Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

Adolescent Idiopathic Scoliosis Clinical Trial

— CURVE  

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379127
• Other study ID #: 80-87600-98-19048
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: Miranda L van Hooff, PhD
• Phone: +31 24 361 3366
• Email: Miranda.vanHooff[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 812
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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).

Locations

Country	Name	City	State
Netherlands	Noordwestziekenhuis groep	Alkmaar	Noord-Holland
Netherlands	Flevo ziekenhuis	Almere	Flevoland
Netherlands	Meander	Amersfoort	Utrecht
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
Netherlands	OLVG	Amsterdam	Noord-Holland
Netherlands	Rijnstate	Arnhem	Gelderland
Netherlands	Sint Maartenskliniek	Boxmeer	Noord-Brabant
Netherlands	Amphia	Breda	Noord-Brabant
Netherlands	Juliana kinderziekenhuis	Den Haag	Zuid-Holland
Netherlands	Albert Schweitzer ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	Groene Hart ziekenhuis	Gouda	Zuid-Holland
Netherlands	UMC Groningen	Groningen
Netherlands	Spaarne Gasthuis	Haarlem	Noord-Holland
Netherlands	St Jansdal	Harderwijk	Gelderland
Netherlands	Dijklander	Hoorn	Noord-Holland
Netherlands	Leiden UMC	Leiden	Zuid-holland
Netherlands	Maastricht UMC+	Maastricht	Limburg
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	Maasstad ziekenhuis	Rotterdam	Zuid-Holland
Netherlands	ETZ Elisabeth	Tilburg	Noord-Brabant
Netherlands	UMC Utrecht	Utrecht
Netherlands	Viecuri	Venlo	Limburg
Netherlands	Isala	Zwolle	Drenthe

Sponsors (6)

Lead Sponsor	Collaborator
Radboud University Medical Center	Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium, Nederlandse Orthopaedische Vereniging, Trialbureau Zorgevaluatie Nederland, Vereniging Scoliose Patiënten, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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.	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
Secondary	The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.		24 months
Secondary	The change in readiation exposure	The exposure in the new follow up will be compared to standard care using reference values	24 months
Secondary	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.	24 Months
Secondary	Participants perspective: condition-specific quality of life [SRS-22r]	Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction.	24 months
Secondary	Participants perspective: health-related quality of life [EQ5D-5L]	Dutch EQ-5D-5L using the Dutch utility score.	24 months
Secondary	Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])	Dutch version of the scoliosis appearance questionnaire.	24 months
Secondary	Global perceirved effect [GPE]	the recovery and statisfaction of the participant during and after treatment.	24 months
Secondary	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.	24 months
Secondary	Self-assessment tool: Scolioscoop	Change in the trunk asymmetry (degrees).	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
Secondary	Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY).	Patient outcome analysis is based on EQ5D-5L.	24 months
Secondary	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.	24 months