An interventional study of Patient-empowered follow up and Standard follow-up in Adolescent Idiopathic Scoliosis, sponsored by Radboud University Medical Center. Recruiting at 23 sites in Netherlands. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Health services research
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:
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 812 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Specifically for the pre-treatment group:
Specifically for the post-brace group:
Specifically for the post-surgery group:
Exclusion Criteria:
standard care during follow-up
Other: Standard follow-up
Other: Patient-empowered follow up
The patient-empowered follow-up protocol consists of patient-reported outcome measures (PROMs), self-assessment tools and clinical assessment including physical examination. Radiographs will only be taken when progression of the scoliosis (curve progression) or postoperative complications are suspected based on test results and based on the criteria of so called 'sense of alarm'. Note: Sense of alarm ('niet pluis') is based on any deterioration on the above-mentioned PROMs, self-assessment tool, and clinician-based measurement instruments, which is a signal for the treating physician to consider when a radiograph is appropriate. Sense of alarm is described as any other concern by the orthopaedic surgeon, parent or child which warrants a radiograph. For both the Bunnell Scoliometer (clinical assessment tool) and the Scolioscoop (patient self-assessment tool) a threshold of ≥4° is used.
Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).
The proportion of radiographs that has led to treatment consequences
the proportion will serve as an indication of the sensitivity of the new PE-FU protocol and standard FU protocol. The number of x-rays that has led to treatment will be divided by the total number of x-rays in each subgroup to calculate the primary outcome.
Time frame: 24 months
The safety of the standard and the new protocol
The number of false negative radiological findings with treatment consequences not detected by any of the protocols at the end of the study period. This consists of the proportion of patients with delayed detection of progression or post-operative complications (e.g. a pseudo-arthrosis, curve progression, adding on), which requires treatment or increased vigilance.
Time frame: for pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months
The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.
Time frame: 24 months
The change in readiation exposure
The exposure in the new follow up will be compared to standard care using reference values
Time frame: 24 months
Participants perspective: Numeric pain rating scale [NPRS 0-10]
Numeric rating scale for back pain, score range 0-10, 0 no pain at all and 10 wrost pain imaginable.
Time frame: 24 Months
Participants perspective: condition-specific quality of life [SRS-22r]
Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction.
Time frame: 24 months
Participants perspective: health-related quality of life [EQ5D-5L]
Dutch EQ-5D-5L using the Dutch utility score.
Time frame: 24 months
Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])
Dutch version of the scoliosis appearance questionnaire.
Time frame: 24 months
Global perceirved effect [GPE]
the recovery and statisfaction of the participant during and after treatment.
Time frame: 24 months
educational status
questions related to absence from school, absence from physical education classes, frequency of missing school exams, necessity to repeat a class, support and alternatives provided by the school, and return to school and sport after surgery.
Time frame: 24 months
Self-assessment tool: Scolioscoop
Change in the trunk asymmetry (degrees).
Time frame: or pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months
Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY).
Patient outcome analysis is based on EQ5D-5L.
Time frame: 24 months
Cost-Benefit analysis: Cost analysis
The costs will be assessed from a societal and a healthcare perspective. From the societal perspective, intervention, other healthcare, unpaid productivity, informal care, and absenteeism costs will be included, whereas only costs accruing to the formal Dutch healthcare sector will be included for the healthcare perspective.
Time frame: 24 months
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