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Comparing patient empowerment with standard follow-up for scoliosis

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

Not applicable Interventional Radboud University Medical Center · NCT05379127

This study tests if a new way of involving teens with scoliosis in their own care can help them feel better and manage their condition more effectively compared to standard follow-up visits.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment812 (estimated)
Ages10 Years to 18 Years
SexAll
SponsorRadboud University Medical Center Academic / other
Locations23 sites (Zwolle, Drenthe and 22 other locations)
Trial IDNCT05379127 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and cost-effectiveness of a new patient-empowered follow-up protocol for adolescents with idiopathic scoliosis, using patient-reported outcome measures and self-assessment tools. It compares this approach to standard follow-up care in a multicenter pragmatic randomized trial involving 812 patients aged 10-18 years. The study includes three subgroups: pre-treatment, post-brace treatment, and post-surgery patients, monitored over two years to assess both clinical outcomes and economic implications.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 10-18 years diagnosed with adolescent idiopathic scoliosis who can understand Dutch and provide informed consent.

Not a fit: Patients with scoliosis who are outside the age range or do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient engagement and improve health outcomes for adolescents with scoliosis.

How similar studies have performed: Other studies have shown promising results with patient-empowered approaches in various health conditions, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Zwolle, Drenthe and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Adolescent Idiopathic ScoliosisScoliosisSpineQuality of Health CareCost-Benefit AnalysisPatient ParticipationRadiology
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.