- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04638894
Variability in ASD (Adult Spinal Deformity) Value (VIAV)
Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Tarasiuk
- Phone Number: 003216 338818
- Email: orthopedie.research@uzleuven.be
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- Recruiting
- UZ Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generic Value
Time Frame: 2 years
|
Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs
|
2 years
|
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
|
2 years
|
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
|
2 years
|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Workstatus
Time Frame: 2 years
|
Workstatus, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
|
2 years
|
Return to work
Time Frame: 2 years
|
Return to work, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lieven Moke, Universitaire Ziekenhuizen KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63875
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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