Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · May 12, 2022

Keywords

ClinConnect Summary

The CURVE trial is studying a new way to follow up with teenagers who have Adolescent Idiopathic Scoliosis (AIS), a condition where the spine curves abnormally. Instead of relying on routine X-rays to monitor their progress, this trial will compare a patient-focused approach that includes self-assessment tools and physical exams with the standard care, which involves regular X-rays. The goal is to find out if this new method is effective and cost-efficient, while also ensuring that patients feel more involved in their own care.

To participate in the trial, you must be between 10 and 18 years old and have AIS. You should have had a recent full-spine X-ray and be fluent in Dutch. The study will include different groups of patients: those who are just starting treatment, those who have recently finished wearing a brace, and those who have had surgery. Participants will be monitored over two years, and while you may not have to take X-rays regularly, they will be done if any issues arise. This trial is a great opportunity to help shape future care for AIS patients, making it more patient-centered.

Gender

ALL

Eligibility criteria

• 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.