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Contraindications to magnetically controlled growing rods: consensus among experts in treating early onset scoliosis

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Abstract

Purpose

The purpose of this study was to describe contraindications to the magnetically controlled growing rod (MCGR) in patients with early onset scoliosis (EOS) by establishing consensus amongst expert surgeons who treat these patients frequently.

Methods

Nine pediatric spine surgeons from an international EOS study group participated in semi-structured interviews via email to identify factors that influence decision making in the use of MCGR. A 39-question survey was then developed to specify these factors as contraindications for MCGR—these included patient age and size, etiology, medical comorbidities, coronal and sagittal curve profiles, and skin and soft tissue characteristics. Pediatric spine surgeons from the EOS international study group were invited to complete the survey. A second 29-item survey was created to determine details and clarify results from the first survey. Responses were analyzed for consensus (> 70%), near consensus (60–69%), and no consensus/variability (< 60%) for MCGR contraindication.

Results

56 surgeons of 173 invited (32%) completed the first survey, and 64 (37%) completed the second survey. Responders had a mean of over 15 years in practice (range 1–45) with over 6 years of experience with using MCGR (range 2–12). 71.4% of respondents agreed that patient size characteristics should be considered as contraindications, including BMI (81.3%) and spinal height (84.4%), although a specific BMI range or a specific minimum spinal height were not agreed upon. Among surgeons who agreed that skin and soft tissue problems were contraindications (78.6%), insufficient soft tissue (98%) and skin (89%) to cover MCGR were specified. Among surgeons who reported curve stiffness as a contraindication (85.9%), there was agreement that this curve stiffness should be defined by clinical evaluation (78.2%) and by traction films (72.3%). Among surgeons who reported sagittal curve characteristics as contraindications, hyperkyphosis (95.3%) and sagittal curve apex above T3 (70%) were specified. Surgeons who indicated the need for repetitive MRI as a contraindication (79.7%) agreed that image quality (72.9%) and not patient safety (13.6%) was the concern. In the entire cohort, consensus was not achieved on the following factors: patient age (57.4%), medical comorbidities (46.4%), etiology (53.6%), and coronal curve characteristics (58.9%).

Conclusion

Surgeon consensus suggests that MCGR should be avoided in patients who have insufficient spinal height to accommodate the MCGR, have potential skin and soft tissue inadequacy, have too stiff a spinal curve, have too much kyphosis, and require repetitive MRI, particularly of the spine. Future data-driven studies using this framework are warranted to generate more specific criteria (e.g. specific degrees of kyphosis) to facilitate clinical decision making for EOS patients.

Level of evidence

Level V—expert opinion.

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Funding

This study was supported in part by grants to the Pediatric Spine Study Group in support of research from Zimmer Biomet, DePuy Synthes Spine, Medtronic, NuVasive, Pediatric Spine Foundation, CSSG0152, OrthoPediatrics, Globus Medical Inc, and Stryker.

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Contributions

HM, RS, BDR, JRB, KFS, JTB, MCW, JBE, JBA, CEJ, BAA, MGV, RFM, Pediatric Spine Study Group: made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. HM, RS, BDR, JRB, KFS, JTB, MCW, JBE, JBA, CEJ, BAA, MGV, RFM, Pediatric Spine Study Group: drafted the work or revised it critically for important intellectual content. HM, RS, BDR, JRB, KFS, JTB, MCW, JBE, JBA, CEJ, BAA, MGV, RFM, Pediatric Spine Study Group: approved the version to be published. HM, RS, BDR, JRB, KFS, JTB, MCW, JBE, JBA, CEJ, BAA, MGV, RFM, Pediatric Spine Study Group: agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Hiroko Matsumoto.

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Conflict of Interest

HM has received consulting fees from the Pediatric Spine Study Group (PSSG), and research grants from Pediatric Orthopaedic Society of North America (POSNA) and Scoliosis Research Society (SRS). RS has no competing interests to disclose. BDR has received research support from Children’s Spine Foundation, SRS, POSNA, Broadwater, Pediatric Orthopaedic Club of New York, OMeGA Medical Grants Association, and Setting Scoliosis Straight Foundation (Harms). JRB has no competing interests to disclose. KFS has no competing interests to disclose. JTB has received consulting fees from Depuy-Synthes and OrthoPediatrics, and honorarium from Oregon Health Sciences University, Dept. of Orthopaedic Surgery. MCW has received grants from Zimmer Biomet, Shriners, POSNA, and consulting fees from Depuy Synthes, Nuvasive Spine, Stryker Spine, and Zimmer Biomet. JBE has received consulting fees from Zimmer/Biomet, and has served on the board for Zimmer/Biomet, Pediatric Spine Foundation, and PSSG. JBA has received consulting fees and honoraria from Depuy Synthes. CEJ has received royalties/licenses from Medtronic. BAA has received royalties/licenses from DePuy Spine, Nuvasive, Stryker Spine, and financial support from NociMed. MGV has received grants and personal fees from Biomet, grants and non-financial support from Children’s Spine Foundation, personal fees from East Coast Orthotics and Prosthetics, financial support from Fox, non-financial support from IPOS, grants from OREF, grants and non-financial support from POSNA, non-financial support from Project for Safety in Spine Surgery, grants from OSRF, grants from SRS, personal fees from Stryker, and non-financial support from Wellinks. RFM has served on the board for POSNA and received consulting fees from Stryker and financial support from Globus Medical.

Ethical approval

This study was approved by the Columbia University Institutional Review Board (Protocol AAAT8087) and was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

This study qualifies for a waiver of consent because it is a survey of surgeons and does not involve patient participation. There is no potential to adversely affect the rights or welfare of subjects since this is a survey to gather surgeon opinion, with no patient data being collected or intervention being tested.

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Matsumoto, H., Sinha, R., Roye, B.D. et al. Contraindications to magnetically controlled growing rods: consensus among experts in treating early onset scoliosis. Spine Deform 10, 1289–1297 (2022). https://doi.org/10.1007/s43390-022-00543-3

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