Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04638894 |
| Other study ID # |
S63875 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Anna Tarasiuk |
| Phone |
003216 338818 |
| Email |
orthopedie.research[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
