The clinical and radiographic degenerative spondylolisthesis classification and its predictive value.

INTRODUCTION: The clinical and radiographic degenerative spondylolisthesis (CARDS) classification is a new classification that has been introduced for degenerative spondylolisthesis (DS). It has four categories. Our study aimed to analyse the functional and radiographic outcome following DS surgery based on the preoperative CARDS classification. METHODS: A retrospective study of the prospectively collected Australian Spine Registry database was performed. Data on demographics, patient reported outcome measures including the Oswestry Disability Index (ODI) and EQ-5D-3 L scores, and changes in radiographic measurements were analysed. Based on the preoperative findings all x-rays were classified applying the CARDS classification. RESULTS: Between 2018 and 2021 a total of 54-patients were identified as having had surgery for DS at L4/5. The mean age was 65.3 ± 11.3years and females were predominantly affected (61%). Most cases were of CARDS type C (46%), followed by type B (29%). CARDS type A and D were observed in 18% and 6% respectively. Preoperatively, the L4/5 lordosis was 19.8 ± 6.3° and lumbar lordosis 43.9 ± 12.8°. Postoperatively the L4/5 lordosis alignment changed significantly to 23.5 ± 8.8° (p < 0.05). Preoperatively, the CARDS classification was 34.8 ± 17.4 (type A), 40.5 ± 11.0 (type B), 43.8 ± 12.9 and 50.0 ± 14.4 for type D (Pearson-coefficient 0.284, p = 0.041). Postoperatively this changed to 22.7 ± 16.1, 28.7 ± 21.2, 12.5 ± 13.1, and 6.5 ± 2.1 respectively. Similar improvements were observed for the EQ-5D-3 L. CONCLUSION: This study shows that the CARDS classification correlates with preoperative functional scores as well as helping to predict response to surgery. CARDS will likely assist in operative planning and prognostication. LEVEL OF EVIDENCE: III, therapeutic and prognostic study.

Phase 1 evaluation of an elastomeric nucleus pulposus device as an option to augment disc at microdiscectomy: Experimental results from biomechanical and biocompatibility testing and first in human.

Objective: Whilst microdiscectomy is an excellent reliever of pain for recalcitrant lumbar disc herniation (LDH), it has a high failure rate over time due to the ensuing reduction in mechanical stabilization and support of the spine. One option is to clear the disc and replace it with a nonhygroscopic elastomer. Here, we present the evaluation of biomechanical and biological behavior of a novel elastomeric nucleus device (Kunovus disc device [KDD]), consisting of a silicone jacket and a two-part in situ curing silicone polymer filler. Materials and Methods: ISO 10993 and American Society for Testing and Materials (ASTM) standards were used to evaluate the biocompatibility and mechanics of KDD. Sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, muscle implantation study, direct contact matrix toxicity assay, and cell growth inhibition assay were performed. Fatigue test, static compression creep testing, expulsion testing, swell testing, shock testing, and aged fatigue testing were conducted to characterize the mechanical and wear behavior of the device. Cadaveric studies to develop a surgical manual and evaluate feasibility were conducted. Finally, a first-in-human implantation was conducted to complete the proof of principle. Results: The KDD demonstrated exceptional biocompatibility and biodurability. Mechanical tests showed no Barium-containing particles in fatigue test, no fracture of nucleus in static compression creep testing, no extrusion and swelling, and no material failure in shock and aged fatigue testing. Cadaver training sessions showed that KDD was deemed implantable during microdiscectomy procedures in a minimally invasive manner. Following IRB approval, the first implantation in a human showed no intraoperative vascular and neurological complications and demonstrated feasibility. This successfully completed Phase 1 development of the device. Conclusion: The elastomeric nucleus device may mimic native disc behavior in mechanical tests, offering an effective way for treating LDH by way of Phase 2 and subsequent clinical trials or postmarket surveillance in the future.

Comorbidity data collection across different spine registries: an evidence map.

INTRODUCTION: Comorbidities are significant patient factors that contribute to outcomes after surgery. There is highly variable collection of this information across the literature. To help guide the systematic collection of best practice data, the Australian Spine Registry conducted an evidence map to investigate (i) what comorbidities are collected by spine registries, (ii) how they are collected and (iii) the compliance and completeness in collecting comorbidity data. METHOD: A literature search was performed to identify published studies of adult spine registry data reporting comorbidities. In addition, targeted questionnaires were sent to existing global spine registries to identify the maximum number of relevant results to build the evidence map. RESULTS: Thirty-six full-text studies met the inclusion criteria. There was substantial variation in the reporting of comorbidity data; 55% of studies reported comorbidity collection, but only 25% reported the data collection method and 20% reported use of a comorbidity index. The variation in the literature was confirmed with responses from 50% of the invited registries (7/14). Of seven, three use a recognised comorbidity index and the extent and methods of comorbidity collection varied by registry. CONCLUSION: This evidence map identified variations in the methodology, data points and reporting of comorbidity collection in studies using spine registry data, with no consistent approach. A standardised set of comorbidities and data collection methods would encourage collaboration and data comparisons between patient cohorts and could facilitate improved patient outcomes following spine surgery by allowing data comparisons and predictive modelling of risk factors.

Treating enuresis in children with neurodevelopmental disorders using bell and pad alarm.

OBJECTIVE: There is a high prevalence of enuresis in children with neurodevelopmental disorders, yet research regarding treatment for this group has been neglected. The efficacy of treatment using bell and pad alarm therapy is not well reported especially in children with neurodevelopmental disorders. This study sought to compare the treatment efficacy of practitioner-assisted bell-and-pad enuresis alarm therapy for children with neurodevelopmental disorders and typically developing children. STUDY DESIGN: This study utilized the data of Apos et al. (2018), a retrospective medical record audit collected from multiple clinical settings across Australia. A total of 2986 patient records (3659 treatment records) were included. The participants were children aged 5-16 years, who were diagnosed with enuresis. Children with a neurodevelopmental disorder (n = 158) had a clinical diagnosis present in the medical history of attention deficit disorder, autism spectrum disorder, or intellectual disability. Children who indicated any of the following comorbidities were excluded: cerebral palsy, brain injury, malformation of the renal tract, previous bladder or renal surgery, spinal cord malformation, spinal cord trauma or tumor, or a neurodegenerative disorder. Treatment success was defined as ≥ 14 dry nights. Relapse was defined as one symptom recurrence per month post-interruption of treatment, as defined by the International Children's Continence Society definitions. RESULTS: The success rate for children with neurodevelopmental disorders was 62% and typically developing children was 78%. There was no significant difference between the number of treatments received or relapse rates by those children with a neurodevelopmental disorder and typically developing children. The summary figure shows the percentage of children in each group after their first treatment who were successful (success defined as dry for ≥ 14 days), who succeeded (dry for ≥ 14 days) but then relapsed and those who showed no success. The percentage of children with no NDD who were successfully dry after the first treatment was 78%. Children with ID had success after the first treatment of 59%, the lowest of all groups analyzed. CONCLUSION: The type of alarm therapy reported in this study is effective for treating enuresis in children with neurodevelopmental disorders.

Enuresis Management in Children: Retrospective Clinical Audit of 2861 Cases Treated with Practitioner-Assisted Bell-and-Pad Alarm.

OBJECTIVE: To establish the treatment efficacy of practitioner-assisted bell-and-pad alarm therapy in children with enuresis between the ages of 5 and 16 years by retrospective medical chart review of 2861 children in multiple clinical settings. STUDY DESIGN: This review was conducted across 7 Australian clinical practices. The primary outcome measure was the time taken for children with either primary, secondary, monosymptomatic, or nonmonosymptomatic enuresis to be dry for 14 consecutive nights. The secondary outcome measure was to determine relapse rates, defined as 1 symptom recurrence per month post interruption of treatment. Data were analyzed by correlation and χ2 test via IBM SPSS Statistics (version 22). RESULTS: The overall success rate of the bell and pad treatment was 76%, irrespective of age. The mean treatment time to achieve dryness was 62.1 ± 30.8 days, and the relapse rate was 23%. Concurrent bowel dysfunction was associated with a slightly lower success rate (74%). Concurrent lower urinary tract symptoms were associated with a lower success rate (73%) and greater relapse (1.75 times more likely to relapse). Children with secondary enuresis had significantly greater success than those with primary enuresis (82% vs 74%). CONCLUSION: The type of alarm therapy reported in this study is highly effective. This study will provide the basis for clinical guidelines and practice tools for clinicians, which will help to reduce variation in care pathways for alarm treatment for enuresis.