Amar Rangan

Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial

IMPORTANCEnThe need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing.nnnOBJECTIVEnTo evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck.nnnDESIGN, SETTING, AND PARTICIPANTSnA pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis.nnnINTERVENTIONSnFracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups.nnnMAIN OUTCOMES AND MEASURESnPrimary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality.nnnRESULTSnThere was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; Pu2009=u2009.48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; Pu2009=u2009.18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; Pu2009=u2009.32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; Pu2009=u2009.28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; Pu2009=u2009.58); and mortality (9 patients vs 5 patients; Pu2009=u2009.27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay.nnnCONCLUSIONS AND RELEVANCEnAmong patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus.nnnTRIAL REGISTRATIONnisrctn.com Identifier: ISRCTN50850043.

The effectiveness of interventions in the management of patients with primary frozen shoulder

There are many types of treatment used to manage the frozen shoulder, but there is no consensus on how best to manage patients with this painful and debilitating condition. We conducted a review of the evidence of the effectiveness of interventions used to manage primary frozen shoulder using the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Physiotherapy Evidence Database, MEDLINE and EMBASE without language or date restrictions up to April 2009. Two authors independently applied selection criteria and assessed the quality of systematic reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Data were synthesised narratively, with emphasis placed on assessing the quality of evidence. In total, 758 titles and abstracts were identified and screened, which resulted in the inclusion of 11 systematic reviews. Although these met most of the AMSTAR quality criteria, there was insufficient evidence to draw firm conclusions about the effectiveness of treatments commonly used to manage a frozen shoulder. This was mostly due to poor methodological quality and small sample size in primary studies included in the reviews. We found no reviews evaluating surgical interventions. More rigorous randomised trials are needed to evaluate the treatments used for frozen shoulder.

Cemented versus cementless hemiarthroplasty for intracapsular neck of femur fracture—A comparison of 60,848 matched patients using national data

National guidelines recommend cemented hemiarthroplasty for intracapsular fractured neck of femur (NOF), based on evidence of less pain, better mobility and lower costs. We aimed to compare complications following cemented and cementless implants, using the national hospital episode statistics (HES) database in England. Dislocation, revision, return to theatre and medical complications were extracted for all patients with NOF fracture who underwent hemiarthroplasty between January 2005 and December 2008. To make a like for like comparison all 30,424 patients with a cementless implant were matched to 30,424 cemented implants (from a total of 42,838) in terms of age, sex and Charlson co-morbidity score. In the cementless group, 18-month revision (1.62% versus 0.57% (OR 2.90, p<0.001)), 4-year revision (2.45% versus 1.11% (OR 2.28, p<0.001)) and 30-day chest infection (8.14% versus 7.23% (OR 1.14, p=0.028)) were significantly higher. Four-year dislocation rate was higher in cemented implants (0.60% versus 0.26% (OR 0.45, p<0.001)). No significant differences were seen in return to theatre or other medical complications. In this national analysis of matched patients mid-term revision and perioperative chest infection was significantly higher in the cementless group. This supports the published evidence and national guidelines recommending cement fixation of hemiarthroplasty.

Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: analysis from the DRAFFT trial.

We present an economic evaluation using data from the Distal Radius Acute Fracture Fixation Trial (DRAFFT) to compare the relative cost effectiveness of percutaneous Kirschner wire (K-wire) fixation and volar locking-plate fixation for patients with dorsally-displaced fractures of the distal radius. The cost effectiveness analysis (cost per quality-adjusted life year; QALY) was derived from a multi-centre, two-arm, parallel group, assessor-blind, randomised controlled trial which took place in 18 trauma centres in the United Kingdom. Data from 460 patients were available for analysis, which includes both a National Health Service cost perspective including costs of surgery, implants and healthcare resource use over a 12-month period after surgery, and a societal perspective, which includes the cost of time off work and the need for additional private care. There was only a small difference in QALYs gained for patients treated with locking-plate fixation over those treated with K-wires. At a mean additional cost of £714 (95% confidence interval 588 to 865) per patient, locking-plate fixation presented an incremental cost effectiveness ratio (ICER) of £89,322 per QALY within the first 12 months of treatment. Sensitivity analyses were undertaken to assess the ICER of locking-plate fixation compared with K-wires. These were greater than £30,000. Compared with locking-plate fixation, K-wire fixation is a cost saving intervention, with similar health benefits.

Managing Idiopathic Frozen Shoulder: A Survey of Health Professionals' Current Practice and Research Priorities

Background We aimed to identify the treatments used by health care professionals in current practice for the management of patients with idiopathic frozen shoulder and the need for further research in this area, specifically a randomized trial. Methods Three hundred and three health care professionals (i.e. general practitioners, physiotherapists and orthopaedic surgeons) completed an online survey about idiopathic frozen shoulder management and research priorities. The results were analyzed using descriptive statistics, chi-square statistics and thematic analysis of qualitative data. Results Conservative treatment and physical therapy were identified as the most common interventions for treating patients presenting with frozen shoulder in the early ‘painful’ phase. Approximately half of the respondents would recommend surgery for patients with ‘resolution’ phase frozen shoulder, although there was some disagreement about the role of pain as an indicator for surgery. Most respondents (221/251) considered that more research was needed using a randomized trial design, in particular aiming to investigate the effectiveness of physical therapy and surgery. Conclusion Health professionals manage frozen shoulders differently for different phases of the condition. More research is needed to compare different interventions for the management of patients with idiopathic frozen shoulder.

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

BACKGROUNDnProximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck.nnnOBJECTIVEnTo evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults.nnnDESIGNnA pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years.nnnSETTINGnRecruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation.nnnPARTICIPANTSnAdults (aged ≥u200916 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck.nnnINTERVENTIONSnThe choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups.nnnMAIN OUTCOME MEASURESnThe primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected.nnnRESULTSnThe mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; pu2009=u20090.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing <u2009£20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses.nnnCONCLUSIONSnCurrent surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care.nnnTRIAL REGISTRATIONnCurrent Controlled Trials ISRCTN50850043.nnnFUNDINGnThis project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Cemented hemiarthroplasty or hip replacement for intracapsular neck of femur fracture? A comparison of 7732 matched patients using national data

BACKGROUNDnThe treatment of choice for intracapsular neck of femur (NOF) fractures in younger, more active patients remains unknown. Some surgeons advocate total hip replacement (THR).nnnAIMnThis study aimed to compare complications following THR and hemiarthroplasty using the Hospital Episode Statistics (HES) database in England.nnnMETHODnDislocation and revision rates were extracted for all patients with NOF fracture who underwent either cemented hemiarthroplasty or cemented THR between January 2005 and December 2008. To make a like for like comparison all 3866 THR patients were matched to 3866 hemiarthroplasty patients (from a total of 41,343) in terms of age, sex and Charlson score.nnnRESULTS AND CONCLUSIONnEighteen-month dislocation was significantly higher in the THR group (2.4% vs. 0.5%, odds ratio (OR) 3.90 (2.99-5.05), p<0.001). This difference was sustained at the 4-year stage (2.9% vs. 0.9%, OR 3.18 (1.58-6.94), p=0.001) in a subset of patients with longer follow-up. There was no significant difference in revision rate up to 4 years (1.8% vs. 2.1%, OR 0.85 (0.46-1.55), p=0.666). In this national analysis of matched patients short- and medium-term dislocation rates following THR were significantly higher than following cemented hemiarthroplasty, without any difference in revision rates at 4 years. The low risk of dislocation may be acceptable in order to experience the apparent functional benefits of THR.

Pulmonary embolism following ankle fractures treated without an operation - An analysis using National Health Service data

The majority of ankle fractures are stable and can be treated without an operation, most commonly with cast immobilisation. Based on concerns regarding the risk of a venous thromboembolic event (VTE) while immobilised, there is currently debate as to whether these patients should receive VTE prophylaxis for the duration of treatment. Rates of pulmonary embolism (PE) in this patient group are unknown. This retrospective cohort study was designed to identify patients treated without an operation for ankle fracture and determine the occurrence of PE and inpatient mortality within 90 days of injury using the English National Health Service administrative databases. Logistic regression models were used to assess the influence of age, gender and Charlson co-morbidity score on these outcomes. We identified 14777 adult patients over a 54-month period (April 2007-September 2011) that met our linkage and inclusion criteria (isolated, unilateral closed ankle fracture that did not require hospitalisation). Mean age was 46.4 years (range 18-99) and the majority had a Charlson 0 score (97.7%). There were 32 (0.22%) PEs within 90 days of the fracture (including in one patient who subsequently died). After adjustment, Charlson score of ≥1 was associated with a greater risk of PE (Odds ratio = 11.97, p < 0.001) compared to Charlson 0. Risk for these patients was 2.08%. In total, fifteen patients (0.11%) died in hospital within 90 days. Pulmonary embolism is rare following ankle fractures treated without an operation. Patients with multiple co-morbidities are at a higher risk. Based on this evidence, an ankle fracture treated without an operation does not appear to be an indication for routine VTE prophylaxis.

A case of postpartum pubic symphysis diastasis

The symphysis pubis is a secondary cartilaginous joint and in response to hormonal changes during pregnancy (especially the 3rd trimester), the joint widens to increase the saggital diameter of the outlet. Mild separation of the pubic symphysis is therefore considered necessary for childbirth, with an average normal radiological distance between pubic bodies of 4 mmwidening by a further 3 mm during pregnancy. A widening of 10 mm has been defined as the upper limit of physiological separation. Pubic symphysis diastasis is a recognised rare complication of pregnancy, with a variable reported incidence of 1 in 300 to 1 in 30,000 deliveries. Separation of over 1 cm can rarely occur, and is often symptomatic, leading to pain at delivery and during the postpartum period. We present a case of spontaneous symphysis pubis diastasis in a healthy primigravida, after a vaginal delivery.

Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus

Aims The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non‐operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long‐term treatment effects beyond the two‐year follow‐up. Patients and Methods Of the original 250 trial participants, 176 consented to extended follow‐up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D‐3L (EQ‐5D‐3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. Results OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non‐operative treatment at each follow‐up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ‐5D‐3L data showed no significant between‐group differences in quality of life over time. Conclusion These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years.