Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

Radboud University Medical Center

Status

Enrolling

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Other: Standard follow-up

Other: Patient-empowered follow up

Study type

Interventional

Funder types

Other

Identifiers

NCT05379127

80-87600-98-19048

Details and patient eligibility

About

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:

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

Enrollment

812 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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.