Comparing Use of Radiographs Versus Patient Empowerment (CURVE)
NCT ID: NCT05379127
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
812 participants
INTERVENTIONAL
2022-07-17
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The PRPT consists of three separate randomized controlled trials (RCTs) including patients in the pre-treatment phase, post-brace phase or post-operative phase. Alongside the RCTs prospective preference cohorts are included for each treatment arm (patient empowered follow up \[PE-FU\] or standard follow up \[standard FU\]). In the preference cohorts all patients are monitored who are not willing (i.e. who have a preference for either the standard FU or PE-FU) to be randomized to either treatment arm, but who are still willing to participate in the study. By including preference cohorts the generalizability of study results is studied while the internal validity is assured.
* Half of participants (n=406) allocation: randomized (RCT)
* Half of participants (n=406) allocation: based on preference (preference cohorts)
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Standard follow-up
standard care during follow-up
Standard follow-up
Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).
Patient-empowered follow-up
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.
Interventions
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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.
Standard follow-up
Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
10 Years
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Trialbureau Zorgevaluatie Nederland
UNKNOWN
Nederlandse Orthopaedische Vereniging
UNKNOWN
Vereniging Scoliose Patiënten
UNKNOWN
Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Miranda L van Hooff, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Marinus de Kleuver, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Isala
Zwolle, Drenthe, Netherlands
Flevo ziekenhuis
Almere Stad, Flevoland, Netherlands
Rijnstate
Arnhem, Gelderland, Netherlands
St Jansdal
Harderwijk, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Viecuri
Venlo, Limburg, Netherlands
Sint Maartenskliniek
Boxmeer, North Brabant, Netherlands
Amphia
Breda, North Brabant, Netherlands
ETZ Elisabeth
Tilburg, North Brabant, Netherlands
Noordwestziekenhuis groep
Alkmaar, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Haarlem, North Holland, Netherlands
Dijklander
Hoorn, North Holland, Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, South Holland, Netherlands
Groene Hart ziekenhuis
Gouda, South Holland, Netherlands
Leiden UMC
Leiden, South Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Maasstad ziekenhuis
Rotterdam, South Holland, Netherlands
Juliana kinderziekenhuis
The Hague, South Holland, Netherlands
Meander
Amersfoort, Utrecht, Netherlands
UMC Groningen
Groningen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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A Mostert, Dr.
Role: primary
B Blom, drs.
Role: primary
J van Susante
Role: primary
P Lammers, drs.
Role: primary
P Willems, prof. dr.
Role: primary
M Hulsbosch, drs.
Role: primary
P Bisseling, Dr.
Role: primary
E Hoebink, dr.
Role: primary
R Geuze, dr.
Role: primary
H Graat
Role: primary
D Kempen, dr.
Role: primary
R Hoogendoorn, dr.
Role: primary
E Kraaneveld, drs.
Role: primary
W.J. Marijnissen, dr.
Role: primary
P Haen, drs.
Role: primary
P.B. de Witte, dr.
Role: primary
J Rutgens, dr.
Role: primary
H van West, drs.
Role: backup
W Bakker, drs.
Role: primary
J van Linge, drs.
Role: primary
T.D. Berendes, dr.
Role: primary
C Faber, dr.
Role: primary
T Schlösser, dr.
Role: primary
Other Identifiers
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80-87600-98-19048
Identifier Type: -
Identifier Source: org_study_id
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