Skip to content

The (cost-)effectiveness of a new patient empowered protocol without routine x-rays for follow-up of adolescent idiopathic scoliosis patients; A pragmatic randomized trial

The (cost-)effectiveness of a new patient empowered protocol without routine x-rays for follow-up of adolescent idiopathic scoliosis patients; A pragmatic randomized trial - CURVE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54187
Enrollment
812
Registered
2021-04-16
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescent idiopathic scoliosis AIS idiopathic scoliosis

Interventions

The new patient-empowered and patient-based FU protocol is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: General - Patients with AIS - Age: 10-18 years old - Patients scheduled for follow up in one of the participating centres - Understanding of the Dutch language - Signed informed consent - Biplanar (Posterior-Anterior [PA] and Lateral) full-spine x-rays within the last 3 months Specifically for the pre-treatment group: - Girls aged

Exclusion criteria

Exclusion criteria: - Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10. - Patients who are undergoing brace treatment - Patients who have undergone previous spinal surgery and are undergoing revision surgery. - Skeletally mature patients.

Design outcomes

Primary

MeasureTime frame
The proportion of x-rays that has led to treatment consequences for each subgroup.

Secondary

MeasureTime frame
(1) the proportion of patients with delayed initiation of (brace or operative) treatment due to non-routine radiographic FU, (2) radiation exposure, (3) costs from healthcare and societal perspective, (4) positive predictive value and interrelation of clinical assessment, PROMs and radiological parameters for initiation of treatment during FU.

Countries

Netherlands

Contacts

Public ContactML Hooff

Radboud Universitair Medisch Centrum

Miranda.vanHooff@radboudumc.nl06-13861876

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026