The potential of spring distraction to dynamically correct complex spinal deformities in the growing child

Purpose: Current treatment of progressive early onset scoliosis involves growth-friendly instrumentation if conservative treatment fails. These implants guide growth by passive sliding or repeated lengthenings. None of these techniques provide dynamic correction after implantation. We developed the spring distraction system (SDS), by using one or multiple compressed springs positioned around a standard sliding rod, to provide active continuous distraction of the spine to stimulate growth and further correction. The purpose of this study was to determine feasibility and proof of concept of the SDS. Methods: We developed a versatile, dynamic spring distraction system for patients who would benefit from active continuous distraction. This prospective case series evaluates four patients with exceptional and progressive congenital spine deformities. Results: Four patients had a mean age of 6.8 years at surgery with a mean follow-up of 36 months (range 25–45). The mean progressive thoracic lordosis, which was the reason for initiating surgical treatment in two patients, changed from 32° lordosis preoperatively to 1° kyphosis post-operatively. During follow-up, this further improved to 32° thoracic kyphosis. In the two other patients, with cervicothorcacic scoliosis, the main coronal curve improved from 79° pre-operatively to 56° post-operatively and further improved to 42°. The mean T1-S1 spine growth during follow-up for all patients was 1.3 cm/year. There was one reoperation because of skin problems and no device-failures. Conclusion: These early results show the feasibility and the proof of concept of spring-based distraction as a dynamic growth-enhancing system with the potential of further correction of the deformity after implantation

Spring distraction system for dynamic growth guidance of early onset scoliosis: two-year prospective follow-up of 24 patients

BACKGROUND: Current surgical treatment options for early onset scoliosis (EOS), with distraction- or growth-guidance implants, show limited growth and high complication rates during follow-up. We developed a novel implant concept, which uses compressed helical springs positioned around the rods of a growth-guidance construct. This spring distraction system (SDS) provides continuous corrective force to stimulate spinal growth, can be easily contoured, and can be used with all standard spinal instrumentation systems. PURPOSE: To assess curve correction and -maintenance, spinal growth, complication rate, and health-related quality of life following SDS treatment. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: All skeletally immature EOS patients with an indication for growth-friendly surgery and without bone- or soft tissue weakness were eligible to receive SDS. For this study, all included patients with at least 2-year follow-up were analyzed. OUTCOME MEASURES: Coronal Cobb angle, sagittal parameters, T1-T12, T1-S1, and instrumented (ie, bridged segment) spinal height and freehand length, complications and re-operations, and the 24-Item Early Onset Scoliosis Questionnaires (EOSQ-24) score. METHODS: All primary- and conversion patients (conversion from failed other systems) with SDS and ≥2 years follow-up were included. Radiographic parameters were compared preoperatively, postoperatively and at latest follow-up. Spinal length increase was expressed as mm/year. RESULTS: Twenty-four skeletally immature EOS patients (18 primary and 6 conversion cases) were included. There were five idiopathic, seven congenital, three syndromic, and nine neuromuscular EOS patients. Mean age at implantation was 9.1 years (primary: 8.4; conversion: 11.2). Major curve improved from 60.3° to 35.3°, and was maintained at 40.6° at latest follow-up. Mean spring length increase during follow-up was 10.4 mm/year. T1-S1 height increased 9.9mm/year and the instrumented segment height showed a mean increase of 0.7 mm/segment/year. EOSQ-24 scores dropped after surgery from 75.6 to 67.4 but recovered to 75.0 at latest follow-up. In total, 17 reoperations were performed. Ten reoperations were performed to treat 9 implant-related complications. In addition, 7 patients showed spinal growth that exceeded expected growth velocity; their springs were retensioned during a small reoperation. CONCLUSION: The 2-year follow-up results from this prospective cohort study indicate that the concept of spring distraction may be feasible as an alternative to current growing spine solutions. Curve correction and growth could be maintained satisfactory without the need for repetitive lengthening procedures. However, as in all growth-friendly implants, complications and reoperations could not be prevented, which emphasizes the need for further improvement

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

Spinal Growth in Patients With Juvenile Idiopathic Scoliosis Treated With Boston Brace: A Retrospective Study

STUDY DESIGN: Retrospective comparative cohort. OBJECTIVE: The aim of this study was to determine whether spinal growth is restricted by brace treatment in patients with juvenile idiopathic scoliosis (JIS). SUMMARY OF BACKGROUND DATA: Spinal fusion can negatively affect spinal growth if performed before the growth spurt. Brace treatment is often given in this young population to control the spinal deformity while allowing spinal growth. It is unknown whether the applied pressure of brace treatment on spine results in growth restriction. The aim of the study is to evaluate spinal growth in braced JIS patients. METHODS: A total of 49 JIS patients treated with Boston brace were retrospectively selected from a scoliosis database. T1-T12/T1-S1 perpendicular and freehand (height following the curvature of the spine) height were measured on radiographs of patients that had reached skeletal maturity and were matched with 49 controls without scoliosis. Spinal growth was calculated from brace initiation until cessation and was compared with normal spinal growth values as reported by Dimeglio. RESULTS: The mean age of diagnosis was 7.4 years. The age of the braced scoliosis patients at skeletal maturity was 17.5 years. The average T1-T12 and T1-S1 freehand height measured by following the curvature of the scoliosis was 29.3 cm (±2.4) and 47.2cm (±4.0), respectively, and was not significant different from the control group. Brace treatment was initiated at a mean age of 11.2 and the mean age of cessation was 14.8. Spinal growth (freehand) during brace treatment was 1.10 cm/year for the thoracic spine and 1.78 cm/year for the full spine and was not significant different from normal values. CONCLUSION: No significant influence of bracing on spinal growth could be detected in this cohort of JIS patients. The spinal height measurements at skeletal maturity were similar to matched controls. In addition, spinal growth did not significantly differ from Dimeglio normal growth data, indicating that the effect of bracing on spinal growth is absent or minimal. LEVEL OF EVIDENCE: 3

Intrawound Treatment for Prevention of Surgical Site Infections in Instrumented Spinal Surgery : A Systematic Comparative Effectiveness Review and Meta-Analysis

Study Design: Systematic review and meta-analysis. Objectives: To determine the efficacy of intrawound treatments in reducing deep surgical site infections (SSIs) in instrumented spinal surgery. Methods: The electronic databases MEDLINE, EMBASE, and Cochrane were systematically searched for intrawound treatments for the prevention of SSIs in clean instrumented spine surgery. Both randomized controlled trials and comparative cohort studies were included. The results of included studies were pooled for meta-analysis. Results: After full text- and reference screening, 20 articles were included. There were 2 randomized controlled trials and 18 observational studies. Sixteen studies investigated the use of intrawound antibiotics, and 4 studies investigated the use of intrawound antiseptics. The relative risk of deep SSI for any treatment was 0.26 (95% confidence interval [CI] 0.16-0.44, P < .0001), a significant reduction compared with controls receiving no treatment. For patients treated with local antibiotics the relative risk was 0.29 (95% CI 0.17-0.51, P < .0001), and patients treated with local antiseptics had a relative risk of 0.14 (95% CI 0.05-0.44, P = .0006). Conclusions: Both the use of antibiotic and antiseptic intrawound prophylactics was associated with a significant 3 to 7 times reduction of deep SSIs in instrumented spine surgery. No adverse events were reported in the included studies