, spinal stenosis, and spondylolisthesis. Patients eligible for elective lumbar spine surgery will be enrolled and asked to complete digital surveys assessing pain, functionality, disability, health status, re-operations, complications, and satisfaction at multiple time points. The study will utilize descriptive statistics and multivariate analysis, along with an economic evaluation from a societal perspective, to analyze the data collected over a minimum of 1.5 years. The goal is to highlight the effectiveness and value of current surgical treatment programs for these conditions.

Why it matters

Who can join: the full rules

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 malignant- cies.
* Patients in a traumatic setting.

Where it's running

• Park Medical Center
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Annegien Boeykens, MD
• Email: a.boeykens@parkmc.nl
• Phone: 010 436 1537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.