Degenerate-disc infection study with contaminant control (DISC): a multicenter prospective case-control trial.

BACKGROUND: A bacterial cause of disc degeneration has evoked several controversies and, if true, would lead to a major shift in treatment paradigm. Earlier studies analyzing the relationship of bacterial disc infection within a degenerative cohort featured prolonged cultures susceptible to contamination. The degenerate-disc infection study with contaminant control (DISC) trial aims to investigate this theory further by examining infection rates using a non-degenerative control cohort in comparison to a degenerative internal control cohort and a sham cohort (sampling only sterile paraspinal tissue). To our knowledge, the current study is the largest evaluating the growth of organisms (or possible contamination rate) in paraspinal tissue if prolonged cultures are performed. Protocols on methodology have been previously published. PURPOSE: (1) To investigate the infection rates across cohorts (degenerative vs. nondegenerative control; paraspinal and/or disc controls vs. combined sampling cohorts) using stringent standardized aseptic surgical technique and laboratory processing. (2) To compare our findings to that of the literature and make a statement in support and/or against a possible contamination theory to positive cultures. STUDY DESIGN: Multicenter, multisurgeon case-control trial. PATIENT SAMPLE: In all, 812 surgical samples were retrieved across a 3.5-year period (2013-2016) including 25 trauma controls (nondegenerative), 550 "disc and paraspinal" samples (degenerative cases with internal control), 190 disc-only samples (degenerative cases without internal control), and 46 paraspinal only controls (sham group). OUTCOME MEASURES: Growth and/or Contamination rate (%) per cohort. Chi-square of growth in disc versus paraspinal samples as a means of examining the distribution of false positive and contaminant growth. The impact of previous injections and/or surgery on positive disc or paraspinal growth. Correlation of Modic changes with positive growth rates analyzed with the Kruskal-Wallis Test. The distribution of species in positive samples were also analyzed. METHODS: The DISC trial is registered under Australian and New Zealand clinical trials registry-ACTRN12616000541404. Institutional ethics review was obtained (HREC northern sector 13/218) at the primary center and further centers (n=6) were recruited. Patients undergoing spinal surgery with discectomy were eligible for trial entry with tissue specimens obtained using strict aseptic technique for microbiological examination. All specimens were handled with sterile instruments only and by a fresh instrument to a sterile pot that was closed immediately. Separate pots were used for the disc and paraspinal tissue respectively with similar stringent processing during microbiological assessment. A cohort of the degenerative cases at one single institution also underwent an additional histopathological examination. RESULTS: There was an expected significant difference in gender and age associated with the non-degenerative control group (due to trauma patients) compared with other cohorts. There was a higher percentage of positive-growth in the control group in comparison to the disc and paraspinal and disc only groups across positive disc growth (48% vs. 27% vs. 17%, p<.001). A similar infection rate was observed in the paraspinal samples across the equivalent controls (44% vs. 36% vs. 37%, p=.739). There was a significant difference in the proportions of positive growth with a large proportion of false positives (growth in both disc and paraspinal samples; p<.001). There was no difference in true positive growth between the case and control groups (16.0 vs. 7.7%, p=.112). These trends were preserved across all cohorts and when stratifying by spinal segment (cervical or lumbar). There was no correlation between Modic changes and positive disc culture growth (p=.398, n=144 samples). Cutibacterium (formerly Propionibacterium) acnes was the most dominant pathogen isolated, representing between 50% and 70% of positive disc and paraspinal specimens, followed by staphylococcal species. CONCLUSIONS: Our study failed to find a difference in true infection rates between the nondegenerative and degenerative disc populations. These findings are suggestive of a contamination theory and against a common infective etiology in the setting of discogenic back and neck pain. We believe the rationale for antibiotic therapy in the management of discogenic back pain warrants further evidence to establish efficacy.

A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders.

STUDY DESIGN: A prospective, Phase IV, multicenter, randomized study. OBJECTIVE: The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine. SUMMARY OF BACKGROUND DATA: Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation. METHODS: Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. RESULTS: One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population. CONCLUSION: SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2. LEVEL OF EVIDENCE: 2.

Comparison of Silicate-Substituted Calcium Phosphate (Actifuse) with Recombinant Human Bone Morphogenetic Protein-2 (Infuse) in Posterolateral Instrumented Lumbar Fusion.

Study Design Randomized controlled trial. Objective The aim of this study was to assess the efficacy of the bone grafting substitute silicate-substituted calcium phosphate (SiCaP) compared with recombinant human bone morphogenetic protein 2 (rhBMP-2) and to evaluate the clinical outcomes over a period of 2 years. Methods Patients undergoing PLF surgery for DDD at a single center were recruited and randomized to one of two groups: SiCaP (n = 9) or rhBMP-2 (n = 10). One patient withdrew prior to randomization and another from the rhBMP-2 group after randomization. The radiologic and clinical outcomes were examined and compared. Fusion was assessed at 12 months with computed tomography and plain radiographs. Clinical outcomes were evaluated by recording measures of pain, quality of life, disability, and neurologic status from 6 weeks to 2 years postoperatively. Results In the SiCaP and rhBMP-2 groups, fusion was observed in 9/9 and 8/9 patients, respectively. Pain and disability scores were reduced and quality of life increased in both groups. Leg pain, disability, and satisfaction scores were similar between the groups at each postoperative point; however, back pain was less at 6 weeks and quality of life was higher at 6 months in the SiCaP group than the rhBMP-2 group. Conclusions SiCaP and rhBMP-2 were comparable in terms of achieving successful bone growth and fusion. Both groups achieved similar alleviation of pain and improved quality of life and neurologic, satisfaction, and return to work outcomes following PLF surgery.

Craniocerebral gunshot injuries in children.

INTRODUCTION: Despite the worldwide increase in the incidence of gunshot injuries, there are few large published series on craniocerebral gunshot injuries in children. MATERIALS AND METHODS: The records of 30 consecutive children who were treated for craniocerebral gunshot injuries at the Red Cross War Memorial Children's Hospital from 1989 to 2002 were reviewed retrospectively. The circumstances of the injury, clinical status, CT findings, complications, and outcome were assessed. RESULTS: The median age was 7 years. Seventy-seven percent of the victims were boys. The majority of the children were injured in the crossfire of civilian violence. The initial management consisted of debridement under local anesthesia in 16 children and neurosurgical procedures under general anesthesia were performed in 14. Sixteen children sustained transhemispheric injuries, 5 bihemispheric injuries, 5 tangential injuries, and 4 transventricular injuries. All 3 children with a GCS <4 died within 72 h of admission. Three of the 7 children with GCS 4-7 died but there were no deaths in those children whose GCS was >7 post-resuscitation. Motor deficits, cranial nerve palsies, and visual field defects were very common. Early post-traumatic seizures were the commonest complication (18%). CONCLUSION: Children with higher post-resuscitation GCSs fared better than adults in terms of mortality but not necessarily morbidity. As in the case with adults, the GCS after resuscitation is a very good prognostic indicator of mortality.