Sonication in Patients With Spinal Cord Stimulation: A New Approach for Infection Diagnostics.

INTRODUCTION: Spinal cord stimulation (SCS) offers improvement in pain and function for several chronic pain conditions. There are concerns regarding bacterial colonization of the temporary lead extensions and subsequent infection risk in a two-session implantation procedure. Although there is no standardized evaluation of SCS lead contamination, this study evaluates the infection rate and microbial colonization of SCS lead extensions with sonication, a method that is established in implant-related infection diagnostics. MATERIALS AND METHODS: This prospective observational study comprised 32 patients with a two-stage SCS implantation procedure. Microbial colonization of the lead extensions was assessed with sonication. The presence of organisms in the subcutaneous tissue was evaluated separately. Surgical-site infections were recorded. Patient demographics and risk factors including diabetes, tobacco use, obesity, trial length, and infection parameters in serum were recorded and analyzed. RESULTS: The mean age of the patients was 55 years. On average, the trial length was 13 days. In seven cases (21.9%), a microbial lead colonization was found with sonication. In contrast, there was one positive culture (3.1%) from the subcutaneous tissue samples. The C-reactive protein and leukocyte count remained at the preoperative level. One early surgical-site infection (3.1%) occurred. No other late infections occurred six months after surgery. CONCLUSIONS: There is a discrepancy between the presence of microbial colonization and the occurrence of clinically relevant infections. Although the rate of microbial colonization of the lead extensions is high (21.9%), the surgical-site infection rate remained low (3.1%). Therefore, we can conclude that the two-session procedure is a safe approach that is not associated with a higher incidence of infection. Although the sonication method cannot be used as the sole tool for detecting infections in patients with SCS, it can provide additional value in microbial diagnostics in combination with clinical and laboratory parameters and conventional microbiological methods.

First clinical results of a novel minimally-invasive fusion system for the sacroiliac joint.

BACKGROUND: Sacroiliac joint (SIJ) painful dysfunction is a common source of low back pain (LBP). Several surgical treatment options for SIJ fusion were described. A promising treatment option with demonstrated clinical improvement is the minimally-invasive SIJ fusion. OBJECTIVE: The aim of this case study was to document the effectiveness and safety of the new SIJ system (Torpedo®) over a period of 6 months after the minimally invasive implantation. METHODS: Patients with failed conservative treatment of painful SIJ dysfunction were enrolled successively in two centers. The Diagnosis was made by positive response to SIJ-injection with local anesthetic and at least by two positive SIJ provocation tests. The Torpedo® Implant system was used for the implantation. This workpiece made of titanium alloy is characterized by a helical profile geometry (CST: chronical spinal turn) with a hydrophilic surface. The evaluated endpoints LBP and grade of disability were assessed using a 0-10 numerical rating scale (NRS), and Oswestry Disability Index (ODI) preoperatively and at one, three and six months postoperatively. RESULTS: 15 patients (10 female, 5 male; mean age 59 ± 13 years) were operated on one after the other. The pain intensity decreased in all 15 patients. After 6 months, a decrease in the median values of 70% (quartiles 1-3: 65-79%) was calculated. The median values of the Oswestry Disability Index after 6 months were 62% (quartiles 1-3: 53-67) lower than before the operation. Before surgery, 13 patients (87%) were taking opioids for pain management. Six months after the operation, opioids were only needed by 3 patients (20%). Implant malpositioning was not detected on plain radiograph. No surgical site infections or perioperative complications occurred. CONCLUSIONS: The clinical improvement in early follow up and the absence of surgery related complications demonstrate a high grade of device-related safety and effectiveness of the treatment with a novel minimally-invasive SIJ fusion system.

[Minimally invasive arthrodesis of the sacroiliac joint (SIJ)]. / Minimal-invasive Arthrodese des Iliosakralgelenks (ISG).

OBJECTIVE: Pain reduction and improvement in quality of life with sacroiliac joint (SIJ) fusion. INDICATIONS: Chronic SIJ-associated pain; positive response to SIJ injection with local anesthetic; positive SIJ provocation tests; failed conservative therapy over 6 months. CONTRAINDICATIONS: Non-SIJ-associated pain; tumor/infection/unstable fracture in the implantation area; malformations; tumor or osteolysis of the sacrum or ilium bone; active infection at the implantation site; allergy to metal components; secondary gain from illness, request for a pension; inadequately treated osteoporosis. SURGICAL TECHNIQUE: Transarticular placement of Kirschner's wires through the SI joint via minimally invasive lateral approach. Guided preparation of implant site over Kirschner's wires and implantation of 3 triangular, transarticular titanium implants for SIJ fusion. POSTOPERATIVE MANAGEMENT: Deep vein thrombosis prophylaxis. 3 weeks partial weight-bearing and then moving on to full weight-bearing. X­ray controls at defined intervals. Physiotherapy. RESULTS: We enrolled 26 patients who were followed up over the period of 4 years. The evaluated endpoints were low back pain on the visual analog scale (VAS 0-10), grade of disability with the Oswestry Disability Index (ODI) and quality of life with the EuroQOL-5D. At 4 years, mean low back pain improved compared to preoperative (VAS preoperative 8.4, VAS 4 years postoperative 4.6). Mean improvements in ODI (ODI preoperative 58.1, ODI 4 years postoperative 32.1) and EQ-5D (preoperative 0.5, after 4 years 0.7) could be evaluated over the long-term period of 4 years. Satisfaction rates were high and the proportion of subjects taking opioids decreased at the 4­year follow-up (preoperative 82%, postoperative 39%). Implant loosening could not be detected on plain radiograph.

Mid-term outcomes after radiofrequency-targeted vertebral augmentation in the treatment of myeloma associated vertebral fractures.

BACKGROUND: Myeloma patients often suffer from painful vertebral fractures (VCF) which impair their quality of life. Common methods for augmentation of the vertebrae are vertebroplasty, kyphoplasty and radiofrequency-targeted vertebral augmentation (RF-TVA). OBJECTIVE: This study evaluates the long-term effectiveness and safety of RF-TVA in the treatment of myeloma associated VCF. METHODS: Eighty-seven myeloma patients (mean age: 64.7 ± 9.5 years) with VCF were treated with RF-TVA. Patient data were assessed preoperatively and in five postoperative examinations up to 12 months. Pain was measured with the visual analogue scale (VAS) and the impairment was evaluated with the Oswestry-Disability-Index (ODI) at each examination. In addition, the mid vertebral height, kyphosis angle, and additional fractures were evaluated by x-rays. Furthermore, cement leakage was documented. RESULTS: The VAS values were significantly improved in comparison to the preoperative values (p≤ 0.001), but slightly fluctuating during the follow-up period. The ODI was also significantly improved (p≤ 0.001), but it showed a worsening from the 12 months evaluation to the 24 months evaluation. The kyphosis angle and the vertebral height were significantly improved after surgery (p = 0.03, p ≤ 0.001), but worsened steadily to the last follow up examination. Cement leakage was asymptomatic and occurred in 18% of the patients. In 10% of the patients additional fractures were detected in the 24 months evaluation. CONCLUSIONS: The results of our study show that RF-TVA is a safe treatment for myeloma associated vertebral compression fractures, which achieves an acceptable improvement of patient's pain and quality of life.