The Spine PROMCO Study: a Cohort Observational Study

Sponsor

Park Medical centrum (Other)

Overall Status

Recruiting

CT.gov ID

NCT05963815

Collaborator

Erasmus Medical Center (Other)

4,000

Enrollment

Location

Anticipated Duration (Months)

47.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation Spondylolisthesis Spinal Stenosis	Other: Spine surgery

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). We pursue an enrolment rate of at least 80% within 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

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Spine Patient Reported Outcome Measures: a Cohort Observational Study

Actual Study Start Date :

Jan 13, 2023

Anticipated Primary Completion Date :

Jan 13, 2030

Anticipated Study Completion Date :

Jan 13, 2030

Arms and Interventions

Arm	Intervention/Treatment
Degenerative spine disorder Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.	Other: Spine surgery Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Arm

Intervention/Treatment

Degenerative spine disorder

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

Other: Spine surgery

Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Outcome Measures

Primary Outcome Measures

Patient related outcome Measures [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]
PROMs will be collected using validated questionnaires that pertain to different domains: (1) pain intensity, (2) functionality, (3) disability, (4) health related quality of life, and (5) patient satisfaction. This prospective cohort study uses a set of outcome metrics in accordance with the ICHOMs recommendations for low back pain (cite). Including: COMI BACK, EQ5D5L

Secondary Outcome Measures

Clinical outcome [post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery]
Re-operation and complications are systematically assessed by self-reported questionnaires (e.g. liquor leakage, sensomotoric deficits, incontinence, infections, etc).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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.