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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 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: 1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264) 2. Post-brace treatment group (n=122 per arm; total n=244) 3. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Noordwestziekenhuis groep
NOT_YET_RECRUITING
Alkmaar
Flevo ziekenhuis
RECRUITING
Almere Stad
Meander
RECRUITING
Amersfoort
Amsterdam UMC
RECRUITING
Amsterdam
OLVG
RECRUITING
Amsterdam
Rijnstate
NOT_YET_RECRUITING
Arnhem
Sint Maartenskliniek
RECRUITING
Boxmeer
Amphia
RECRUITING
Breda
Albert Schweitzer ziekenhuis
RECRUITING
Dordrecht
Groene Hart ziekenhuis
NOT_YET_RECRUITING
Gouda
UMC Groningen
RECRUITING
Groningen
Spaarne Gasthuis
RECRUITING
Haarlem
St Jansdal
NOT_YET_RECRUITING
Harderwijk
Dijklander
NOT_YET_RECRUITING
Hoorn
Leiden UMC
RECRUITING
Leiden
Maastricht UMC+
RECRUITING
Maastricht
Erasmus MC
RECRUITING
Rotterdam
Maasstad ziekenhuis
RECRUITING
Rotterdam
Juliana kinderziekenhuis
RECRUITING
The Hague
ETZ Elisabeth
NOT_YET_RECRUITING
Tilburg
UMC Utrecht
RECRUITING
Utrecht
Viecuri
RECRUITING
Venlo
Isala
RECRUITING
Zwolle
Contact Information
Primary
Miranda L van Hooff, PhD
Miranda.vanHooff@radboudumc.nl
+31 24 361 3366
Backup
Jurre Baetsen, MSc
Jurre.Baetsen@radboudumc.nl
+31 6 55742308
Time Frame
Start Date: 2022-07-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 812
Treatments
Other: Standard follow-up
standard care during follow-up
Experimental: Patient-empowered follow-up
Sponsors
Collaborators: Vereniging Scoliose Patiënten, Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium, Nederlandse Orthopaedische Vereniging, Trialbureau Zorgevaluatie Nederland, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov