24-Month Open-Label Teriparatide Once-Weekly Efficacy Research Trial Examining Bone Mineral Density in Subjects with Primary Osteoporosis and High Fracture Risk

Introduction

To clarify the additional efficacy and safety benefits of 24 months’ treatment with the once-weekly formulation of teriparatide, which is currently used for 72 weeks.

Methods

This was a multicenter, open-label, single-arm study conducted in Japan. Subjects who were 65 years or older with prevalent vertebral fractures received once-weekly subcutaneous injection of 56.5 μg teriparatide for 24 months. The main outcome measure was percentage change from baseline in lumbar (L2–L4) BMD measured by dual-energy X-ray absorptiometry.

Results

A total of 189 subjects received at least one dose of the once-weekly formulation of teriparatide. Lumbar, femoral neck, and total hip BMD increased significantly compared with baseline at Weeks 24, 48, 72, and 104. In addition, significant increases in lumbar (+1.5%) and femoral neck (+0.8%) BMD were noted at Week 104 compared with Week 72. Significant increases from baseline in BMD for radius 1/10 were noted at Weeks 24 and 104. No substantial increases were noted in the cumulative incidences of new vertebral fracture and other types of fracture after Week 72. The safety profile seen in the first 72 weeks remained unchanged until 104 weeks.

Conclusion

The once-weekly formulation of teriparatide is effective and safe for the treatment of osteoporosis over 24 months. The limitation of this study is that this was an open-label, single-arm study. Funding: Asahi Kasei Pharma Corporation. Clinical Trial Registration: JapicCTI-132276.

     

Current Concepts in Talar Neck Fracture Management

Purpose of the review

Talar neck fractures are a rare but potentially devastating injury, which require a comprehensive understanding of the unique osteology, vasculature, and surrounding anatomy to recognize pathology and treat correctly. The purpose of this article is to describe both classic and current literature to better understand the evolution of talar neck fracture management.

Recent findings

Urgent reduction of displaced fractures and dislocations remains the standard of care to protect the soft tissue envelope and neurovascular structures. Delayed definitive fixation has proven to be safe. CT is the imaging modality of choice to fully identify the fracture pattern and associated injuries. Anatomic reduction and restoration of the peritalar articular surfaces are the pillars of talar neck fracture treatment. Dual incision approach with plate and screw fixation has become the modern surgical strategy of choice to accomplish these goals. Although complications such as osteonecrosis (ON) and posttraumatic arthritis (PTA) can still occur at high rates, treatment should be dictated by patient symptoms.

Summary

Talar neck fractures pose treatment challenges with both initial injury and potential sequelae. Future research will determine whether modern treatment algorithms will decrease complication rate and improve patient outcome.

     

Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia

Introduction

Osteoporosis is characterized by low bone mineral density (BMD) and an increased risk of fracture. In randomized controlled trials, denosumab has been shown to significantly reduce the fracture risk in women with osteoporosis. However, little is known about the real-world management of women who are prescribed denosumab.

Methods

This multicenter, prospective, observational real-world study in the Czech Republic and Slovakia evaluated the baseline characteristics and clinical management of women with postmenopausal osteoporosis prescribed denosumab for 24 months.

Results

A total of 600 women were included (300 in each country). In the Czech Republic and Slovakia, respectively, mean age at enrollment was 69.0 and 64.3 years, 67.7% and 30.0% of patients had a previous osteoporotic fracture, and 85.0% and 48.7% had previously received osteoporosis medication. In both countries, ‘low BMD T score’ and ‘a history of osteoporotic fracture’ were the main reasons for prescribing denosumab. Most patients received all four post-baseline denosumab injections (Czech Republic, 82.0%; Slovakia, 81.0%), and more than 98% of patients in both countries received all injections at the prescribing center. At 24 months, most patients experienced an increase in BMD T score for the lumbar spine, total hip, or femoral neck (Czech Republic, 69.7–91.7%; Slovakia, 67.1–92.9%). Adverse drug reactions were consistent with the known safety profile of denosumab.

Conclusion

Baseline characteristics of patients receiving denosumab in the Czech Republic and Slovakia reflect the reimbursement criteria for this agent in each country. The findings of our study in patients who are at high risk for fracture are consistent with the growing body of evidence demonstrating the effectiveness of denosumab in real-world clinical practice.

Trial Registration

ClinicalTrials.gov identifier, NCT01652690.

Funding

Amgen Inc.

     

Tarsal navicular stress fractures

Purpose of review

Navicular stress fractures are common in athletes and management is debated. This article will review the evaluation and management of navicular stress fractures.

Recent findings

Various operative and non-operative adjunctive treatment modalities are reviewed including the relevance of vitamin D levels, use of shock wave therapy and bone marrow aspirate concentrate (BMAC), and administration of teriparatide. Surgical treatment may be associated with earlier return to sports.

Summary

The author’s preferred treatment algorithm with corresponding images is presented which allows for safe and rapid return to activities in the athletic patient. Future research is needed in evaluating the preventative effects of vitamin D and use of other adjunctive treatments to increase the healing rates of this fracture.

     

Limited Approaches to Calcaneal Fractures

Purpose of Review

To review literature published in the last 3 years related to minimally invasive approaches to calcaneal fracture fixation.

Recent Findings

Numerous randomized control trials, cohort studies, and meta-analyses have been done in the last 3 years comparing surgical treatment of calcaneus fractures. These studies indicate minimally invasive procedures decrease wound complication rates and achieve similar radiographic and clinical outcomes to open reduction internal fixation. In comparing different surgical treatment methods to non-operative treatment, operative management has increased complication rates but may lead to better functional outcomes in certain patient populations.

Summary

Optimal treatment for displaced intra-articular calcaneus fractures continues to be debated. Current literature would suggest that the decision to operate be based on patient and fracture characteristics and surgeon capabilities. Minimally invasive techniques aim to improve patient reported outcomes and quality of life while decreasing complications and offer another option for surgeons in the treatment of displaced intra-articular calcaneal fractures.

     

Distal radius fractures in the athlete

Purpose of Review

Distal radius fractures are one of the most common upper extremity fractures. Athletes with distal radius fractures are treated according to the same principles as non-athletes but present several unique considerations. At all levels of sport, injured athletes desire to return to play as rapidly as possible.

Recent Findings

Earlier operative fixation may allow an athlete to return to play more quickly. Volar locking plates are most commonly used for operative treatment of distal radius fractures due to their stability and low incidence of complications.

Summary

Although the majority of distal radius fractures in athletes are treated non-operatively, operative intervention is offered when required to restore and maintain acceptable skeletal alignment. Return to sport is individualized guided by fracture stability, athlete age, and wrist-specific demands for competition.

     

Navigation system for robot-assisted intra-articular lower-limb fracture surgery

Purpose

In the surgical treatment for lower-leg intra-articular fractures, the fragments have to be positioned and aligned to reconstruct the fractured bone as precisely as possible, to allow the joint to function correctly again. Standard procedures use 2D radiographs to estimate the desired reduction position of bone fragments. However, optimal correction in a 3D space requires 3D imaging. This paper introduces a new navigation system that uses pre-operative planning based on 3D CT data and intra-operative 3D guidance to virtually reduce lower-limb intra-articular fractures. Physical reduction in the fractures is then performed by our robotic system based on the virtual reduction.

Methods

3D models of bone fragments are segmented from CT scan. Fragments are pre-operatively visualized on the screen and virtually manipulated by the surgeon through a dedicated GUI to achieve the virtual reduction in the fracture. Intra-operatively, the actual position of the bone fragments is provided by an optical tracker enabling real-time 3D guidance. The motion commands for the robot connected to the bone fragment are generated, and the fracture physically reduced based on the surgeon’s virtual reduction. To test the system, four femur models were fractured to obtain four different distal femur fracture types. Each one of them was subsequently reduced 20 times by a surgeon using our system.

Results

The navigation system allowed an orthopaedic surgeon to virtually reduce the fracture with a maximum residual positioning error of \(0.95 \pm 0.3\,\hbox {mm}\) (translational) and \(1.4^{\circ } \pm 0.5^{\circ }\) (rotational). Correspondent physical reductions resulted in an accuracy of 1.03 ± 0.2 mm and \(1.56^{\circ }\pm 0.1^{\circ }\), when the robot reduced the fracture.

Conclusions

Experimental outcome demonstrates the accuracy and effectiveness of the proposed navigation system, presenting a fracture reduction accuracy of about 1 mm and \(1.5^{\circ }\), and meeting the clinical requirements for distal femur fracture reduction procedures.

     

Olanzapine vs haloperidol: treating delirium in a critical care setting

Objective

To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.

Design

Prospective randomized trial

Setting

Tertiary care university affiliated critical care unit.

Patients

All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.

Interventions

Patients were randomized to receive either enteral olanzapine or haloperidol.

Measurements

Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.

Main results

Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.

Conclusions

Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.

     

Vision-based real-time position control of a semi-automated system for robot-assisted joint fracture surgery

Purpose

Joint fracture surgery quality can be improved by robotic system with high-accuracy and high-repeatability fracture fragment manipulation. A new real-time vision-based system for fragment manipulation during robot-assisted fracture surgery was developed and tested.

Methods

The control strategy was accomplished by merging fast open-loop control with vision-based control. This two-phase process is designed to eliminate the open-loop positioning errors by closing the control loop using visual feedback provided by an optical tracking system. Evaluation of the control system accuracy was performed using robot positioning trials, and fracture reduction accuracy was tested in trials on ex vivo porcine model.

Results

The system resulted in high fracture reduction reliability with a reduction accuracy of 0.09 mm (translations) and of \(0.15^{\circ }\) (rotations), maximum observed errors in the order of 0.12 mm (translations) and of \(0.18^{\circ }\) (rotations), and a reduction repeatability of 0.02 mm and \(0.03^{\circ }\).

Conclusions

The proposed vision-based system was shown to be effective and suitable for real joint fracture surgical procedures, contributing a potential improvement of their quality.

     

Special Considerations in the Management of Diabetic Ankle Fractures

Purpose of Review

Ankle fractures and diabetes mellitus are both increasing in prevalence. Patients with both diabetes and an ankle fracture have been shown to have an increased rate of complications which can be catastrophic. The purposes of this review are to identify factors placing patients at an increased risk and offer guidance on the management of these injuries, in order to reduce potential complications.

Recent Findings

Non-operative management of unstable ankle fractures in patients with diabetes results in an unacceptably high rate of complications. Operatively managed patients with uncomplicated diabetes seem to fair as well as patients without diabetes. Thus, it is important to recognize patients as either complicated or uncomplicated at the onset of their treatment based on comorbidities.

Summary

There is limited evidence to guide the management of ankle fractures in patients with diabetes, in particular those deemed complicated. Non-operative management of unstable fractures in diabetic patients should be avoided.

     

The Association Between Overactive Bladder and Falls and Fractures: A Systematic Review

Introduction

Urinary symptoms are associated with an increased risk of falls, but few studies have focused on patients with overactive bladder (OAB). This study aimed to synthesize estimates of the risk of falls and fractures in patients with OAB.

Methods

Medline, EMBASE, the Cumulative Index to Nursing and Allied Health Literature, and Scopus were systematically searched for observational studies that focused on patients with OAB. When available, data from a non-OAB comparison sample were included. Double independent review and data extraction were performed. Falls and fractures data were summarized by unadjusted and adjusted risks, and percent attributable risk (PAR) of falls and fractures associated with OAB.

Results

Fifteen studies were included in the analyses. The proportion of patients with OAB experiencing at least one fall over a year ranged from 18.9% to 50.0%, and the proportion of patients with OAB experiencing recurrent or serious falls ranged from 10.2% to 56.0%. In studies that included a non-OAB comparison sample, a higher risk of falls was observed in patients with OAB compared to those without. A significantly increased (1.3- to 2.3-fold) adjusted OAB-associated risk of falls was reported, while unadjusted PARs for OAB associated falls ranged from 3.7% to 15.5%. Risk was higher among women and those 65 years of age or older. While analysis of fractures showed elevated point estimates, most studies were underpowered to detect a statistically significant difference between groups.

Conclusions

Evidence from the published literature clearly demonstrates the importance of OAB and its symptoms as risk factors for falls and fractures.

Funding

Astellas.

     

Femoroazetabuläres Impingement

Background

There is a high prevalence of femoroacetabular impingement (FAI) in the population and it is associated with an increased risk for the development of coxarthrosis, particularly in impact sports (2–8 times).

Material and methods

Methods for screening and prevention of FAI and their application are demonstrated. Cross-sectional and longitudinal cohort studies are presented in this article and expert recommendations and meta-analyses are discussed.

Results

The development of a cam FAI and also the formation of secondary hip arthritis can (and should) be prevented by avoidance of certain impact sports (training methods) during the skeletal growth phase. The internal rotation of the hips during flexion is a useful screening test to identify individuals with FAI. A recently developed specific examination chair has clearly improved the precision of this test compared to the classical clinical test.

Conclusion

The prevention of FAI and secondary hip arthritis may occur at two levels: during the sensitive (prepubertal) phase the development of FAI can (should) be prevented by avoiding activities that potentially injure the growth plate of the femoral head. Furthermore, screening tests could enable early detection of patients with FAI. These individuals could (should) be advised regarding appropriate behavioral modifications and treatment options depending on the symptoms.

     

Lymphedema self-care in patients with head and neck cancer: a qualitative study

Purpose

Lymphedema is a frequent side effect from head and neck cancer and/or its treatment. As a chronic and progressive condition, it requires an individual’s long-term involvement in self-care for management of lymphedema. This study aimed to report head and neck cancer patients’ perceived lymphedema education, self-care practices, and suggestions related to self-care of head and neck lymphedema.

Methods

Twenty head and neck cancer patients who completed lymphedema therapy participated in semi-structured face-to-face interviews. Interviews were audio-recorded and transcribed. Content analysis was used to analyze the interview data.

Results

All participants reported that they were educated about self-care activities for lymphedema management by their lymphedema therapists. Although most participants (n = 16, 80 %) expressed positive comments about lymphedema self-care education, some participants (n = 7, 35 %) described issues related to lymphedema self-care education. A majority of the participants (n = 17, 85 %) reported that they were conducting some lymphedema self-care activities; nonetheless, more than half of the participants (n = 11, 55 %) delineated barriers for diminished lymphedema self-care activities over time. Participants further indicated suggestions for improving and ensuring consistency of lymphedema self-care.

Conclusions

Opportunities exist to improve lymphedema self-care in head and neck cancer patients. Healthcare professionals should focus on delivering high quality and targeted information about self-care for management of head and neck lymphedema. Interventional research is warranted to address gaps in long-term self-care of head and neck lymphedema.

     

Zone II and III fifth metatarsal fractures in athletes

Purpose of review

This study aimed to review indications, complications, and outcomes of zone II and III fifth metatarsal fractures based on recent literature.

Recent findings

High rates of nonunion, delayed union, and refracture in athletes treated non-operatively. The standard of care is operative treatment in athletes with intramedullary fixation.

Summary

Operative treatment of zone II and III fractures in athletes will decrease the risk of nonunion and refracture while leading to an earlier return to play.

     

Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60–150 cc)

Introduction

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

Methods

Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

Results

One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Q_max increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.

Conclusion

Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

Trial Registration

ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.

Funding

PROCEPT BioRobotics.

     

Aspekte einer liaisonpsychiatrischen Betreuung von Patienten einer universitären Schmerzambulanz

Background

Owing to a rise of psychosomatic comorbidities, the treatment of psychological disorders, which may negatively impact prognosis and therapy, is increasingly becoming a focus of attention for pain outpatient clinics.

Aim

This study investigates and discusses the advantages of liaison psychiatric care in a university pain clinic.

Methods

In this retrospective study, we investigated all patients who presented to an anaesthesiologically led pain clinic between January and June 2014. The psychiatric history was taken by the liaison psychiatrist of the pain clinic.

Results

In the period investigated, 485 patients were treated as outpatients. A psychiatric diagnosis was present 351 patients (72.4%). The distribution of the diagnoses was comparable with that of a consultation service. Adaptation and affective disorders dominated. The patients were preferentially treated with new generation antidepressants.

Conclusion

The constant presence of a liaison psychiatrist allows for timely, specialised care of pain patients in terms of a multimodal therapeutic approach.

     

Arthroskopische Therapie der Kniesteife

Background

Knees with a limited range of motion caused by intraarticular scars benefit from arthroscopic arthrolysis. Usually these scars result from previous surgery, severe trauma with damage of intraarticular structures.

Objectives

The aim of this procedure is to improve the patients’ range of motion which is necessary for activities of work and daily life. Scar tissue is debrided and resected arthroscopically with a radiofrequency device, a shaver or a punch.

Indications

Indications are a flexion deficit of max. 40°, an extension deficit of max. 20°, reduced mobility of patella, intraarticular reason for limited range of motion, cyclops after anterior cruciate liagment reconstruction, fibrotic Hoffa fat pad.

Contraindications

Contraindications are an extraarticular origin of limited range of motion (e.?g. fibrotic quadriceps muscle), local and general infection, major osteoarthritis, noncompliance, complex regional pain syndrome type I.

Postoperative management

A continuous physical therapy to maintain range of motion is essential. If necessary, continuous passive motion is implemented. Pain adapted weight-bearing should be used for mobilization. A sufficient oral and (when indicated) regional pain management is important to guarantee the benefit of the surgery.

Results

Patients with a lack of mobility of the knee gain a significantly increased range of motion by this arthroscopic procedure. Because of the minimal invasiveness, trauma of surgery and risk of infection are reduced. In many cases the function of the knee joint can be completely restored or at least improved considerably. Complications such as early osteoarthritis can be avoided.

     

Local Injection of Bone Mesenchymal Stem Cells and Fibrin Glue Promotes the Repair of Bone Atrophic Nonunion In Vivo

Introduction

This study aimed to evaluate the efficacy of local injection of bone mesenchymal stem cells (BMSCs) and fibrin glue in the treatment of atrophic nonunion in an animal model.

Methods

Thirty-six male Lewis rats were randomly assigned into three groups: Group A (control group), Group B (atrophic nonunion group), and Group C (experimental group). All the rats underwent femoral osteotomy of the right hind limb, and stabilized with a custom-designed external fixator. Atrophic nonunion of the rats in Group B and C was induced by cauterization of the periosteum and bone marrow removal, and repaired by injection of fibrin glue and BMSCs-seeded fibrin glue, respectively. The surgically treated femurs were assessed by radiographic and histological analysis, and biomechanical test.

Results

During the follow-up period, the external fixator maintained correct placement and all the femurs retained normal positioning. Eight weeks postoperatively, atrophic nonunion was detected in Group B, with the presence of fibrous connective tissue in the osteotomy gap. The femurs in Group C demonstrated complete bony bridging of the osteotomy gap, with the formation of plenty of woven bone.

Conclusion

The repair of bone atrophic nonunion can be promoted through local injection of BMSCs and fibrin glue.