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Active, Not Recruiting

NCT Number: NCT04638894

Variability in ASD (Adult Spinal Deformity) Value

The study will examine if variability in created value (outcome/costs) over the care cycle for ASD patients can be explained by patient and treatment characteristics.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

Due to budget restrictions in health care, cost is a major challenge, particularly in chronic disorders affecting the ageing population for which advanced but often expensive medical technologies offer benefit. Stakeholders strive to define, assess and improve the so-called "value in healthcare" to achieve the best outcome at the lowest cost of care.

First and foremost, the investigator will try to examine if we can explain variability in the created value over the care cycle by patient and treatment characteristics. This knowledge can be used to optimize the value for the patients. Also, the investigator will try to compare the psychometric properties between the different versions of value equations, resulting from the use of different outcome tools to measure value.

Adult Spinal Deformity patients can take part in the study. This will be decided by clinical examination and radiographic evaluation and is based on at least one of the following criteria: 1) Coronal spinal curvature ≥20°, 2)Sagittal vertical axis (SVA) >5 cm, 3) Pelvic tilt >25°, 4) Thoracic kyphosis >60°. The patients have to be older than or equal to 18 years old at the time of surgery.

In line with the standard of care, the patients will be seen after 3 months, 6 months, 1 year and 2 years postoperatively. Pre- and post-operatively, questionnaires will be completed by the patients. The patient questionnaires EuroQol 5D (EQ-5D-3L and EQ-5D-5L) , Scoliosis Research Society 22 score (SRS-22), Oswestry disability Index, Core Outcome Measures Index score (COMI) and Work status will be completed by the patients during the baseline visit and on each follow-up moment at 3 months, 6 months, 1 year and 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult Spinal Deformity patients
  • Index Surgery from 15/03/2020 and 15/03/2022
  • Age of 18 years old or older at the moment of the index surgery
  • Patients treated in University Hospitals Leuven
  • Patient has full understanding and is willing to participate (Informed consent)

Exclusion criteria

  • • Patients younger than 18 years old at the moment of index surgery
  • Patients with an index surgery before 15/03/2020
  • Patients treated in other centers outside of University Hospitals Leuven

Treatment and study plan

Surgical treatment of patients with adult spinal deformity

Procedure

Including all surgical interventions for patients with adult spinal deformity.

Primary outcomes

  1. Generic Value

    Time frame: 2 years

    Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs

  2. Disease specific value: Scoliosis Research Society Outcomes Questionnaire (SRS-22)

    Time frame: 2 years

    Disease-specific value, measured via the Scoliosis Research Society Outcomes Questionnaire (SRS-22), divided by costs

  3. Disease specific value: Oswestry Low Back Pain Disability Questionnaire (ODI)

    Time frame: 2 years

    Disease-specific value, measured via the Oswestry Low Back Pain Disability Questionnaire (ODI), divided by costs

  4. Disease specific value: Core Outcome Measures Index (COMI)

    Time frame: 2 years

    Disease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs

Secondary outcomes

  1. Workstatus

    Time frame: 2 years

    Workstatus, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain

  2. Return to work

    Time frame: 2 years

    Return to work, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?

Acronym: VIAV

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2020
Registry last updated
Jul 10, 2026

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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