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

Conditions: adolescent idiopathic scoliosis
AIS
10028377

Registration Number: NL-OMON54187

Lead Sponsor: Radboud Universiteit Nijmegen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 812

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 <=14 years (i.e 10-14 years) and boys <16 years (i.e. 10-15
years).
- Girls: pre-menarche up to 6 months post-menarche (to estimate end of
growth)
- A primary coronal curve of 10-25 degrees

Specifically for the post-brace group:
- Patients aged 12-18 years
- Within 3 months after termination of brace treatment
- Minimum of 6 months of brace treatment

Specifically for the post-surgery group:
• Patients aged 12-18 years

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of x-rays that has led to treatment consequences for each<br /><br>subgroup.</p><br>

Secondary Outcome Measures

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