NCT05379127: CURVE

Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

Status unknown NA Last updated 18 November 2023

What this trial tests

NA trial testing Patient-empowered follow up in Adolescent Idiopathic Scoliosis in 812 participants. Status unknown.

Timeline

17 July 2022

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	812
Start date	17 July 2022
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	23 locations across Netherlands

Drugs / interventions tested

• Patient-empowered follow up
• Standard follow-up

Conditions studied

• Adolescent Idiopathic Scoliosis — all drugs for Adolescent Idiopathic Scoliosis →

Sponsor

Radboud University Medical Center

Who can join

Adults 10 to 18, any sex, with Adolescent Idiopathic Scoliosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation.

Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial \[PRPT\]).

Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included.

Three subgroups of AIS patients are distinguished, which are monitored over two years:

1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
2. Post-brace treatment group (n=122 per arm; total n=244)
3. Post-surgery group (n=152 per arm; total n=304)

Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.
   Baetsen JTF, Hooff ML, Bisseling P, Van Dongen JM, et al · · 2024 · PMID 38888063 · DOI 10.2340/17453674.2024.40904