The Spine PROMCO Study

Recruiting

• Conditions: Lumbar Disc Herniation; Spondylolisthesis; Spinal Stenosis
• Interventions: Other: Spine surgery

• Registration Number: NCT05963815
• Lead Sponsor: Park Medical centrum

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.

Study Timeline

• Study Start: 2023-01-13
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2030-01-13
• Study Completion: 2030-01-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Degenerative spine disorder	Spine surgery	Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.

Primary Outcome Measures

Name	Time	Method
Health status - EQ5DL	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	The eq-5D-5L (Euroquality 5 domains 5 level) health questionnaire provides a simple descriptive profile and a single index value for health status. The EQ-VAS is part of the EQ-5D-5L and it is a visual scale in which the patient can indicate the perception of their health status at the time of assessment, with 100 being perfect health status and 0 the worst health status. With the EQ-5D-5L we can assess the quality-adjusted life years (QALY).
Pain and functionality - COMI BACK	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	The Core Outcome Measures Index (COMI) Back index score (range 0-10) is calculated by averaging transformed core-item scores from each domain of the five domains: pain symptoms (including NRS-scale), functionality of back, symptom-specific well-being, general well-being, and disability. Although the Oswestry disability index (ODI) is the most commonly used and cited tool, the COMI Back was chosen instead to assess pain intensity, functionality and disability within the study group. The COMI back is relatively short (7 questions), includes the NRS-scale (painscore from 0 (no pain) - 10 (worst possible pain), and has been cross-culturally adapted and validated in several languages, including in Dutch. It is the preferred tool of the Eurospine Registry.

Secondary Outcome Measures

Name	Time	Method
Number of Re-operations	post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery	Re-operation due to a complication or recidive is self-reported and registered in the Electronic medical record.
Complication	post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery	Complications are systematically assessed by self-reported questionnaires (e.g. Cerebro spinal fluid leakage, sensomotoric deficits, incontinence, infections, etc).
Satisfaction	6 weeks, 6-12-36 months post surgery	Patient's satisfaction will be assessed using a 5-point Likert Scale to touch on the subject of: (1) hospital satisfaction, (2) treatment satisfaction, (3) recovery satisfaction and (4) response burden of the study. With 1 being very dissatisfied and 5 very satisfied.

Trial Locations

Locations (1)

Park Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands