Comparison of 3-year local control using DAHANCA radiotherapy guidelines before and after implementation of five millimetres geometrical GTV to high-dose CTV margin.

INTRODUCTION: Treatment planning using a five-millimetre geometrical margin from GTV to high-dose CTV (CTV1) has been used in DAHANCA treatment centres since 2013. We aimed to evaluate changes in CTV1 volumes, local control (LC), and recurrence pattern after the implementation of five-millimetre geometrical margins nationally. MATERIALS AND METHODS: 1,948 patients with pharyngeal, and laryngeal squamous cell carcinomas completed definitive IMRT-based treatment in 2010-2012 and 2013-2015 in three centres. The patient-specific margin was calculated as median surface distance from primary tumour GTV (GTV-T) to CTV1. Radiologically verified local recurrences were analysed using a centre of mass (COM) of the delineated recurrence volume, measuring the shortest distance between COM to GTV-T and CTV1 boundaries. RESULTS: Median GTV-CTV1 was 0.9 (0.0-0.97) and 0.47 cm (0.4-0.5) for 2010-2012 and 2013-2015, respectively. Median CTV1 changed in three centres from 76, 28, 42 cm3 to 61, 53, 62 cm3 for 2010-2012 and 2013-2015, respectively. Local failures occurred at 247 patients during first three years after radiotherapy. The 3-year LC rate for 2010-2012 and 2013-2015 was 0.84 and 0.87 (p = 0.06). Out of 146 radiology-verified analysable local recurrences, 102 (69.9%) were inside the CTV1. In 74.6% and 91% of cases, the LRs were covered by 95% isodose in 2010-2012 and 2013-2015, respectively. CONCLUSION: DAHANCA radiotherapy guidelines based on a geometrically generated isotropic CTV1 margin led to less variation in treatment volumes and between centres than previous guidelines. The transition towards consensus GTV-CTV1 margins did not influence local tumour control. The majority of local recurrences were inside CTV1 and covered by the prescription dose.

The impact of cognitive function on physical activity, physical function and quality of life in older adults following a hip fracture.

OBJECTIVE: To determine the impact of cognitive function on physical activity (PA), physical function and health-related quality of life (HRQoL) in older adults within the first year after hip fracture (HF) surgery. METHODS: We included 397 home-dwelling individuals aged 70 years or older with the ability to walk 10 m before the fracture. Cognitive function was measured at 1 month and other outcomes were assessed at 1, 4 and 12 months postoperatively. Mini-Mental State Examination was used to assess cognitive function, accelerometer-based body-worn sensors to register PA, Short Physical Performance Battery to test physical function and EuroQol-5-dimension-3-level to estimate the HRQoL. Data were analysed by linear mixed-effects models with interactions and ordinal logistic regression models. RESULTS: Cognitive function, adjusted for the pre-fracture ability to perform activities of daily living, comorbidity, age and gender, had an impact on PA [b = 3.64, 95% confidence interval (CI): 2.20-5.23, P < 0.001] and physical function (b = 0.08, 95% CI: 0.04-0.11, P < 0.001; b = 0.12, 95% CI: 0.09-0.15, P < 0.001; and b = 0.14, 95% CI: 0.10-0.18, P < 0.001 at 1, 4 and 12 months, respectively). The cognitive function did not have a considerable impact on HRQoL. CONCLUSIONS: For older adults with HFs, cognitive function 1 month postoperatively had a significant impact on PA and physical function in the first postoperative year. For the HRQoL, little or no evidence of such an effect was found.

Longitudinal trajectories of functional recovery after hip fracture.

BACKGROUND: There is limited evidence regarding predictors of functional trajectories after hip fracture. We aimed to identify groups with different trajectories of functional recovery the first year after hip fracture, and to determine predictors for belonging to such groups. METHODS: This longitudinal study combined data from two large randomized controlled trials including patients with hip fracture. Participants were assessed at baseline, four and 12 months. We used the Nottingham Extended Activities of Daily Living (NEADL) as a measure of instrumental ADL (iADL) and Barthel Index for personal ADL (pADL). A growth mixture model was estimated to identify groups of patients following distinct trajectories of functioning. Baseline characteristics potentially predicting group-belonging were assessed by multiple nominal regression. RESULTS: Among 726 participants (mean age 83.0; 74.7% women), we identified four groups of patients following distinct ADL trajectories. None of the groups regained their pre-fracture ADL. For one of the groups identified in both ADL outcomes, a steep decline in function was shown the first four months after surgery, and none of the groups showed functional recovery between four and 12 months after surgery. CONCLUSIONS: No groups regained their pre-fracture ADL. Some of the patients with relatively high pre-fracture function, had a steep ADL decline. For this group there is a potential for recovery, but more knowledge and research is needed in this group. These findings could be useful in uncovering groups of patients with different functioning after a hip fracture, and aid in discharge planning.

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol.

BACKGROUND: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. METHODS/DESIGN: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. DISCUSSION: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. TRIAL REGISTRATION: ISRCTN12051706.

The Synthesis of 3-(R)- and 3-(S)-Hydroxyeicosapentaenoic Acid.

Monohydroxylated polyunsaturated fatty acids belonging to the oxylipin class of natural products are present in marine and terrestrial sources as well as in the human body. Due to their biological activities and role in diverse biosynthetic pathways, oxylipins biosynthesized from eicosapentaenoic acid and arachidonic acid have attracted great interest from the scientific community. One example is 3-hydroxyeicosapentaenoic acid where the absolute configuration at C-3 has only been tentatively assigned. In this paper, studies on acetate type aldol reactions that enabled the preparation of 3-(R)-hydroxyeicosapentaenoic acid (3R-HETE, 2) and its enantiomer are presented.

Orthogeriatrics prevents functional decline in hip fracture patients: report from two randomized controlled trials.

BACKGROUND: The incidence of hip fractures are expected to increase in the following years. Hip fracture patients have in addition to their fracture often complex medical problems, which constitute a substantial burden on society and health care systems. It is thus important to optimize the treatment of these patients to reduce negative outcomes. The aim of this study was to assess the effect of comprehensive orthogeriatric care (CGC) on basic and instrumental activities of daily living (B-ADL and I-ADL). METHODS: This study is based on two randomized controlled trials; the Oslo Orthogeriatric Trial and the Trondheim Hip Fracture Trial. The two studies were planned in concert, and data were pooled and analyzed using linear mixed models. I-ADL function was assessed by the Nottingham Extended ADL Scale (NEADL) and B-ADL by the Barthel ADL (BADL) at four and twelve months after surgery. RESULTS: Seven hundred twenty-six patients were included in the combined database, of which 365 patients received OC and 361 patients received CGC. For the primary endpoint, I-ADL at four months was better in the CGC group, with a between-group difference of 3.56 points (95 % CI 0.93 to 6.20, p = 0.008). The between-group difference at 12 months was 4.28 points (95 % CI 1.57 to 7.00, p = 0.002). For B-ADL, between-group difference scores were only statistically significant at 12 months. When excluding the patients living at a nursing home at admission, both I-ADL and B-ADL function was significantly better in the CGC group compared to the OC group at all time points. CONCLUSIONS: Merged data of two randomized controlled trials showed that admitting hip fracture patients to an orthogeriatric care unit directly from the emergency department had a positive effect on ADL up to twelve months after surgery.

Health care services and costs after hip fracture, comparing conventional versus standardised care: A retrospective study with 12-month follow-up.

AIMS: To compare costs related to a standardised versus conventional hospital care for older patients after fragility hip fracture and determine whether a shift in hospital care led to cost-shifts between specialists and primary health care. METHODS: We retrospectively collected and calculated volumes of care and accompanying costs from fracture time until 12 months after hospital discharge for 979 patients. All patients aged ≥ 65 years had fragility hip fractures. The data set had few missing data points because of the patient registry, administrative databases, and a low migration rate. RESULTS: Total costs per patient at 12 months were EUR 78 164 (standard deviation [SD] 58 056) and EUR 78 068 (SD 60 131) for conventional and standardised care, respectively (p = 0.480). Total specialist care costs were significantly lower for the standardised care group (p < 0.001). Total primary care costs were higher for the standardised care group (p = 0.424). Total costs per day of life for the conventional and standardised care groups were EUR 434 and EUR 371, respectively (p = 0.003). Patients in the standardised care group had 17 more days of life. CONCLUSIONS: Implementation of a standardised care to improve outcomes for patients with hip fracture caused lower specialist care costs and higher primary care costs, indicating care- and cost-shifts from specialist to primary health care.

High volumes of recent surgical admissions, time to surgery, and 60-day mortality.

AIMS: Few studies have investigated potential consequences of strained surgical resources. The aim of this cohort study was to assess whether a high proportion of concurrent acute surgical admissions, tying up hospital surgical capacity, may lead to delayed surgery and affect mortality for hip fracture patients. METHODS: This study investigated time to surgery and 60-day post-admission death of patients 70 years and older admitted for acute hip fracture surgery in Norway between 2008 and 2016. The proportion of hospital capacity being occupied by newly admitted surgical patients was used as the exposure. Hip fracture patients admitted during periods of high proportion of recent admissions were compared with hip fracture patients admitted at the same hospital during the same month, on similar weekdays, and times of the day with fewer admissions. RESULTS: Among 60,072 patients, mean age was 84.6 years (SD 6.8), 78% were females, and median time to surgery was 20 hours (IQR 11 to 29). Overall, 14% (8,464) were dead 60 days after admission. A high (75th percentile) proportion of recent surgical admission compared to a low (25th percentile) proportion resulted in 20% longer time to surgery (95% confidence interval (CI) 16 to 25) and 20% higher 60-day mortality (hazard ratio 1.2, 95% CI 1.1 to 1.4). CONCLUSION: A high volume of recently admitted acute surgical patients, indicating probable competition for surgical resources, was associated with delayed surgery and increased 60-day mortality. Cite this article: Bone Joint J 2021;103-B(2):264-270.

Hospitals´ Discharge Tendency and Risk of Death - An Analysis of 60,000 Norwegian Hip Fracture Patients.

PURPOSE: A reduction in the length of hospital stay may threaten patient safety. This study aimed to estimate the effect of organizational pressure to discharge on 60-day mortality among hip fracture patients. PATIENTS AND METHODS: In this cohort study, hip fracture patients were analyzed as if they were enrolled in a sequence of trials for discharge. A hospital's discharge tendency was defined as the proportion of patients with other acute conditions who were discharged on a given day. Because the hospital's tendency to discharge would affect hip fracture patients in an essentially random manner, this exposure could be regarded as analogous to being randomized to treatment in a clinical trial. The study population consisted of 59,971 Norwegian patients with hip fractures, hospitalized between 2008 and 2016, aged 70 years and older. To calculate the hospital discharge tendency for a given day, we used data from all 5,013,773 other acute hospitalizations in the study period. RESULTS: The probability of discharge among hip fracture patients increased by 5.5 percentage points (95% confidence interval (CI)=5.3-5.7) per 10 percentage points increase in hospital discharges of patients with other acute conditions. The increased risk of death that could be attributed to a discharge from organizational causes was estimated to 3.7 percentage points (95% CI=1.4-6.0). The results remained stable under different time adjustments, follow-up periods, and age cut-offs. CONCLUSION: This study showed that discharges from organizational causes may increase the risk of death among hip fracture patients.

Effect of Early Interdisciplinary Rehabilitation for Trauma Patients: A Systematic Review.

OBJECTIVE: To perform a systematic review to assess the current scientific evidence concerning the effect of EIR for trauma patients with or without an associated traumatic brain injury. DATA SOURCE: We performed a systematic search of several electronic (Ovid MEDLINE, Embase, Cochrane Library Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health, and SveMed+) and 2 clinical trial registers (clinicaltrials.gov and International Clinical Trials Registry Platform). In addition, we handsearched reference lists from relevant studies. DATA EXTRACTION: Two review authors independently identified studies that were eligible for inclusion. The primary outcome measures were functional-related outcomes and return to work. The secondary outcome measures were length of stay in hospital, number of days on respirator, complication rate, physical and mental health measures, quality of life, and socioeconomic costs. DATA SYNTHESIS: Four studies with a total number of 409 subjects, all with traumatic brain-associated injuries, were included in this review. The included trials varied considerably in study design, inclusion and exclusion criteria, and had small numbers of participants. All studies were judged to have at least 1 high risk of bias. We found the quality of evidence, for both our primary and secondary outcomes, low. CONCLUSIONS: No studies that matched our inclusion criteria for EIR for trauma patients without traumatic brain injuries could be found. For traumatic brain injuries, there are a limited number of studies demonstrating that EIR has a positive effect on functional outcomes and socioeconomic costs. This review highlights the need for further research in trauma care regarding early phase interdisciplinary rehabilitation.

A prospective randomized trial of 100 patients using trochanteric support plates; worth their mettle?

BACKGROUND AND PURPOSE: To compare the radiological and clinical results of sliding hip screw (SHS) fixation with or without a Trochanteric Support Plate (TSP) on unstable three-or-more-part trochanteric fractures. METHODS: A randomized prospective non blinded study of one hundred patients with trochanteric fractures; Evans-Jensen type 3, 4 and 5, reduced and fixed with SHS. Patients were randomized into two study groups; with or without TSP supplementation ('TSP' and 'NoTSP' groups). Radiologic measurements of the hip in the frontal plane (primary outcome), including fracture movement, nonunion and loss of fixation were measured, as well as pain, ambulation, mobility, institution residence, complications and death, twelve months post operatively (secondary outcomes). RESULTS: At one-year follow-up four patients in the TSP and ten patients in the NoTSP group had either died or been lost in follow-up. Within this period, forty-three fractures healed and three had a loss of fixation in the TSP group; thirty-nine fractures healed and one had a loss of fixation in the NoTSP group. Frontal X-rays showed fracture subsidence on average 1 mm less in the TSP group compared to the NoTSP group. This difference was negligible, as was the difference in all subgroups, in fixation failure/cutout, modified Merle d'Aubigne Postel scores (measuring function and pain), institution residence, complications and death between the groups. INTERPRETATION: This study cannot confirm that TSP has any beneficial effects on unstable three-or-more-part trochanteric fractures. If any effect at all, the difference is most likely slight and clinically irrelevant.

Awareness and surveillance of radiation treatment schedules reduces head and neck overall treatment time.

BACKGROUND AND PURPOSE: Overall treatment time (OTT) is essential for local tumour control and survival in radiotherapy of head and neck cancer (HNC). National radiotherapy guidelines of the Danish Head and Neck Cancer Group (DAHANCA) recommend a maximum OTT of 41 days for moderately accelerated radiation treatment (6 fractions/week) and 48 days for conventional treatment (5 fractions/week). The purpose of this study was to evaluate the effect of surveillance of the radiotherapy course length and treatment gaps in HNC patients to reduce OTT. METHODS: The study included 2011 patients with HNC undergoing radical radiation treatment with 66-68 Gy in 33-34 fractions in 2003-2017 at Odense University Hospital. In February 2016, a systematic weekly review by two radiation therapists of all planned treatment courses was introduced to check OTT of individual patients to portend likely breaks or treatment prolongations. Schedules that violated the OTT guidelines were conferred with the responsible radiation oncologist, and treatment rescheduled by treating twice daily to catch up with a delay. RESULTS: The mean length of accelerated treatment courses was reduced from a maximum of 40.9 days in 2007 to 38.3 days in 2017 and from 50.3 days to 45.9 days for conventional courses. The percentage of individual treatment courses that violated the recommended OTT was reduced to 3% of the accelerated treatments and 13% for the conventional treatments. CONCLUSION: Continuous surveillance of treatment schedules of HNC patients by a brief weekly survey reduced treatment course duration to an extent that was radiobiologically and clinically meaningful.

Time of admission and mortality after hip fracture: a detailed look at the weekend effect in a nationwide study of 55,211 hip fracture patients in Norway.

Background and purpose - There are numerous studies on the weekend effect for hip fracture patients, with conflicting results. We analyzed time of admission and discharge, and the association with mortality and length of hospital stay in more detail. Patients and methods - We used data from 61,211 surgically treated hip fractures in 55,211 patients, admitted to Norwegian hospitals 2008-2014. All patients were aged 50 years or older. Data were analyzed with Cox and Poisson regression. Results - Mortality within 30 days did not differ substantially by day of admission, although admissions on Sundays and holidays had a slightly increased mortality. The hazard ratios were 1.1 (95% confidence interval [CI] 0.97-1.2) for Sundays, and 1.2 (CI 0.98-1.4) for holidays, relative to Mondays. For patients admitted between 6:00 am and 7:00 am the hazard ratio was 1.4 (CI 1.1-1.8) relative to patients admitted between 2:00 pm and 3:00 pm. Discharges during weekends and holidays were associated with a substantial higher mortality than weekday discharges. Patients admitted from Friday to Sunday generally stayed in hospital for a shorter time than patients admitted during other days. Interpretation - Our results indicate that the discussion on weekday versus weekend admission effects might have distracted attention from other important factors, such as time of day of admission, and day of discharge from hospital treatment.

Mortality and readmission following hip fracture surgery: a retrospective study comparing conventional and fast-track care.

OBJECTIVE: To compare the efficacies of two pathways-conventional and fast-track care-in patients with hip fracture. DESIGN: Retrospective single-centre study. SETTING: University hospital in middle Norway. PARTICIPANTS: 1820 patients aged ≥65 years with hip fracture (intracapsular, intertrochanteric or subtrochanteric). INTERVENTIONS: 788 patients were treated according to conventional care from April 2008 to September 2011, and 1032 patients were treated according to fast-track care from October 2011 to December 2013. PRIMARY AND SECONDARY OUTCOME: Primary: mortality and readmission to hospital, within 365 days follow-up. Secondary: length of stay. RESULTS: We found no statistically significant differences in mortality and readmission rate between patients in the fast-track and conventional care models within 365 days after the initial hospital admission. The conventional care group had a higher, no statistical significant mortality HR of 1.10 (95% CI 0.91 to 1.31, p=0.326) without and 1.16 (95% CI 0.96 to 1.40, p=0.118) with covariate adjustment. Regarding the readmission, the conventional care group sub-HR was 1.02 (95% CI 0.88 to 1.18, p=0.822) without and 0.97 (95% CI 0.83 to 1.12, p=0.644) with adjusting for covariates. Length of stay and time to surgery was statistically significant shorter for patients who received fast-track care, a mean difference of 3.4 days and 6 hours, respectively. There was no statistically significant difference in sex, type of fracture, age or Charlson Comorbidity Index score at baseline between patients in the two pathways. CONCLUSIONS: There was insufficient evidence to show an impact of fast-track care on mortality and readmission. Length of stay and time to surgery were decreased. TRIAL REGISTRATION NUMBER: NCT00667914; results.

Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial.

BACKGROUND CONTEXT: Lumbar total disc replacement (TDR) is a treatment option for selected patients with chronic low back pain (LBP) that is non-responsive to conservative treatment. The long-term results of disc replacement compared with multidisciplinary rehabilitation (MDR) have not been reported previously. PURPOSE: We aimed to assess the long-term relative efficacy of lumbar TDR compared with MDR. DESIGN: We undertook a multicenter randomized controlled trial at five university hospitals in Norway. PATIENT SAMPLE: The sample consisted of 173 patients aged 25-55 years with chronic LBP and localized degenerative changes in the lumbar intervertebral discs. OUTCOME MEASURES: The primary outcome was self-reported physical function (Oswestry Disability Index [ODI]) at 8-year follow-up in the intention-to-treat population. Secondary outcomes included self-reported LBP (visual analogue scale [VAS]), quality of life (EuroQol [EQ-5D]), emotional distress (Hopkins Symptom Checklist [HSCL-25]), occupational status, patient satisfaction, drug use, complications, and additional back surgery. METHODS: Patients were randomly assigned to lumbar TDR or MDR. Self-reported outcome measures were collected 8 years after treatment. The study was powered to detect a difference of 10 ODI points between the groups. The study has not been funded by the industry. RESULTS: A total of 605 patients were screened for eligibility, of whom 173 were randomly assigned treatment. Seventy-seven patients (90%) randomized to surgery and 74 patients (85%) randomized to rehabilitation responded at 8-year follow-up. Mean improvement in the ODI was 20.0 points (95% confidence interval [CI] 16.4-23.6, p≤.0001) in the surgery group and 14.4 points (95% CI 10.7-18.1, p≤.0001) in the rehabilitation group. Mean difference between the groups at 8-year follow-up was 6.1 points (95% CI 1.2-11.0, p=.02). Mean difference in favor of surgery on secondary outcomes were 9.9 points on VAS (95% CI 0.6-19.2, p=.04) and 0.16 points on HSCL-25 (95% CI 0.01-0.32, p=.04). There were 18 patients (24%) in the surgery group and 4 patients (6%) in the rehabilitation group who reported full recovery (p=.002). There were no significant differences between the groups in EQ-5D, occupational status, satisfaction with care, or drug use. In the per protocol analysis, the mean difference between groups was 8.1 ODI points (95% CI 2.3-13.9, p=.01) in favor of surgery. Forty-three of 61 patients (70%) in the surgery group and 26 of 52 patients (50%) in the rehabilitation group had a clinically important improvement (15 ODI points or more) from baseline (p=.03). The proportion of patients with a clinically important deterioration (six ODI points or more) was not significantly different between the groups. Twenty-one patients (24%) randomized to rehabilitation had crossed over and had undergone back surgery since inclusion, whereas 12 patients (14%) randomized to surgery had undergone additional back surgery. One serious adverse event after disc replacement is registered (<1%). CONCLUSIONS: Substantial long-term improvement can be expected after both disc replacement and MDR. The difference between groups is statistically significant in favor of surgery, but smaller than the prespecified clinically important difference of 10 ODI points that the study was designed to detect. Future research should aim to improve selection criteria for disc replacement and MDR.

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.

PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19.

Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT).

PURPOSE: Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. METHODS: Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. RESULTS: Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. CONCLUSION: High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

Medication reconciliation of patients with hip fracture by clinical pharmacists.

OBJECTIVE: Medication reconciliation is a strategy for reducing medication discrepancies and improving patient safety. Transitions through different levels of care contribute to medication discrepancies caused by lack of communication. In October 2011, St Olav's Hospital initiated a fast-track model for patients with hip fractures, where clinical pharmacists (CPs) are a part of a multidisciplinary team. The purpose of this study was to examine discrepancies discovered in medication lists by CPs at the orthopaedic ward and consider their clinical relevance. METHOD: This prospective study was conducted at an orthopaedic ward at St Olav's Hospital in the period October 2011-August 2012. Medication reconciliation by CPs was done for all patients with a hip fracture using a systematic method. Information was obtained by the CP by interview with the patient and additional sources, for example, medication list from general practitioner and nursing home. An independent expert group consisting of a geriatrician, an orthopaedist and a CP considered level of clinical relevance of the discrepancies found in the collected data. RESULTS: A total of 410 discrepancies were registered for all 317 patients, Discrepancies were found in 159 (50%) patients with an average of 2.6 per patient affected. Of the total amount of discrepancies, the expert group evaluated 68% and 19% as potentially moderate and severe, respectively, if they were unattended during hospitalisation and after discharge. CONCLUSIONS: By using CPs in medication reconciliation at orthopaedic wards, discrepancies that can lead to serious discomfort or clinical deterioration of patients can be avoided.