Comparing Use of Radiographs Versus Patient Empowerment (CURVE) (CURVE)

November 17, 2023 updated by: Radboud University Medical Center

"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]).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713
        • Recruiting
        • UMC Groningen
        • Contact:
          • C Faber, dr.
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • UMC Utrecht
        • Contact:
          • T Schlösser, dr.
    • Drenthe
      • Zwolle, Drenthe, Netherlands, 8025AB
        • Recruiting
        • Isala
        • Contact:
          • A Mostert, Dr.
    • Flevoland
      • Almere, Flevoland, Netherlands, 1315RA
        • Recruiting
        • Flevo ziekenhuis
        • Contact:
          • B Blom, drs.
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Not yet recruiting
        • Rijnstate
        • Contact:
          • J van Susante
      • Harderwijk, Gelderland, Netherlands, 3844 DG
        • Not yet recruiting
        • St Jansdal
        • Contact:
          • P Lammers, drs.
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229HX
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • P Willems, prof. dr.
      • Venlo, Limburg, Netherlands, 5912
        • Recruiting
        • VieCuri
        • Contact:
          • M Hulsbosch, drs.
    • Noord-Brabant
      • Boxmeer, Noord-Brabant, Netherlands, 5835 DV
        • Recruiting
        • Sint Maartenskliniek
        • Contact:
          • P Bisseling, Dr.
      • Breda, Noord-Brabant, Netherlands, 4818CK
        • Recruiting
        • Amphia
        • Contact:
          • E Hoebink, dr.
      • Tilburg, Noord-Brabant, Netherlands, 5022GC
        • Not yet recruiting
        • ETZ Elisabeth
        • Contact:
          • R Geuze, dr.
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1815JD
        • Not yet recruiting
        • Noordwestziekenhuis groep
        • Contact:
          • H Graat
      • Amsterdam, Noord-Holland, Netherlands, 1091AC
        • Recruiting
        • OLVG
        • Contact:
          • D Kempen, dr.
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Amsterdam UMC
      • Haarlem, Noord-Holland, Netherlands, 2035 RC
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • R Hoogendoorn, dr.
      • Hoorn, Noord-Holland, Netherlands, 1624NP
        • Not yet recruiting
        • Dijklander
        • Contact:
          • E Kraaneveld, drs.
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813TZ
        • Recruiting
        • Meander
        • Contact:
          • T.D. Berendes, dr.
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • Recruiting
        • Juliana Kinderziekenhuis
        • Contact:
          • J van Linge, drs.
      • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
        • Recruiting
        • Albert Schweitzer ziekenhuis
        • Contact:
          • W.J. Marijnissen, dr.
      • Gouda, Zuid-Holland, Netherlands, 2803HH
        • Not yet recruiting
        • Groene Hart Ziekenhuis
        • Contact:
          • P Haen, drs.
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus MC
        • Contact:
          • J Rutgens, dr.
        • Contact:
          • H van West, drs.
      • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
        • Recruiting
        • Maasstad ziekenhuis
        • Contact:
          • W Bakker, drs.
    • Zuid-holland
      • Leiden, Zuid-holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden UMC
        • Contact:
          • P.B. de Witte, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard follow-up
standard care during follow-up
Other: 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).
Experimental: Patient-empowered 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.
Time Frame: 24 months
24 months
The change in readiation exposure
Time Frame: 24 months
The exposure in the new follow up will be compared to standard care using reference values
24 months
Participants perspective: Numeric pain rating scale [NPRS 0-10]
Time Frame: 24 Months
Numeric rating scale for back pain, score range 0-10, 0 no pain at all and 10 wrost pain imaginable.
24 Months
Participants perspective: condition-specific quality of life [SRS-22r]
Time Frame: 24 months
Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction.
24 months
Participants perspective: health-related quality of life [EQ5D-5L]
Time Frame: 24 months
Dutch EQ-5D-5L using the Dutch utility score.
24 months
Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])
Time Frame: 24 months
Dutch version of the scoliosis appearance questionnaire.
24 months
Global perceirved effect [GPE]
Time Frame: 24 months
the recovery and statisfaction of the participant during and after treatment.
24 months
educational status
Time Frame: 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.
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
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
Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY).
Time Frame: 24 months
Patient outcome analysis is based on EQ5D-5L.
24 months
Cost-Benefit analysis: Cost analysis
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

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

Investigators

  • Principal Investigator: Miranda L van Hooff, PhD, Radboud University Medical Center
  • Principal Investigator: Marinus de Kleuver, MD, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80-87600-98-19048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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