Actively Recruiting

Age: 18Years - 80Years
All Genders
ID05963815

Spine Patient Reported Outcome Measures: a Cohort Observational Study

Led by Park Medical centrum · Updated on 2023-09-28

4000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Park Medical centrum

Lead Sponsor

E

Erasmus Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting an observational prospective cohort study to evaluate the treatment outcomes of various surgical procedures for degenerative lumbar spine conditions such as herniated disk, spinal canal stenosis, discopathy, and spondylolisthesis. The study aims to assess the effectiveness and value of current surgical treatments by collecting patient-reported outcomes over time. This single-center study plans to enroll patients eligible for elective lumbar spine surgery and monitor them for at least 1.5 years with a goal of high participation rates. Participants will undergo one of several surgical interventions including laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, or spondylodesis. Patients will complete digital surveys before surgery and at multiple time points after surgery: 6 weeks, 6 months, 12 months, 24 months, and 36 months. These surveys include self-reported questionnaires assessing pain, functionality (COMI Back), health status (EQ-5D-5L), complications, re-operations, and satisfaction. Throughout the study, participants will provide data through digital questionnaires at scheduled intervals starting about 2 weeks before surgery and continuing up to 36 months after surgery. Researchers will analyze this information using descriptive statistics, multivariate analysis, and economic evaluation from a societal perspective. The assessments focus on changes in pain, function, health status, re-operation rates, complications, and patient satisfaction, providing comprehensive long-term insight into surgical outcomes for lumbar spine degenerative disorders.

CONDITIONS

Brief Title

The Spine PROMCO Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (MRI) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
  • Elective cases.
  • Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
Not Eligible

You will not qualify if you...

  • 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 malignancies.
  • Patients in a traumatic setting.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surgery

Duration - Single day procedure

Participants undergo elective lumbar spine surgery including procedures such as laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, or spondylodesis.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 36 months post surgery

Participants complete digital surveys including self-reporting questionnaires on pain, functionality, health status, complications, re-operations, and satisfaction at several time points after surgery.

Surveys at baseline (2 weeks pre surgery), and 6 weeks, 6 months, 12 months, 24 months, and 36 months post surgery

Trial Site Locations

Total: 1 location

1

Park Medical Center

Rotterdam, South Holland, Netherlands, 30677 GH

Actively Recruiting

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Research Team

A

Annegien Boeykens, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway.

Margreth Grotle, Milada Cvancarova Småstuen, Olaf Fjeld...

https://pubmed.ncbi.nlm.nih.gov/31375617

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

Anthony L Asher, John Knightly, Praveen V Mummaneni...

https://pubmed.ncbi.nlm.nih.gov/32357320

Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine.

Pravesh S Gadjradj, Timothy C Chin-See-Chong, Daphne Donk...

https://pubmed.ncbi.nlm.nih.gov/35000334

The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity.

A F Mannion, A Vila-Casademunt, M Domingo-Sàbat...

https://pubmed.ncbi.nlm.nih.gov/26519374