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52 result(s) for "Østergaard, Helle"
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Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3–4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial
Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely. In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments. ClinicalTrials.gov NCT01246167.
Nonoperative treatment versus volar locking plating for distal radius fracture in patients aged 65 years or older (DRIFT trial): A randomized controlled trial
The optimal management of distal radius fractures (DRFs) in older patients remains debatable. A knowledge gap exists concerning how to manage fractures with early malalignment during nonoperative treatment. We conducted a prospective, multicenter, and randomized controlled trial to compare nonoperative treatment to operative treatment with volar locking plating (VLP) in the management of primarily malaligned DRFs and DRFs that exhibit early malalignment during nonoperative treatment. The DRIFT trial was conducted at five trauma centers in Finland, Sweden, and Denmark. Patients aged 65 years or older with a dorsally displaced AO-type A or C DRF were included in the trial. Patients with DRF who did not maintain alignment after closed reduction (CR) were randomized in 1:1 ratio to nonoperative treatment or VLP. Patients with acceptable alignment after CR visited the outpatient clinic 5-10 days after CR. If the alignment was lost, the patients were randomized in 1:1 ratio to either continue nonoperative treatment or to VLP. The primary outcome measure was Patient Rated Wrist Evaluation (PRWE) at 12 months. The primary analysis method for PRWE was a linear mixed model. In the linear mixed model, patient was a random factor and age and intra/extra articularity of the fracture were fixed. Participants and orthopedic investigators were not blinded. The statisticians and investigators responsible for the analysis remained blinded to the treatment groups during data analysis and the drawing of conclusions. Between March 15, 2018 and June 6, 2023, 291 patients aged 65 years or older (mean age 73 years (standard deviation (SD) 5.8), 258 women, 33 men) who had sustained a DRF were included in the trial. The 12-month follow-up was completed on June 11, 2024. One hundred twenty-four DRFs did not maintain acceptable fracture alignment after CR; 66 were randomized to nonoperative treatment and 58 to VLP. These patients are referred to as primarily malaligned DRFs. Eighty-six patients lost fracture alignment during the first 5-10 days of follow-up; 44 patients were randomized to continue nonoperative treatment, and 42 patients to VLP. These patients are referred to as early malaligned DRFs. In primarily malaligned DRFs, the estimated mean effect for PRWE at 12 months was -9.6 points (95% confidence interval (CI) [-17.4, -1.7]; p = 0.0178) in favor of VLP, which is smaller than the predefined minimal clinically important difference (MCID) of the PRWE (11 points). In early malaligned DRFs, the mean effect for PRWE at 12 months was -6.2 points (95% CI [-15.4, 3.0]; p = 0.1816). At 12-month follow-up, we found 25 treatment-related adverse events (AE) (10/66, 15% in primarily malaligned DRFs nonoperative; 5/58, 8.6% in primarily malaligned DRFs operative; 2/44, 4.5% in early malaligned DRFs nonoperative; 3/42, 7.1% in early malaligned DRFs operative; 5/63, 7.9% in well-aligned DRFs) and 11 other AE. The trial recruitment period was longer than expected due to the restrictions caused by the global COVID-19 pandemic. Due to the decreased inclusion rate, we had to cease the recruitment of patients with early malaligned DRF before reaching the predefined 57 patients per Arm, which was the main limitation of the trial. Operative treatment of primarily malaligned DRF with VLP may slightly improve wrist function at 12 months. The estimated mean difference between the groups was, however, smaller than the predefined MCID of the PRWE (11 points). In DRFs with early loss of alignment, operative treatment does not appear to provide benefit. Our results suggest that the choice of treatment modality should be made following primary fracture reduction because subsequent monitoring of fracture alignment does not offer any additional benefit in terms of expected wrist function. This questions the need for early radiographic follow-up during the nonoperative treatment. The trial was registered at ClinicalTrials.gov (Identifier: NCT02879656, registration date 08/17/2016).
Variations in surgical practice and adverse events following isolated proximal humerus fracture in adults – a comparative longitudinal cohort study of 53,852 patients from Denmark, England, and Sweden
Background Proximal humeral fractures (PHFs) are common injuries, but their management has remained controversial. Recent high-level evidence from randomized clinical trials has shown that for many PHFs, surgical treatment is not superior to non-surgical treatment. Our primary aim was to conduct a multi-nation assessment of temporal trends and changes in surgical treatment of isolated PHF in Denmark, England, and Sweden. A secondary aim was to estimate the incidence of serious adverse events (SAEs) within 30 days (and death within 90 days) of primary surgery. Methods This population-based cohort study presents routinely collected data from Danish, English, and Swedish patient registries and electronic health records from 1998 to 2018. All adult patients with isolated PHFs combined with predefined surgical procedure codes were included. Age- and sex-specific incidence rates (IRs) of surgery and each surgical procedure per calendar year were calculated. Kaplan–Meier plots displayed patient survival for the study period. Incidence proportions of SAEs within 30 days (and death within 90 days) of surgery were computed. Results A total of 54,077 primary surgical procedures, performed in 53,852 patients with isolated PHF, were included. Denmark and Sweden had the highest IR of surgery, with Denmark peaking at 17.4/100,000 person-years in 2011 and Sweden peaking at 18/100,000 person-years in 2013, while England peaked at 5/100,000 person-years in 2010. From 2004, plate fixation was the leading surgical procedure in Denmark and Sweden, while arthroplasty was the most frequent in England. The IR of surgery in Denmark and Sweden was 8–10 times higher for women aged 80 years than that observed in England. The 30-day incidence of SAEs varied between countries, ranging from 0.03% to 3.51%. Conclusions Variations in surgical practice for isolated PHF exist between Denmark, England, and Sweden, with differences in overall IRs of surgery and preferred procedures. A complex interplay between hospitals, surgeons, healthcare systems, and evidence-based factors is likely to explain such variations. However, in all three countries, the IR of surgery, particularly for the use of locking plates, demonstrated a decline from 2013, coinciding with high-quality trials and meta-analyses suggesting that evidence-based factors are becoming more prominent in orthopaedic treatment decisions.
Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients
Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments.
Prevalence and predictors of musculoskeletal pain among Danish fishermen – results from a cross-sectional survey
Background Fishermen work in a physically challenging work environment. The aim of this analysis was to estimate the prevalence and predictors of musculoskeletal pain among Danish fishermen. Method A cross-sectional survey in a random sample of Danish fishermen was done with application of the Nordic questionnaire regarding musculoskeletal pain considering lower back, shoulders, hand neck, knee, upper back elbow, hip and feet. In total, 270 fishermen participated in the study (response rate: 28%). Workload, vessel type, skipper, duration of work, sideline occupation, days/weeks of fishing at sea, age, BMI and education were used as predictors for the overall musculoskeletal pain score (multiple linear regression) and for each single pain site (multinomial logistic regression). Results The prevalence of pain was high for all musculoskeletal locations. Overall, more than 80% of the responding Danish fishermen reported low back pain, which in 37% lasted for a minimum of 30 days during the past year. In the multiple linear regression analysis, middle workload was associated with a 32% (95% CI: 19-46%) and high workload with 60% (95% CI: 46-73%) increased musculoskeletal pain score compared to low work load. Multinomial logistic regression models showed that workload was the only predictor for all pain sites, in particular regarding upper and lower limb pain. Conclusion Although changes were implemented to improve the fishermen’s work environment, the work continues to be physically demanding and impacting their musculoskeletal pain. Potential explanation for this unexpected result like increased work pressure and reduced financial attractiveness in small scale commercial fishery needs to be confirmed in future research.
Melanopsin-mediated pupillary responses in bipolar disorder—a cross-sectional pupillometric investigation
BackgroundVisible light, predominantly in the blue range, affects mood and circadian rhythm partly by activation of the melanopsin-containing intrinsically photosensitive retinal ganglion cells (ipRGCs). The light-induced responses of these ganglion cells can be evaluated by pupillometry. The study aimed to assess the blue light induced pupil constriction in patients with bipolar disorder (BD).MethodsWe investigated the pupillary responses to blue light by chromatic pupillometry in 31 patients with newly diagnosed bipolar disorder, 22 of their unaffected relatives and 35 healthy controls. Mood state was evaluated by interview-based ratings of depressive symptoms (Hamilton Depression Rating Scale) and (hypo-)manic symptoms (Young Mania Rating Scale).ResultsThe ipRGC-mediated pupillary responses did not differ across the three groups, but subgroup analyses showed that patients in remission had reduced ipRGC-mediated responses compared with controls (9%, p = 0.04). Longer illness duration was associated with more pronounced ipRGC-responses (7% increase/10-year illness duration, p = 0.02).ConclusionsThe ipRGC-mediated pupil response to blue light was reduced in euthymic patients compared with controls and increased with longer disease duration. Longitudinal studies are needed to corroborate these potential associations with illness state and/or progression.
Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial
Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded. This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial. ClinicalTrials.gov NCT01246167.
Effect of no reduction versus closed reduction on distal radius fractures in adults aged 65 years and older: a protocol for the DISCLOSE randomised equivalence trial
IntroductionDistal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.Methods and analysisThis is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.Ethics and disseminationEthical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.Protocol version6 July 2025, v1.0.Trial registration numberNCT07042139.
The workload of fishermen: a cross sectional survey among Danish commercial fishermen
Fishery has always been perceived as a physically demanding industry of a manual character. In recent years the physical work environment has developed positively and consequently the current situation in not fully described in the existing literature. This study aims to describe the work environment of Danish fishermen with regard to their physical workload and ergonomic factors. A cross sectional study was performed on a random sample of active Danish commercial fishermen (response rate: 28%) by means of a questionnaire on demographic and self-reported occupational and health data. Questions covering the physical workload were related to seven different work situations and a score summing up the workload was developed for the analysis of the relative impact on different groups of fishermen. Almost all fishermen (96.2%) were familiar to proper lifting techniques but only 55.4% used them in their daily work. Standing work was the most applied work position (81.8%), while repetitive hand and finger movements and twisting and bending in the back were other frequent work situations. Deckhands had higher workload scores than skippers, while crew on Danish seiners had higher workload scores than fishermen in other vessel types. Despite improved work environment in the Danish fishing industry, fishermen still experience high levels of workload and suboptimal ergonomic conditions, which are known to cause pain and impair musculoskeletal health. To address the specific areas of fishing with the highest workload, future investments in assistive devices to ease the demanding work and reduce the workload, should particularly address deckhands and less mechanized vessels.
Mood and behavior seasonality in glaucoma; assessing correlations between seasonality and structure and function of the retinal ganglion cells
In glaucoma, depression and disturbed sleep has been associated with degeneration of the intrinsically photosensitive retinal ganglion cells, that mediate non-image forming effects of light such as regulation of circadian rhythm, alertness and mood. In this study we assessed associations between seasonal mood and behavior variation and retinal ganglion cell damage in outpatients with glaucoma. The seasonal pattern assessment questionnaire was administered to outpatients with glaucoma. Data on visual field defects identified by autoperimetry and retinal nerve fiber layer thickness visualized by ocular coherence tomography were collected from patient charts. The correlations between seasonality and retinal damage were tested and the adjusted effects of retinal function on seasonality were evaluated in a linear regression model. In total, 113 persons completed the questionnaire. Of these, 4% fulfilled the criteria for seasonal affective disorder (SAD) and 8% for subsyndromal seasonal affective disorder (sSAD). Mean global seasonal score was 4.3. There were no significant correlations between seasonality and either visual field or retinal nerve fiber layer thickness. In the adjusted analysis there were trends toward differential effects of visual field on seasonality in subgroups with different sex and type of glaucoma. There were no strong associations between seasonality and visual field or retinal nerve fiber layer thickness. Sex, age and glaucoma subtype may modify light effects on complex regulatory systems.