The Spine PROMCO Study

Park Medical centrum

Status: Enrolling

Conditions: Spondylolisthesis; Spinal Stenosis; Lumbar Disc Herniation

Treatments: Other: Spine surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05963815

0000090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,000 participants in 1 patient group

Degenerative spine disorder

Description:

Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.

Treatment:

Other: Spine surgery