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A study across several schools to see if screening teenagers for early signs of scoliosis is useful and affordable: ScolioScreen

A multicenter, schoolbased cluster randomized trial evaluating the (cost-) efficacy of preventative school screening for early detection of adolescent idiopathic scoliosis: ScolioScreen - ScolioScreen

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58120
Enrollment
20000
Registered
2025-07-28
Start date
2025-11-11
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis, idiopathic scoliosis Curved spine, Sideways curve of the spine

Interventions

InterventionsSchools will be randomized equally into an intervention group with school-based scoliosis screening and a control group without or with limited screening.Intervention Group:Screening targ
45°). Progression leads to treatment escalation.Consent and Withdrawal: Digital informed consent is obtained from caregivers and patients &gt
12 years. Participation is voluntary
withdrawal is allowed anytime.&nbsp

Sponsors

Maastricht Universitair Medisch Centrum +
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Schools eligible for the trial must offer Youth Health Care and be willing to participate and facilitate scoliosis screening. In order to be eligible to participate in this study, individual subjects should fall within the age range of 10 to 14 years and should be enrolled in regional primary or secondary schools operating under the jurisdiction of the municipal health services of Noord-Limburg, Zuid- Limburg, or Brabant-Zuidoost regions.  

Exclusion criteria

Exclusion criteria: Age limitation: Individuals outside the specified age range of 10 to 14 years are ineligible for participation.Non-idiopathic scoliosis: Individuals presenting with scoliosis of non-idiopathic origin, such as congenital or neuromuscular scoliosis, do not meet the inclusion criteria.Children already diagnosed with adolescent idiopathic scoliosis (AIS) who are currently under treatment or follow-up by an orthopedic surgeon.Absence on the day of the school screening.Refusal to participate, including those who have unsubscribed through the opt-out procedure or actively refuse participation during the school screening.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the effectiveness of school-based scoliosis screening in preventing progression of scoliotic curves to the surgical threshold (=45 degrees) in adolescents with AIS. The key metric is the proportion of participants whose curve exceeds this threshold by skeletal maturity. Assessment occurs at the end of individual growth and at study completion.

Secondary

MeasureTime frame
Impact on Referral Rate to Orthopedic Surgeons This secondary outcome evaluates how school-based scoliosis screening affects the overall referral rate to orthopedic surgeons. The absolute number and proportion of referrals among screened adolescents will be measured at study end and compared to historical/control data to assess the screening’s influence on demand for specialized care.Scoliosis Among Trunk Asymmetry Cases This parameter investigates the relationship between trunk asymmetry and confirmed scoliosis, especially in younger children. It quantifies the proportion of children with trunk asymmetry who also have scoliosis, providing insight into the diagnostic accuracy of trunk asymmetry as a screening indicator. Assessment will occur at study completion.Economic Evaluation A combined cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will be performed. The Incremental Cost-Effectiveness Ratio (ICER) will express incremental costs per screening. The primary CUA outcome is quality-adjusted life years (QALYs), derived from EuroQol utility scores.

Countries

Netherlands

Contacts

Public ContactE Jacobs

Maastricht Universitair Medisch Centrum +

scolioscreen.orthopedie@mumc.nl043 387 7144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)