NCT04638894

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
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospital Costs

Interventions

Type	Name	Description
PROCEDURE	Surgical treatment of patients with adult spinal deformity	Including all surgical interventions for patients with adult spinal deformity.

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2020-11-20
• Last updated: 2026-03-16

Locations

1 site across 1 country: Belgium