Clinical trial NCT05963815: The Spine PROMCO Study
Official title: Spine Patient Reported Outcome Measures: a Cohort Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Disc Herniation
Spondylolisthesis
Spinal Stenosis
Keywords: Patient related outcome measures
Prognosis
Degenerative Spine disease
Lead sponsor: Park Medical centrum
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2023-07-27
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Pain and functionality - COMI BACK
timeFrame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
measure: Health status - EQ5DL
timeFrame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
Secondary outcomes:
measure: Number of Re-operations
timeFrame: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
measure: Complication
timeFrame: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
measure: Satisfaction
timeFrame: 6 weeks, 6-12-36 months post surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Park Medical Center
state: Zuid-Holland
Study officials:
References:
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