Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Risks, consequences, and prevention of falls of older people in oral healthcare centers.

One-third of community-dwelling people older than 65 years of age fall each year, and half of them fall at least twice a year. Older care home residents are approximately three times more likely to fall when compared to community-dwelling older people. Risk indicators for falls are related to the older people's body, environment, behavior, and activities. An important health risk indicator is (orthostatic or postprandial) hypotension, which may induce cerebral hypoperfusion. Although the majority of falls remain without major consequences, 10% to 25% of falls in care homes result in bodily trauma. Prevalent fall-related injuries are brain injury, lower extremity fracture including hip fracture and forearm/wrist fracture, facial fracture, humeral fracture, and rib/scapular fracture. As fall accidents by older people can have severe consequences, prevention of falls is of paramount importance. Healthcare providers, including oral healthcare providers, should inform older people on risks of falling and draw attention to potentially hazardous arrangements.

Complications After Percutaneous Pedicle Screw Fixation for the Treatment of Unstable Spinal Metastases.

BACKGROUND: Complications after surgical stabilization for the treatment of unstable spinal metastases are common. Less invasive surgical (LIS) procedures are potentially associated with a lower risk of complications; however, little is known regarding the complications after LIS procedures for the treatment of spinal metastases. Our primary objective was to determine the characteristics and rate of complications after percutaneous pedicle screw fixation (PPSF) for the treatment of mechanically unstable spinal metastases. The secondary objective was to identify factors associated with the occurrence of complications and survival. METHODS: A retrospective multicenter cohort study of patients who underwent PPSF between 2009 and 2014 for the treatment of unstable spinal metastases was performed. Patient data pertaining to demographics, diagnosis, treatment, neurologic function, complications, and survival were collected. RESULTS: A total of 101 patients were identified, 45 men (45 %) and 56 women (55 %) with a mean age of 60.3 ± 11.2 years. The median operating time was 122 (range 57-325) minutes with a median blood loss of 100 ml (based on 41 subjects). Eighty-eight patients (87 %) ambulated within the first 3 days after surgery. An overall median survival of 11.0 (range 0-70) months was observed, with 79 % of the patients alive at 3 months after treatment. Eighteen patients experienced a total of 30 complications; nonsurgical complications were the most commonly encountered. Prolonged operating time was independently associated with an increased risk of complications. CONCLUSIONS: A complication rate of 18 % was found after PPSF for unstable spinal metastases. Potential advantages of less invasive treatment are limited blood loss and high early ambulation rate.

Sudden proximal spinal dislocation with complete spinal cord injury 1 week after spinal fusion in a child with Prader-Willi syndrome: a case report.

STUDY DESIGN: Case report. OBJECTIVE: To describe a sudden spinal cord injury in a girl with Prader-Willi syndrome (PWS) 1 week after posterior T2-L3 fusion. SUMMARY OF BACKGROUND DATA: PWS is a genetic disorder characterized by several features including growth deficiency, hypotonia, obesity, and spinal deformities. In PWS patients the prevalence of scoliosis and of kyphosis is reported to be 15% to 86% and 8% to 40%, respectively. Operative treatment carries specific and serious risks in these patients. METHODS: A 13-year-old girl with PWS underwent a ventral release and a posterior spinal fusion for a scoliosis with hyperkyphosis of the thoracic spine. Preoperatively, she had no osteopenia or obesity. Posterior instrumentation consisted of fixation with pedicle screws, proximally assisted by a bilateral transverse hook to prevent junctional hyperkyphosis. RESULTS: Postoperative recovery was initially uneventful; however, 1 week after operation the patient suddenly suffered a complete spinal cord lesion at level T4. This was due to myelum compression with a spinal dislocation cranial to the fusion level, and subsequent proximal hook failure. The patient underwent immediate removal of the transverse hooks, an extension of the fusion to T1, and a laminectomy at T2. Eighteen months after the event she was still paraplegic. CONCLUSION: This report describes a sudden and complete spinal cord lesion 1 week after spinal fusion in a child with PWS. Although such an event is often attributed to osteopenia, this was not proven in this case. To our knowledge, this is the first report to describe this event developing so soon and so suddenly after primary surgery. This case report confirms that spinal surgery in patients with PWS carries an increased risk of junctional hyperkyphosis and pullout of hardware.