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Variability in ASD (Adult Spinal Deformity) Value

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04638894
Acronym
VIAV
Enrollment
140
Registered
2020-11-20
Start date
2021-06-01
Completion date
2026-11-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Costs

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURESurgical treatment of patients with adult spinal deformity

Including all surgical interventions for patients with adult spinal deformity.

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Generic Value2 yearsGeneric outcome, measured via the EuroQol 5D (EQ-5D), divided by costs
Disease specific value: Scoliosis Research Society Outcomes Questionnaire (SRS-22)2 yearsDisease-specific value, measured via the Scoliosis Research Society Outcomes Questionnaire (SRS-22), divided by costs
Disease specific value: Oswestry Low Back Pain Disability Questionnaire (ODI)2 yearsDisease-specific value, measured via the Oswestry Low Back Pain Disability Questionnaire (ODI), divided by costs
Disease specific value: Core Outcome Measures Index (COMI)2 yearsDisease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs

Secondary

MeasureTime frameDescription
Workstatus2 yearsWorkstatus, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
Return to work2 yearsReturn to work, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain

Countries

Belgium

Contacts

PRINCIPAL_INVESTIGATORLieven Moke

Universitaire Ziekenhuizen KU Leuven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026