Background Context: Scoliosis is a 3D deformity of the spine in which vertebral rotation plays an important role. However, no treatment strategy currently exists that primarily applies a continuous rotational moment over a long period of time to the spine, while preserving its mobility. We developed a dynamic, torsional device that can be inserted with standard posterior instrumentation. The feasibility of this implant to rotate the spine and preserve motion was tested in growing mini-pigs.

Purpose: To test the quality and feasibility of the torsional device to induce the typical axial rotation of scoliosis while maintaining growth and mobility of the spine.

Study Design: Preclinical animal study with 14 male, 7 month old Gottingen mini-pigs. Comparison of two scoliosis induction methods, with and without the torsional device, with respect to 3D deformity and maintenance of the scoliosis after removal of the implants.

Methods: Fourteen mini-pigs received either a unilateral tether-only (n=6) or a tether combined with a contralateral torsional device (n=8). X-rays and CT-scans were made post-operative, at 8 weeks and at 12 weeks. Flexibility of the spine was assessed at 12 weeks. In 3 mini-pigs per condition, the implants were removed and the animals were followed until no further correction was expected.

Results: At 12 weeks the tether-only group yielded a coronal Cobb angle of 16.8±3.3°For the tether combined with the torsional device this was 22.0±4.0°. The most prominent difference at 12 weeks was the axial rotation with 3.6±2.8° for the tether-only group compared to 18.1±4.6° for the tether-torsion group. Spinal growth and flexibility remained normal and comparable for both groups. After removal of the devices, the induced scoliosis reduced by 41% in both groups. There were no adverse tissue reactions, implant complications or infections.

Conclusion: The present study indicates the ability of the torsional device combined with a tether to induce a flexible idiopathic-like scoliosis in mini-pigs. The torsional device was necessary to induce the typical axial rotation found in human scoliosis.

Clinical Significance: The investigated torsional device could induce apical rotation in a flexible and growing spine. Whether this may be used to reduce a scoliotic deformity remains to be investigated.

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Source
http://dx.doi.org/10.1016/j.spinee.2021.03.015DOI Listing

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