Observational study on outcomes of lumbar spine surgery
Spine Patient Reported Outcome Measures: a Cohort Observational Study
This study is looking at how well different types of back surgery work for people with issues like herniated disks and spinal stenosis by tracking their pain, function, and satisfaction over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Park Medical centrum Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05963815 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients eligible for elective lumbar spine surgery with confirmed degenerative disorders such as herniated disks, stenosis, or spondylolisthesis.
Not a fit: Patients who cannot read or speak Dutch, or those with traumatic spinal injuries or malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of different surgical approaches for degenerative lumbar spine diseases, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success in evaluating surgical outcomes for similar conditions, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rotterdam, South Holland
- Park Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Annegien Boeykens, MD
- Email: a.boeykens@parkmc.nl
- Phone: 010 436 1537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.