Hospital CostsVIAVNCT04638894
Variability in ASD (Adult Spinal Deformity) Value
An observational study of Hospital Costs, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Costs
- What is being tested?
- Surgical treatment of patients with adult spinal deformity
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2021to 1 Nov 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of patients, diagnosed with ASD, with an index surgery between 15 march 2020 and 15 march 2022 at University Hospitals Leuven.
Who may be able to join
- 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)
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?
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.
Read the 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.
- Conditions
- Hospital Costs
- Being tested
- Surgical treatment of patients with adult spinal deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of patients with adult spinal deformityProcedure or surgery
Including all surgical interventions for patients with adult spinal deformity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic Value
Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs
Measured: 2 years
Disease specific value: Scoliosis Research Society Outcomes Questionnaire (SRS-22)
Disease-specific value, measured via the Scoliosis Research Society Outcomes Questionnaire (SRS-22), divided by costs
Measured: 2 years
Disease specific value: Oswestry Low Back Pain Disability Questionnaire (ODI)
Disease-specific value, measured via the Oswestry Low Back Pain Disability Questionnaire (ODI), divided by costs
Measured: 2 years
Disease specific value: Core Outcome Measures Index (COMI)
Disease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs
Measured: 2 years
Secondary outcomes (2)
Workstatus
Workstatus, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
Measured: 2 years
Return to work
Return to work, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jun 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital CostsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Moke, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638894
- Sponsor's protocol ID
- S63875
- Acronym
- VIAV
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?
- ClinicalTrials.gov ID
- NCT04638894
- Acronym / sponsor ID
- VIAV / S63875
- Conditions
- Hospital Costs
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of patients, diagnosed with ASD, with an index surgery between 15 march 2020 and 15 march 2022 at University Hospitals Leuven.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- • Patients younger than 18 years old at the moment of index surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatment of patients with adult spinal deformityIncluding all surgical interventions for patients with adult spinal deformity. | Procedure or surgery | – |
Primary outcome
Generic Value
Time frame: 2 years
Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs
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
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
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
2 secondary outcomes
Workstatus
Time frame: 2 years
Return to work
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Moke principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Costs, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic Value (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.