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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05963815
Study type Observational
Source Park Medical centrum
Contact Annegien Boeykens, MD
Phone 010 436 1537
Email a.boeykens@parkmc.nl
Status Recruiting
Phase
Start date January 13, 2023
Completion date January 13, 2030

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