Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jun 17:95:298-306.
doi: 10.2340/17453674.2024.40904.

The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol

Jurre T F Baetsen #  1 , Miranda L Hooff #  2 , Pepijn Bisseling  3 , Johanna M Van Dongen  4 , Dineke G Van de Fliert  5 , Eric Hoebink  6 , Diederik H R Kempen  7 , Joost P H J Rutges  8 , Tom P C Schlösser  9 , Hanneke M Van West  8 , Philip J Van der Wees  10 , Paul C Willems  11 , Marinus De Kleuver  2 ; Dutch AIS consortium
Collaborators, Affiliations

The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol

Jurre T F Baetsen et al. Acta Orthop. .

Abstract

Background and purpose: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences.

Methods and analyses: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

PubMed Disclaimer

Figures

Figure 1
Figure 1
CONSORT flow of patients throughout the CURVE study.
Figure 2
Figure 2
Follow-up scheme for each of the 3 predefined subgroups of the current study with timeline, with time in months from inclusion to radiography, monoplanar (posterior-anterior), or biplanar. S-FU = standard follow-up, PE-FU = patient empowered follow-up.
Figure 3
Figure 3
Angle of trunk rotation measurement using the Scolioscope. © Productzaken
See this image and copyright information in PMC

References

    1. Weinstein S L, Dolan L A, Cheng J C, Danielsson A, Morcuende J A. Adolescent idiopathic scoliosis. Lancet 2008; 371(9623): 1527-37. doi: 10.1016/s0140-6736(08)60658-3. - DOI - PubMed
    1. Negrini S, Grivas T B, Kotwicki T, Maruyama T, Rigo M, Weiss H R. Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis 2006; 1:4. doi: 10.1186/1748-7161-1-4. - DOI - PMC - PubMed
    1. de Kleuver M, Lewis S J, Germscheid N M, Kamper S J, Alanay A, Berven S H, et al. . Optimal surgical care for adolescent idiopathic scoliosis: an international consensus. Eur Spine J 2014; 23(12): 2603-18. doi: 10.1007/s00586-014-3356-1. - DOI - PubMed
    1. Negrini S, Aulisa A G, Aulisa L, Circo A B, de Mauroy J C, Durmala J, et al. . 2011 SOSORT guidelines: Orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Dis 2012; 7. doi: 10.1186/1748-7161-7-3. - DOI - PMC - PubMed
    1. Negrini S, Donzelli S, Aulisa A G, Czaprowski D, Schreiber S, de Mauroy J C, et al. . 2016 SOSORT guidelines: Orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Dis 2018; 13. doi: 10.1186/s13013-017-0145-8. - DOI - PMC - PubMed

Publication types