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author:("berson, Stig")
1.  Patient-reported outcome and risk of revision after shoulder replacement for osteoarthritis 
Acta Orthopaedica  2014;85(2):117-122.
We used patient-reported outcome and risk of revision to compare hemiarthroplasty (HA) with total shoulder arthroplasty (TSA) and stemmed hemiarthroplasty (SHA) with resurfacing hemiarthroplasty (RHA) in patients with glenohumeral osteoarthritis.
Patients and methods
We included all patients reported to the Danish Shoulder Arthroplasty Registry (DSR) between January 2006 and December 2010. 1,209 arthroplasties in 1,109 patients were eligible. Western Ontario Osteoarthritis of the Shoulder index (WOOS) was used to evaluate patient-reported outcome 1 year postoperatively. For simplicity of presentation, the raw scores were converted to a percentage of the maximum score. Revision rates were calculated by checking reported revisions to the DSR until December 2011. WOOS and risk of revision were adjusted for age, sex, previous surgery, and type of osteoarthritis.
There were 113 TSAs and 1096 HAs (837 RHAs and 259 SHAs). Patients treated with TSA generally had a better WOOS, exceeding the predefined minimal clinically important difference, at 1 year (mean difference 10, p < 0.001). RHA had a better WOOS than SHA (mean difference 5, p = 0.02), but the difference did not exceed the minimal clinically important difference. There were no statistically significant differences in revision rate or in adjusted risk of revision between any of the groups.
Our results are in accordance with the results from other national shoulder registries and the results published in systematic reviews favoring TSA in the treatment of glenohumeral osteoarthritis. Nonetheless, this registry study had certain limitations and the results should be interpreted carefully.
PMCID: PMC3967251  PMID: 24650020
2.  Translation and validation of the Western Ontario Osteoarthritis of the Shoulder (WOOS) index – the Danish version 
Background and purpose
The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis. The purpose of this study was to describe the process used to translate the WOOS into Danish and to test the translation in a Danish population, in terms of validity, reliability, and responsiveness.
Material and methods
The translation of the WOOS was done according to international standardized guidelines. The psychometric properties were tested in 20 consecutive patients. The eligibility criteria were: a diagnosis of osteoarthritis without symptomatic rotator cuff pathology and treated with primary shoulder replacement. Patients were excluded only in the case of other pathology of the upper extremity or in the case of cognitive or linguistic impairment compromising the ability to complete the questionnaires.
The Pearson’s correlation coefficient between the WOOS and the Constant-Murley score (CMS), preoperatively was 0.62 (P = 0.004) and the correlation between the changes of score for the WOOS and CMS was 0.73 (P < 0.001). The correlation coefficient between the WOOS and the CMS, SF-36, and the Oxford Shoulder Score postoperatively was 0.82 (P < 0.001), 0.48 (P = 0.03), and 0.82 (P < 0.001), respectively. There were no floor and ceiling effects. The Cronbach’s alpha was 0.98. The intraclass correlation coefficient between test and retest was 0.96. The standardized response mean was 1.41, and effect size was 2.32.
We have shown that the Danish version of the WOOS, translated according to international standardized guidelines, has substantial statistical and clinical psychometric properties at the same level as was described for the original version.
PMCID: PMC3796868  PMID: 24133377
outcome assessment; cross-cultural adaption; questionnaire
3.  Reverse shoulder arthroplasty in acute fractures of the proximal humerus: A systematic review 
The indications for surgical intervention in complex fractures of the proximal humerus are disputed. In elderly patients with poor bone stock it may be impossible to obtain satisfactory fixation of the tuberosities to a hemiarthroplasty (HA). In such cases primary insertion of a reverse shoulder arthroplasty (RSA) has been suggested. We aimed to review clinical studies reporting benefits and harms of RSA in acute fractures. A systematic review. We included 18 studies containing 430 RSA in acute fractures. We found no randomized clinical trials. Four studies compared outcome after RSA with a historical control group of HA. The median constant score was 58 (range 44-68) which is comparable to previous reviews of HA in 4-part fractures. Complications included dislocation, infection, hematoma, instability, neurological injury, reflex sympathetic dystrophy, intraoperative fractures, periprosthetic fractures, and baseplate failure. Scapular notching was reported in 11 studies with a median value of 25% (range 0-94). Heterogeneity of study designs and lack of primary data precluded statistical pooling of data. No high quality evidence was identified. Based on the available evidence the use of RSA in acute fractures is questionable. The complication rate was high and the clinical implications of long term scapular notching are worrying. Randomized studies with long term follow up using the latest techniques of tubercular reinsertion in RSA toward HA should be encouraged.
PMCID: PMC3743034  PMID: 23960366
Proximal humeral fractures; proximal humerus fractures; reverse shoulder arthroplasty; reverse shoulder prosthesis; tuberosity fixation
4.  Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors 
Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales.
We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation.
We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients) with subjective outcomes. The estimated treatment effect was more beneficial when based on nonblinded assessors (pooled difference in effect size −0.23 [95% confidence interval (CI) −0.40 to −0.06]). In relative terms, nonblinded assessors exaggerated the pooled effect size by 68% (95% CI 14% to 230%). Heterogeneity was moderate (I2 = 46%, p = 0.02) and unexplained by metaregression.
We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk of substantial bias.
PMCID: PMC3589328  PMID: 23359047
5.  Translation between the Neer- and the AO/OTA-classification for proximal humeral fractures: do we need to be bilingual to interpret the scientific literature? 
BMC Research Notes  2013;6:69.
The reporting and interpretation of data from clinical trials of proximal humeral fractures are hampered by the use of two partly incommensurable fracture classification systems: the Neer classification and the AO/OTA classification. It remains difficult to interpret and generalize results, to conduct prognostic studies, and to obtain consensus on treatment recommendations when concise definitions and a common ‘fracture language’ are lacking. Thus, we compared both classifications systems using primary data from large clinical studies to assess how thoroughly both systems conveyed clinically important classification information.
Classification data from each study were organized in a cross-table covering the 432 theoretically possible combinations between the 16 Neer categories and the 27 AO/OTA subgroups, and the plausibility of all observed combinations were assessed and discussed by the authors until consensus.
We analyzed primary data from 2530 observations from seven studies providing primary data from both classification systems. Thirty-five percent (151 out of 432) of the combinations were considered ‘not plausible’ and thirty-four percent (149 out of 432) were considered ‘problematic’.
Clinically important information was lost within both classification systems. Most important, the varus/valgus distinction was not found within the Neer classification and a clear definition of displacement was lacking in the AO/OTA classification. We encourage surgeons and researches to report data from both classification systems for a more thorough description of the fracture patterns and to enable cross-checking of the coding. A suitable table for cross-checking of the coding is provided herein.
PMCID: PMC3610277  PMID: 23442552
Proximal humeral fractures; Proximal humerus fractures; Shoulder fractures; Fracture classification; Neer; AO; OTA
6.  Reliability of patient-reported functional outcome in a joint replacement registry 
Acta Orthopaedica  2013;84(1):12-17.
Background and purpose
Patient-reported outcome measures (PROMs) are used by some arthroplasty registries to evaluate results after surgery, but non-response may bias the results. The aim was to identify a potential bias in the outcome scores of subgroups in a cohort of patients from the Danish Shoulder Arthroplasty Registry (DSR) and to characterize non-responders.
Patient-reported outcome of 787 patients operated in 2008 was assessed 12 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder (WOOS) index. In January 2012, non-responders and incomplete responders were sent a postal reminder. Non-responders to the postal reminder were contacted by telephone. Total WOOS score and WOOS subscales were compared for initial responders (n = 509), responders to the postal reminder (n = 156), and responders after telephone contact (n = 27). The predefined variables age, sex, diagnosis, geographical region, and reoperation rate were compared for responding and non-responding cohorts.
A postal reminder increased the response rate from 65% (6% incomplete) to 80% (3% incomplete) and telephone contact resulted in a further increase to 82% (2% incomplete). We did not find any statistically significant differences in total WOOS score or in any of the WOOS subscales between responders to the original questionnaire, responders to the postal reminder, and responders after telephone contact. However, a trend of worse outcome for non-responders was found. The response rate was lower in younger patients.
Non-responders did not appear to bias the overall results after shoulder replacement despite a trend of worse outcome for a subgroup of non-responders. As response rates rose markedly by the use of postal reminders, we recommend the use of reminders in arthroplasty registries using PROMs.
PMCID: PMC3584596  PMID: 23343374
7.  Surgeons agree more on treatment recommendations than on classification of proximal humeral fractures 
Orthopaedic surgeons disagree considerably when classifying fractures of the proximal humerus. However, the clinical implications of low observer agreement remain unclear. The purpose of the study was to compare the agreement on Neer classification with the agreement on treatment recommendations.
We conducted a multi-centre observer-study. Five experienced shoulder surgeons independently assessed a consecutive series of 193 radiographs at two occasions three months apart. All pairs of radiographs were classified according to Neer. Subsequently, the observers were asked to recommend one of three treatment modalities for each case: non-operative treatment, locking plate osteosynthesis, or hemiarthroplasty.
At both classification rounds mean kappa-values for inter-observer agreement on treatment recommendations (0.48 and 0.52) were significantly higher than the agreement on Neer classification (0.33 and 0.36) (p < 0.001 at both rounds). The highest mean kappa-values were found for inter-observer agreement on non-surgical treatment (0.59 and 0.55). In 36% (345 out of 965) of observations an observer changed Neer category between first and second classification round. However, in only 34% of these cases (116 out of 345) the observers changed their treatment recommendations.
We found a significantly higher agreement on treatment recommendations compared to agreement on fracture classification. The low observer agreement on the Neer classification reported in several observer studies may have less clinical importance than previously assumed. However, inter-observer agreement did not exceed moderate levels.
PMCID: PMC3495208  PMID: 22738149
8.  Management of Proximal Humeral Fractures in the Nineteenth Century: An Historical Review of Preradiographic Sources 
The diagnosis and treatment of fractures of the proximal humerus have troubled patients and medical practitioners since antiquity. Preradiographic diagnosis relied on surface anatomy, pain localization, crepitus, and impaired function. During the nineteenth century, a more thorough understanding of the pathoanatomy and pathophysiology of proximal humeral fractures was obtained, and new methods of reduction and bandaging were developed.
I reviewed nineteenth-century principles of (1) diagnosis, (2) classification, (3) reduction, (4) bandaging, and (5) concepts of displacement in fractures of the proximal humerus.
A narrative review of nineteenth-century surgical texts is presented. Sources were identified by searching bibliographic databases, orthopaedic sourcebooks, textbooks in medical history, and a subsequent hand search.
Substantial progress in understanding fractures of the proximal humerus is found in nineteenth-century textbooks. A rational approach to understanding fractures of the proximal humerus was made possible by an appreciation of the underlying functional anatomy and subsequent pathoanatomy. Thus, new principles of diagnosis, pathoanatomic classifications, modified methods of reduction, functional bandaging, and advanced concepts of displacement were proposed, challenging the classic management adhered to for more than 2000 years.
The principles for modern pathoanatomic and pathophysiologic understanding of proximal humeral fractures and the principles for classification, nonsurgical treatment, and bandaging were established in the preradiographic era.
PMCID: PMC3048260  PMID: 21136221
9.  The Danish Shoulder Arthroplasty Registry: clinical outcome and short-term survival of 2,137 primary shoulder replacements 
Acta Orthopaedica  2012;83(2):171-173.
The Danish Shoulder Arthroplasty Registry (DSR) was established in 2004. Data are reported electronically by the surgeons. Patient-reported outcome is collected 10–14 months postoperatively using the Western Ontario osteoarthritis of the shoulder index (WOOS). 2,137 primary shoulder arthroplasties (70% women) were reported to the registry between January 2006 and December 2008. Mean age at surgery was 69 years (SD 12). The most common indications were a displaced proximal humeral fracture (54%) or osteoarthritis (30%). 61% were stemmed hemiarthroplasties, 28% resurfacing hemiarthroplasties, 8% reverse shoulder arthroplasties, and 3% total arthroplasties. Median WOOS was 59% (IQR: 37–82). 5% had been revised by the end of June 2010. The most frequent indications for revision were dislocation or glenoid attrition.
PMCID: PMC3339532  PMID: 22329671
10.  Management of Fractures of the Humerus in Ancient Egypt, Greece, and Rome: An Historical Review 
Fractures of the humerus have challenged medical practitioners since the beginning of recorded medical history. In the earliest known surgical text, The Edwin Smith Papyrus (copied circa 1600 BC), three cases of humeral fractures were described. Reduction by traction followed by bandaging with linen was recommended. In Corpus Hippocraticum (circa 440–340 BC), the maneuver of reduction was fully described: bandages of linen soaked in cerate and oil were applied followed by splinting after a week. In The Alexandrian School of Medicine (third century BC), shoulder dislocations complicated with fractures of the humerus were mentioned and the author discussed whether the dislocation should be reduced before or after the fracture. Celsus (25 BC–AD 50) distinguished shaft fractures from proximal and distal humeral fractures. He described different fracture patterns, including transverse, oblique, and multifragmented fractures. In Late Antiquity, complications from powerful traction or tight bandaging were described by Paul of Aegina (circa AD 625–690). Illustrations from sixteenth and seventeenth century surgical texts are included to show the ancient methods of reduction and bandaging. The richness of written sources points toward a multifaceted approach to the diagnosis, reduction, and bandaging of humeral fracture in Ancient Egypt, Greece, and Rome.
PMCID: PMC2690737  PMID: 19002538
11.  Diagnosing displaced four-part fractures of the proximal humerus: a review of observer studies 
International Orthopaedics  2008;33(2):323-327.
Displaced four-part fractures comprise 2–10 % of all proximal humeral fractures. The optimal treatment is unclear and randomised trials are needed. The conduct and interpretation of such trials is facilitated by a reproducible fracture classification. We aimed at quantifying observer agreement on the classification of displaced four-part fractures according to the Neer system. Published and unpublished data from five observer studies were reviewed. Observers agreed less on displaced four-part fractures than on the overall Neer classification. Mean kappa values for interobserver agreement ranged from 0.16 to 0.48. Specialists agreed slightly more than fellows and residents. Advanced imaging modalities (CT and 3D CT) seemed to contribute more to classification of displaced four-part patterns than in less complex fracture patterns. Low observer agreement may challenge the clinical approach to displaced four-part fractures and poses a problem for the interpretation and generalisation of results from future randomised trials.
PMCID: PMC2899076  PMID: 18536918
12.  Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial 
Trials  2009;10:51.
Fractures of the proximal humerus are common injuries and account for 4–5 percent of all fractures, second only to hip and wrist fractures. The incidence is positively correlated with age and osteoporosis, and is likely to increase. Displaced four-part fractures are among the most severe injuries, accounting for 2–10 percent of proximal humeral fractures. The optimal intervention is disputed. Two previous randomised trials were very small and involved a noticeable risk of bias, and systematic reviews consequently conclude that there is inadequate basis for evidence-based treatment decisions. We aim to compare the effect of osteosynthesis with angle-stable plate with non-surgical management, and the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management.
We will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36).
PMCID: PMC2714035  PMID: 19586546

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