Comparing Use of Radiographs Versus Patient Empowerment (CURVE)
- Conditions
- Adolescent Idiopathic Scoliosis
- Interventions
- Other: Standard follow-upOther: Patient-empowered follow up
- Registration Number
- NCT05379127
- Lead Sponsor
- Radboud University Medical Center
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 812
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard follow-up Standard follow-up standard care during follow-up Patient-empowered follow-up Patient-empowered follow up -
- Primary Outcome Measures
Name Time Method The proportion of radiographs that has led to treatment consequences 24 months 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.
- Secondary Outcome Measures
Name Time Method The change in readiation exposure 24 months The exposure in the new follow up will be compared to standard care using reference values
The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol. 24 months Self-assessment tool: Scolioscoop 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 Change in the trunk asymmetry (degrees).
Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ]) 24 months Dutch version of the scoliosis appearance questionnaire.
The safety of the standard and the new protocol 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 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.
Participants perspective: Numeric pain rating scale [NPRS 0-10] 24 Months Numeric rating scale for back pain, score range 0-10, 0 no pain at all and 10 wrost pain imaginable.
Participants perspective: health-related quality of life [EQ5D-5L] 24 months Dutch EQ-5D-5L using the Dutch utility score.
Cost-Benefit analysis: Cost analysis 24 months 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.
educational status 24 months 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.
Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY). 24 months Patient outcome analysis is based on EQ5D-5L.
Global perceirved effect [GPE] 24 months the recovery and statisfaction of the participant during and after treatment.
Participants perspective: condition-specific quality of life [SRS-22r] 24 months Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction.
Trial Locations
- Locations (23)
Viecuri
🇳🇱Venlo, Limburg, Netherlands
OLVG
🇳🇱Amsterdam, Noord-Holland, Netherlands
Flevo ziekenhuis
🇳🇱Almere, Flevoland, Netherlands
Isala
🇳🇱Zwolle, Drenthe, Netherlands
Maastricht UMC+
🇳🇱Maastricht, Limburg, Netherlands
St Jansdal
🇳🇱Harderwijk, Gelderland, Netherlands
Rijnstate
🇳🇱Arnhem, Gelderland, Netherlands
Sint Maartenskliniek
🇳🇱Boxmeer, Noord-Brabant, Netherlands
Amphia
🇳🇱Breda, Noord-Brabant, Netherlands
ETZ Elisabeth
🇳🇱Tilburg, Noord-Brabant, Netherlands
Noordwestziekenhuis groep
🇳🇱Alkmaar, Noord-Holland, Netherlands
Amsterdam UMC
🇳🇱Amsterdam, Noord-Holland, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Noord-Holland, Netherlands
Dijklander
🇳🇱Hoorn, Noord-Holland, Netherlands
Albert Schweitzer ziekenhuis
🇳🇱Dordrecht, Zuid-Holland, Netherlands
Meander
🇳🇱Amersfoort, Utrecht, Netherlands
Juliana kinderziekenhuis
🇳🇱Den Haag, Zuid-Holland, Netherlands
Maasstad ziekenhuis
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Groene Hart ziekenhuis
🇳🇱Gouda, Zuid-Holland, Netherlands
Leiden UMC
🇳🇱Leiden, Zuid-holland, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands