Adolescent Idiopathic ScoliosisCURVENCT05379127
Comparing Use of Radiographs Versus Patient Empowerment (CURVE)
A study testing Patient-empowered follow up and Standard follow-up in people with Adolescent Idiopathic Scoliosis, run by Radboud University Medical Center at 23 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Patient-empowered follow up and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 23 sitesNetherlands
- Study dates
- 17 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 16Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Netherlands23 sites, 23 recruiting
- Not yet recruiting
Noordwestziekenhuis groep
Alkmaar, North Holland, 1815JD
H Graat
- Recruiting
Flevo ziekenhuis
Almere Stad, Flevoland, 1315RA
B Blom, drs.
- Recruiting
Meander
Amersfoort, Utrecht, 3813TZ
T.D. Berendes, dr.
- Recruiting
OLVG
Amsterdam, North Holland, 1091AC
D Kempen, dr.
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
- Not yet recruiting
Rijnstate
Arnhem, Gelderland, 6815 AD
J van Susante
- Recruiting
Sint Maartenskliniek
Boxmeer, North Brabant, 5835 DV
P Bisseling, Dr.
- Recruiting
Amphia
Breda, North Brabant, 4818CK
E Hoebink, dr.
- Recruiting
Albert Schweitzer ziekenhuis
Dordrecht, South Holland, 3318 AT
W.J. Marijnissen, dr.
- Not yet recruiting
Groene Hart ziekenhuis
Gouda, South Holland, 2803HH
P Haen, drs.
- Recruiting
UMC Groningen
Groningen, 9713
C Faber, dr.
- Recruiting
Spaarne Gasthuis
Haarlem, North Holland, 2035 RC
R Hoogendoorn, dr.
- Not yet recruiting
St Jansdal
Harderwijk, Gelderland, 3844 DG
P Lammers, drs.
- Not yet recruiting
Dijklander
Hoorn, North Holland, 1624NP
E Kraaneveld, drs.
- Recruiting
Leiden UMC
Leiden, South Holland, 2333ZA
P.B. de Witte, dr.
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6229HX
P Willems, prof. dr.
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
J Rutgens, dr.
H van West, drs.
- Recruiting
Maasstad ziekenhuis
Rotterdam, South Holland, 3079 DZ
W Bakker, drs.
- Recruiting
Juliana kinderziekenhuis
The Hague, South Holland, 2545 AA
J van Linge, drs.
- Not yet recruiting
ETZ Elisabeth
Tilburg, North Brabant, 5022GC
R Geuze, dr.
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
T Schlösser, dr.
- Recruiting
Viecuri
Venlo, Limburg, 5912
M Hulsbosch, drs.
- Recruiting
Isala
Zwolle, Drenthe, 8025AB
A Mostert, Dr.
About this study
Official title: "The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"
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]).
Read more
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:
- Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
- Post-brace treatment group (n=122 per arm; total n=244)
- 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Patient-empowered follow up, Standard follow-up
- Keywords
- Scoliosis, Spine, Quality of Health Care, Cost-Benefit Analysis, Patient Participation, Radiology
- Medical subject headings
- Scoliosis, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-empowered follow upOther
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-upOther
Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).
| Study group | Role | What they receive |
|---|---|---|
| Standard follow-up | Other | standard care during follow-up Receives: Other: Standard follow-up |
| Patient-empowered follow-up | Experimental | Not described Receives: Other: Patient-empowered follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 24 months
The change in readiation exposure
The exposure in the new follow up will be compared to standard care using reference values
Measured: 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.
Measured: 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.
Measured: 24 months
Participants perspective: health-related quality of life [EQ5D-5L]
Dutch EQ-5D-5L using the Dutch utility score.
Measured: 24 months
Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])
Dutch version of the scoliosis appearance questionnaire.
Measured: 24 months
Global perceirved effect [GPE]
the recovery and statisfaction of the participant during and after treatment.
Measured: 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.
Measured: 24 months
Self-assessment tool: Scolioscoop
Change in the trunk asymmetry (degrees).
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start17 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial; PRPT). 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Trialbureau Zorgevaluatie Nederland, Nederlandse Orthopaedische Vereniging, Vereniging Scoliose Patiënten, Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium
- Responsible party
- Sponsor
- Investigators
- Miranda L van Hooff, PhD, Principal investigator, Radboud University Medical CenterMarinus de Kleuver, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379127
- Sponsor's protocol ID
- 80-87600-98-19048
- Acronym
- CURVE
- Status last verified
- Nov 2023
- First submitted
- 6 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"
- ClinicalTrials.gov ID
- NCT05379127
- Acronym / sponsor ID
- CURVE / 80-87600-98-19048
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Scoliosis, Spine, Quality of Health Care, Cost-Benefit Analysis, Patient Participation, Radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 812 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Trialbureau Zorgevaluatie Nederland, Nederlandse Orthopaedische Vereniging, Vereniging Scoliose Patiënten, Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
- Post-brace treatment group (n=122 per arm; total n=244)
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial; PRPT). 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)
| Arm | Type | Receives |
|---|---|---|
| Standard follow-up | Other | Other: Standard follow-upstandard care during follow-up |
| Patient-empowered follow-up | Experimental | Other: Patient-empowered follow up |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-empowered follow upThe 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. | Other | Patient-empowered follow-up |
| Standard follow-upRoutine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications). | Other | Standard follow-up |
Primary outcome
The proportion of radiographs that has led to treatment consequences
Time frame: 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.
12 secondary outcomes
The safety of the standard and the new protocol
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
Time frame: 24 months
Participants perspective: Numeric pain rating scale [NPRS 0-10]
Time frame: 24 Months
Participants perspective: condition-specific quality of life [SRS-22r]
Time frame: 24 months
Participants perspective: health-related quality of life [EQ5D-5L]
Time frame: 24 months
Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])
Time frame: 24 months
Global perceirved effect [GPE]
Time frame: 24 months
educational status
Time frame: 24 months
Self-assessment tool: Scolioscoop
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).
Time frame: 24 months
Cost-Benefit analysis: Cost analysis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miranda L van Hooff, PhD principal investigator
Radboud University Medical Center
Marinus de Kleuver, MD, PhD principal investigator
Radboud University Medical Center
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-empowered follow up and Standard follow-up in people with Adolescent Idiopathic Scoliosis, run by Radboud University Medical Center at 23 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miranda L van Hooff, PhD (+31 24 361 3366, Miranda.vanHooff@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of radiographs that has led to treatment consequences (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.