Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

"The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"

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.

Inclusion Criteria:

• Patients with adolescent idiopathic scoliosis (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). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
• Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
• A primary coronal curve of 10-25 degree.

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. These patients are not included because of the need to monitor brace therapy with radiographs.
• Patients who have undergone previous spinal surgery and are undergoing revision surgery.
• Skeletally mature patients.