Surgical Treatment of Patients with Sacroiliac Joint Syndrome: Comparative Study of Two Implants. / Operative Behandlung von Patienten mit Iliosakralgelenksyndrom: Vergleichsstudie zweier Implantate.

The treatment of patients with ISJ dysfunction is difficult due to the multifactorial causes of pain and various problems in clarification. Treatment includes physical therapy, corticosteroids, prolotherapy, radiofrequency denervation and sacroiliac joint fusion. A new option for the surgical treatment of ISG dysfunction is the Torpedo implant system. For a safe fusion, only 2 implants are needed, which are available in lengths of 30-50 mm. The new implant system has been tested in pilot studies for efficacy and biocompatibility with good results. For further documentation for the Torpedo implant system, a comparative study against the iFuse system was carried out.Two different implants were used: Group 1: Deltacor Torpedo, Group 2: iFuse implants (Si-Bone). The data generated during admission and subsequent check-ups (VAS, ODI, opioid use) were entered into an evaluation file set up for this purpose. Follow-up appointments were set at 1 month, 3, 6 and 12 months postoperatively.The data of 65 patients were evaluated comparatively. In all comparisons, only very small effect sizes were found with regard to the differences in the decrease in pain intensities, so that equivalent effectiveness of the two methods could initially be postulated from a clinical point of view. Most patients in both groups reported taking opioids to treat pain before surgery. According to the decrease in pain intensity, opioid treatment could be discontinued in some patients after the operation. After 12 months, the number of patients treated with opioids decreases to 23% in group 1 and to 17% in group 2. The success of the fusions with the two methods can also be proven by image documentation, from which the position of the implants can also be clearly recognised. In no case was there any loosening.Overall, the evaluation of this study allows the conclusion that both implant systems can be successfully used for the treatment of patients with ISJ syndrome. The present results should be confirmed in further comparative studies with the proposed evaluation methods.

Low vitamin D levels affect outcomes of orthopedic spinal surgery: An observational study in clinical practice.

BACKGROUND: Low vitamin D is a major risk factor for osteoporotic fractures. Evidence also suggests correlation between deficiency and musculoskeletal pain. OBJECTIVE: Non-interventional study in patients undergoing spine surgery to investigate links between vitamin D levels and clinical features. METHODS: 25-OH vitamin D levels were assessed in two cohorts: Cohort 1 (vertebral fractures; VF) and Cohort 2 (other spinal issues; excluding VF). Lab values as well as painDETECT questionnaires, VAS and Oswestry Disability Index (ODI) were recorded. Follow-up visits were conducted a few days and 6 weeks postoperatively. RESULTS: One hundred and nine patients were enrolled. Mean VAS measured 72 mm in Cohort 1 and 55 mm in Cohort 2. Mean vitamin D concentrations were 16.8 ± 11 ng/ml in Cohort 1 and 18.3 ± 11 ng/ml in Cohort 2. VAS and ODI significantly correlated with vitamin D levels. Median painDETECT scores were 9 in Cohort 1 and 16 in Cohort 2. Six weeks postoperatively mean VAS was 31.4 ± 28 mm in Cohort 1 and 23.3 ± 21 mm in Cohort 2. Median painDETECT scores were 5 in both cohorts. CONCLUSION: Interactions are apparent between neuropathic pain and vitamin D serum levels. Consequently, vitamin D should be monitored in all patients requiring spinal surgery.

A novel PLIF PEEK interbody cage with an impactionless insertion technology: A case series with a mid-term follow up of three years.

BACKGROUND: Spinal fusion surgery has become one of the most common spinal procedures during the recent years. Searching for an optimum structural stability of the vertebral interspace, surgical implants which can be inserted via a posterior lumbar interbody fusion (PLIF) approach have been enhanced recently. OBJECTIVE: Evaluation of safety and efficacy of a novel PLIF polyetheretherketone (PEEK) interbody cage (TWIST) with an impactionless insertion technique. METHODS: Surgical outcome in 15 patients treated with the new system were observed preoperatively, one and three years after surgery using the Oswestry Disability Index (ODI), a Visual Analogue Scale (VAS) for pain and radiological outcome analysis of fusion success. RESULTS: Fifteen patients (7 female, 8 male) were included in the test series. After three years ODI and VAS were significantly improved. The pain intensity was reduced by more than 75% after one year and after 3 years, pain intensity was about 60% below the initial situation. The Oswestry values (ODI) improved significantly in all patients after 3 years. The fusion evaluation showed a fusion success in 87% of the patients. CONCLUSION: The clinical and radiological results of this first series give a positive standing and important information on the efficacy and safety over 3 years. The follow-up checks with imaging techniques showed that the fusions were very successful and functional outcome as well as pain reduction were increased.

[Diagnosis of Patients with Painful Sacroiliac Joint Syndrome]. / Moderne Diagnostik und minimalinvasive Operationsmethoden bei Patienten mit schmerzhaftem Iliosakralgelenksyndrom.

Pain coming from the sacroiliac (SI) joints can explain up to 25% of all chronic low back pain. A careful differential diagnosis is required to avoid misdiagnosis of low back pain. In addition to historical findings, positive findings on physical examination maneuvers that stress the SI joint are a key component diagnosis. The SI joint is confirmed as a pain generator when intraarticular injection of local anaesthetics provides acute back pain relief. Minimally invasive SI joint fusion is clearly superior to invasive open surgical procedures, with decreased blood loss and tissue disruption, shorter procedure times and shorter hospital stays. Especially well documented are the results of minimally invasive SI joint fusion using iFuse Implant System®. The device's triangular profile, combined with a titanium plasma spray coating, ensures both an immediate and long-lasting joint stabilization.

The Vertect Jack Device: A new method for augmentation of vertebral fractures. Clinical study with comparisons to kyphoplasty.

BACKGROUND: Kyphoplasty is a proven minimally invasive procedure for the treatment of patients with osteoporotic fractures. By augmentation of fractured vertebral body, however, a very large portion of the intervertebral structures will be destroyed. With the help of a new device (Vertect Jack Device), the erection of the vertebral body will be carried out more gentle. OBJECTIVE: In the present study, the new method should be clinically tested for efficacy and safety for the first time. As a comparison results of previous treatments with kyphoplasty were used. METHODS: For Vertect Jack Device study patients with painful vertebral fractures were selected in which conservative treatment had not yielded sufficient results. For comparison random data from the records of patients who had been treated with kyphoplasty were selected. The Vertect Jack Device was placed under the central fractures and then erected. After having restorted the vertebral height the device was removed and cement injected. Clinical and radiological examinations were carried out before and after 1,3, and 6 months. RESULTS: In the Vertect Jack Device Group the data of 40 patients were evaluated. For group 2 (kyphoplasty) 50 patients were selected. There was a significant difference in the duration of the surgery (Group 1: 27.4, Group 2: 45.9 minutes). A significant difference of 20 mm with regard to the reduction of VAS scores (0-100 mm pain intensity) was detected. Under the application of the Vertect Jack Device an average increase of 3.1 mm of vertebral height was achieved. In group 2, the erection averaged 0.4 mm. A correlation between the postoperative change of vertebral body height and VAS scores could not be detected in both groups. CONCLUSIONS: The comparative analysis of this study shows that promising results can be achieved with the augmentation of vertebral fractures with the Vertect Jack Device. When compared with kyphoplasty, advantages show in terms of targeted and thus more gentle application possibility and better pain relief over a period of 6 months after surgery. Further study results should help to demonstrate the efficacy and tolerability of the new method.

Treatment of Hypertensive Patients with a Fixed-Dose Combination of Bisoprolol and Amlodipine: Results of a Cohort study with More Than 10,000 Patients.

INTRODUCTION: Many patients need more than one antihypertensive agent for effective blood pressure (BP) control. Prescription of a fixed-dose combination (FDC) of bisoprolol and amlodipine in one tablet has been shown to significantly improve patient adherence. This non-interventional study investigated the effects on adherence and BP control of switching from a free-dose combination of the two antihypertensive substances to a FDC in a larger patient population. METHODS: Patients aged ≥18 years with essential hypertension were switched at least 4 weeks prior to study initiation from a free-dose combination of bisoprolol and amlodipine to the FDC. Dosage adjustment was implemented only if medically indicated. Adherence was assessed on the basis of the ratio of pills used to pills dispensed (%) at each visit (pill count). BP and key laboratory values were determined at baseline, 3 and 6 months. RESULTS: 10,532 patients (average age 59 years; 48% female) were recruited between 2013 and 2014; 22% of patients had type 2 diabetes and 38% had cardiovascular disease. The mean doses of the freely combined drugs prior to switching were 5.5 mg bisoprolol and 6.1 mg amlodipine once daily. The mean daily doses prescribed in the FDC were 5.8 and 6.4 mg, respectively. Pill counts at 6 months revealed a good to excellent adherence in >95% of the patients. Comparison of BP at baseline and at 6 months showed substantial changes (mean systolic BP: 147.3 vs. 130.9 mmHg; mean diastolic BP: 87.9 vs. 79.1 mmHg). Clinically relevant improvement in systolic BP was established for 82% of patients. In patients with comorbidities, switching to FDC produced a substantial improvement in BP. A total of 89 (0.7%) adverse events (AEs) were reported, including edema, headache, dizziness, bradycardia, nausea, and skin reactions. Only three AEs were classified as serious. CONCLUSION: These data from a non-interventional study in a large patient population demonstrate the benefits of prescribing a FDC of bisoprolol-amlodipine in terms of an excellent adherence and an associated improvement in control of previously elevated BP, which may be relevant in real-life practice. FUNDING: Merck KGaA.