The Spine PROMCO Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPark Medical centrum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spine surgery
Other interventionPatients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
Treatment groups
4,000 Participants
are divided into 1 treatment groupGroup A: Degenerative spine disorder1 intervention
Trial outcomes
Primary outcomes
1
Pain and functionality - COMI BACK
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.
Time frame
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 surgery2
Health status - EQ5DL
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).
Time frame
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 surgerySecondary outcomes
1
Number of Re-operations
Re-operation due to a complication or recidive is self-reported and registered in the Electronic medical record.
Time frame
post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery2
Complication
Complications are systematically assessed by self-reported questionnaires (e.g. Cerebro spinal fluid leakage, sensomotoric deficits, incontinence, infections, etc).
Time frame
post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery3
Satisfaction
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.
Time frame
6 weeks, 6-12-36 months post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Park Medical centrum
Lead sponsor
Erasmus Medical Center
Collaborator
Source ClinicalTrials.gov