Three-dimensional correction of scoliosis by a double spring reduction system as a dynamic internal brace: a pre-clinical study in Göttingen minipigs.

BACKGROUND CONTEXT: Adolescent idiopathic scoliosis (AIS) is a major skeletal deformity that is characterized by a combination of apical rotation, lateral bending and apical lordosis. To provide full 3D correction, all these deformations should be addressed. We developed the Double Spring Reduction (DSR) system, a (growth-friendly) concept that continuously corrects the deformity through two different elements: A posterior convex Torsional Spring Implant (TSI) that provides a derotational torque at the apex, and a concave Spring Distraction System (SDS), which provides posterior, concave distraction to restore thoracic kyphosis. PURPOSE: To determine whether the DSR components are able to correct an induced idiopathic-like scoliosis and to compare correction realized by the TSI alone to correction enforced by the complete DSR implant. STUDY DESIGN/SETTING: Preclinical randomized animal cohort study. PATIENT SAMPLE: Twelve growing Göttingen minipigs. OUTCOME MEASURES: Coronal Cobb angle, T10-L3 lordosis/kyphosis, apical axial rotation, relative anterior lengthening. METHODS: All mini-pigs received the TSI with a contralateral tether to induce an idiopathic-like scoliosis with apical rotation (mean Cobb: 20.4°; mean axial apical rotation: 13.1°, mean lordosis: 4.9°). After induction, the animals were divided into two groups: One group (N=6) was corrected by TSI only (TSI only-group), another group (N=6) was corrected by a combination of TSI and SDS (DSR-group). 3D spinal morphology on CT was compared between groups over time. After 2 months of correction, animals were euthanized. RESULTS: Both intervention groups showed excellent apical derotation (TSI only-group: 15.0° to 5.4°; DSR-group: 11.2° to 3.5°). The TSI only-group showed coronal Cobb improvement from 22.5° to 6.0°, while the DSR-group overcorrected the 18.3° Cobb to -9.2°. Lordosis was converted to kyphosis in both groups (TSI only-group: -4.6° to 4.3°; DSR-group: -5.2° to 25.0°) which was significantly larger in the DSR-group (p<.001). CONCLUSIONS: The TSI alone realized strong apical derotation and moderate correction in the coronal and sagittal plane. The addition of distraction on the posterior concavity resulted in more coronal correction and reversal of induced lordosis into physiological kyphosis. CLINICAL SIGNIFICANCE: This study shows that dynamic spring forces could be a viable method to guide the spine towards healthy alignment, without fusing it or inhibiting its growth.

Induction of a representative idiopathic-like scoliosis in a porcine model using a multidirectional dynamic spring-based system.

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.