NCT05963815

The Spine PROMCO Study

Spine Patient Reported Outcome Measures: a Cohort Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Park Medical centrum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Lumbar Disc Herniation
• Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
OTHER	Spine surgery	Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Timeline

• Start date: 2023-01-13
• Primary completion: 2030-01-13
• Completion: 2030-01-13
• First posted: 2023-07-27
• Last updated: 2023-09-28

Locations

1 site across 1 country: Netherlands