Status:
UNKNOWN
Comparing Use of Radiographs Versus Patient Empowerment (CURVE)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Trialbureau Zorgevaluatie Nederland
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
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 meas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT05379127
Start Date
July 17 2022
End Date
December 31 2025
Last Update
November 18 2023
Active Locations (23)
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1
Isala
Zwolle, Drenthe, Netherlands, 8025AB
2
Flevo ziekenhuis
Almere Stad, Flevoland, Netherlands, 1315RA
3
Rijnstate
Arnhem, Gelderland, Netherlands, 6815 AD
4
St Jansdal
Harderwijk, Gelderland, Netherlands, 3844 DG