NCT04638894

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

November 16, 2020

Last Update Submit

March 12, 2026

Conditions

Hospital Costs

Outcome Measures

Primary Outcomes (4)

  • Generic Value

    Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs

    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

    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

    2 years

  • Disease specific value: Core Outcome Measures Index (COMI)

    Disease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs

    2 years

Secondary Outcomes (2)

  • Workstatus

    2 years

  • Return to work

    2 years

Interventions

Surgical treatment of patients with adult spinal deformityPROCEDURE

Including all surgical interventions for patients with adult spinal deformity.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of patients, diagnosed with ASD, with an index surgery between 15 march 2020 and 15 march 2022 at University Hospitals Leuven.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

  • Lieven Moke

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

June 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

BE(1)