One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients

Abstract

Purpose

Progressive early-onset scoliosis raises major challenges for surgeons, as growth must be preserved. With traditional growing rods, the need for repeated surgery is associated with numerous complications, high costs, and heavy psychosocial burden on the patient and family. We assessed the safety and efficacy of a new one-way self-expanding rod (OWSER).

Methods

This prospective single-centre phase 2 study included two groups of children with progressive EOS treated by the OWSER in 2016–2017: Ten received a unilateral construct to treat progressive non-neuromuscular curves and 10 others a bilateral construct for neuromuscular scoliosis. Clinical and radiological data were assessed at surgery and 3, 6, 12, 18 months later. The primary endpoint was success defined as the absence of repeated surgery at 12 months.

Results

In the non-neuromuscular group, rod expansion occurred in 5 of 10 patients [95% CI 19–81]; in the five other patients, rotational conflict inside the domino prevented rod expansion, four of them required surgery within the first 12 months. Rod expansion occurred spontaneously and during monthly traction sessions in all 10 neuromuscular patients [95% CI 69–100], without mechanical or device-related complications. Residual pelvic obliquity was improved by −3° [− 6.0 to 9.5] at 18 months. Lung function improved in the non-neuromuscular group.

Conclusion

In neuromuscular diseases, the OWSER bilateral construct seems to be safe and less aggressive. Used as unilateral construct in non-neuromuscular group, it was less effective. Accordingly, we recommend the bilateral construct for all aetiologies. That device could avoid further surgery and reduce the rate of complications after long follow-up.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

References

  1. 1.

    Skaggs DL, Akbarnia BA, Flynn JM et al (2014) A Classification of growth friendly spine implant. J Pediatr Orthop 34(3):260–274

    Article  Google Scholar 

  2. 2.

    Thompson GH, Akbarnia BA, Campbell RM Jr (2007) Growing rod techniques in early-onset scoliosis. J Pediatr Orthop 27:354–361

    Article  Google Scholar 

  3. 3.

    Pratt RK, Webb JK, Burwell RG, Cummings SL (1999) Luque trolley and convex epiphysiodesis in the management of infantile and juvenile idiopathic scoliosis. Spine 24(15):1538–1547

    CAS  Article  Google Scholar 

  4. 4.

    Ouellet J (2011) Surgical technique: modern Luque trolley, a self-growing rod technique. Clin Orthop Relat Res 469(5):1356–1367

    Article  Google Scholar 

  5. 5.

    McCarthy RE, Luhmann S, Lenke L, McCullough FL (2014) The shilla growth guidance technique for early-onset spinal deformities at 2-year follow-up: a preliminary report. J Pediatr Orthop 34(1):1–7

    Article  Google Scholar 

  6. 6.

    Andras LM, Joiner ERA, McCarthy RE, McCullough L, Luhmann SJ, Sponseller PD, Emans JB, Barrett KK, Skaggs DL, GSSG. (2015) Growing rods versus shilla growth guidance: better cobb angle correction and T1–S1 length increase but more surgeries. Spine Deform 3:246–252

    Article  Google Scholar 

  7. 7.

    Cheung KM-C, Cheung JP-Y, Samartzis D et al (2012) Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet 379:1967–1974

    Article  Google Scholar 

  8. 8.

    Teoh KH, Winson DMG, James SH et al (2016) Magnetic controlled growing rods for early-onset scoliosis: a 4-year follow-up. Spine J 16:S34–S39

    Article  Google Scholar 

  9. 9.

    Thompson W, Thakar C, Rolton DJ et al (2016) The use of magnetically controlled growing rods to treat children with early-onset scoliosis: early radiological results in 19 children. Bone Jt J 98B:1240–1247

    Article  Google Scholar 

  10. 10.

    Lebon J, Batailler C, Wargny M et al (2017) Magnetically controlled growing rod in early onset scoliosis: a 30-case multicenter study. Eur Spine J 26:1567–1576

    Article  Google Scholar 

  11. 11.

    Teoh KH, Winson DMG, James SH et al (2016) Do magnetic growing rods have lower complication rates compared with conventional growing rods? Spine J 16:S40–S44

    Article  Google Scholar 

  12. 12.

    Teoh KH, von Ruhland C, Evans SL et al (2016) Metallosis following implantation of magnetically controlled growing rods in the treatment of scoliosis: a case series. Bone Jt J 98(12):1662–1667

    Article  Google Scholar 

  13. 13.

    Choi E, Yazsay B, Mundis G et al (2017) Implant complications after magnetically controlled growing rods for early onset scoliosis: a multicenter retrospective review. J Pediatr Orthop 37:e588–e592

    Article  Google Scholar 

  14. 14.

    Kwan KYH, Alanay A, Yazici M et al (2017) Unplanned reoperations in magnetically controlled growing rod surgery for early onset scoliosis with a minimum of two-year follow-up. Spine 42:E1410-4

    Article  Google Scholar 

  15. 15.

    Cheung JPY, Yiu KKL, Samartzis D et al (2017) Rod lengthening with the magnetically controlled growing rod: factors influencing rod slippage and reduced gains during distractions. Spine 43(7):E399–E405

    Article  Google Scholar 

  16. 16.

    Thakar C, Kieser DC, Mardare M et al (2018) Systematic review of the complications associated with magnetically controlled growing rods for the treatment of early onset scoliosis. Eur Spine J 27:2061–2071

    Article  Google Scholar 

  17. 17.

    Subramanian T, Ahmad A, Mardare DM et al (2018) A six-year observational study of 31 children with early-onset scoliosis treated using magnetically controlled growing rods with a minimum follow-up of two years. Bone Jt J 100(9):1187–1200

    Article  Google Scholar 

  18. 18.

    Miladi L, Journe A, Mousny M (2013) H3S2 (3 hooks, 2 screws) construct: a simple growing rod technique for early onset scoliosis. Eur Spine J 22(2):S96-105

    Article  Google Scholar 

  19. 19.

    Miladi L, Gaume M, Khouri N et al (2018) Minimally invasive surgery for neuromuscular scoliosis: results and complications in a series of one hundred patients. Spine 43(16):E968–E975

    Article  Google Scholar 

  20. 20.

    Akbarnia BA, Breakwell LM, Marks DS et al (2008) Dual growing rod technique followed for three to eleven years until final fusion: the effect of frequency of lengthening. Spine 33:984–90

    Article  Google Scholar 

  21. 21.

    Bess S, Akbarnia BA, Thompson GH et al (2010) Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Jt Surg Am 92:2533–2543

    Article  Google Scholar 

  22. 22.

    Watanabe K, Uno K, Suzuki T et al (2013) Risk factors for complications associated with growing-rod surgery for early-onset scoliosis. Spine 38:E464-8

    Article  Google Scholar 

  23. 23.

    Sankar WN, Skaggs DL, Yazici M et al (2011) Lengthening of dual growing rods and the law of diminishing returns. Spine 36:806–9

    Article  Google Scholar 

  24. 24.

    Cahill PJ, Marvil S, Cuddihy L et al (2010) Autofusion in the immature spine treated with growing rods. Spine 35:E1199-203

    Article  Google Scholar 

Download references

Acknowledgements

We thank the Assistance Publique Hôpitaux de Paris who sponsored the study protocol.

We thank Euros Company the manufacturer who donated the OWSER devices and contributed financially to the study. We thank Christophe Glorion and Vicken Topouchian for their participation in surgical procedures. We are grateful to the Clinical Research Unit team of Necker-Cochin Hospitals Group, especially Elodie Henry, Laure Choupeaux, and Loreto Naya Aquilue. We are also indebted to the rehabilitation team of Necker Hospital, for their help with managing the patients. We thank the patients and their families for their agreement and collaboration. We also thank Antoinette Wolfe for its help for manuscript redaction.

Funding

Euros Company (La Ciotat, France), the company that manufactures the device used in this clinical trial, funded the study. Euros Company had no role in designing the study, collecting the data, analysing or interpreting the findings, writing the study report, or deciding to submit the study report for publication. No authors of this paper received any financial or nonfinancial benefits in relation with this study.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Lotfi Miladi.

Ethics declarations

Conflict of interest

Lotfi MILADI has intellectual property rights with Euros Company. All other authors declare that they have no conflict of interest.

IRB approval

The Regional Ethics Committee (N° 2014-06-10) and National Drug Safety Agency (ANSM, DMTCOS/DMTCHIR/LAB/2014-A01043-44-A) approved the study. All parents or guardians provided written informed consent. The study was registred on ClinicalTrials.gov (NCT02266667).

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Miladi, L., Khouri, N., Pradon, J. et al. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J (2021). https://doi.org/10.1007/s00586-021-06732-4

Download citation

Keywords

  • Growing rods
  • One-way self-expanding rod
  • Neuromuscular scoliosis
  • Early-onset scoliosis
  • Bipolar technique