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NCT Number: NCT05963815

The Spine PROMCO Study

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.

Recruiting

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Park Medical Center

Rotterdam, South Holland, 30677 GH, Netherlands

Location status: Recruiting

Location contact

Annegien Boeykens, MD

CONTACT

[email protected]

010 436 1537

Annegien GM Boeykens, MD

SUB_INVESTIGATOR

B.Sanjay Harhangi, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spine surgery

Other

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

Primary outcomes

  1. Pain and functionality - COMI BACK

    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 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.

  2. Health status - EQ5DL

    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 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).

Secondary outcomes

  1. Number of Re-operations

    Time frame: 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.

  2. Complication

    Time frame: 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).

  3. Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annegien Boeykens, MD

CONTACT

[email protected]

010 436 1537

Sponsors and collaborators

Lead sponsor

Park Medical centrum

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

Spine Patient Reported Outcome Measures: a Cohort Observational Study

Acronym: Spine PROMCO

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 27, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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