Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Distal radius fractures are common and are managed with or without surgery. Current evidence indicates surgical treatment is not superior to nonsurgical treatment at 12 months. Objective: Does surgical treatment for displaced distal radius fractures in patients 60 years or older provide better patient-reported wrist pain and function outcomes than nonsurgical treatment at 24 months? Design, Setting, and Participants: In this secondary analysis of a combined multicenter randomized clinical trial (RCT) and a parallel observational study, 300 patients were screened from 19 centers in Australia and New Zealand. Of these, 166 participants were randomized to surgical or nonsurgical treatment. Participants who declined randomization (n = 134) were included in the parallel observational group with the same treatment options and follow-up. Participants were followed up at 3, 12, and 24 months by a blinded assessor. The 24-month outcomes are reported herein. Data were collected from December 1, 2016, to December 31, 2020, and analyzed from February 4 to October 21, 2021. Interventions: Surgical treatment consisting of open reduction and internal fixation using a volar-locking plate (VLP group) and nonsurgical treatment consisting of closed reduction and cast immobilization (CR group). Main Outcomes and Measures: The primary outcome was patient-reported function using the Patient-Rated Wrist Evaluation (PRWE) questionnaire. Secondary outcomes included health-related quality of life, wrist pain, patient-reported treatment success, patient-rated bother with appearance, and posttreatment complications. Results: Among the 166 randomized and 134 observational participants (300 participants; mean [SD] age, 71.2 [7.5] years; 269 women [89.7%]), 151 (91.0%) randomized and 118 (88.1%) observational participants were followed up at 24 months. In the RCT, no clinically important difference occurred in mean PRWE scores at 24 months (13.6 [95% CI, 9.1-18.1] points for VLP fixation vs 15.8 [95% CI, 11.3-20.2] points for CR; mean difference, 2.1 [95% CI, -4.2 to 8.5]; P = .50). There were no between-group differences in all other outcomes except for patient-reported treatment success, which favored VLP fixation (33 of 74 [44.6%] in the CR group vs 54 of 72 [75.0%] in the VLP fixation group reported very successful treatment; P = .002). Rates of posttreatment complications were generally low and similar between treatment groups, including deep infection (1 of 76 [1.3%] in the CR group vs 0 of 75 in the VLP fixation group) and complex regional pain syndrome (2 of 76 [2.6%] in the CR group vs 1 of 75 [1.3%] in the VLP fixation group). The 24-month trial outcomes were consistent with 12-month outcomes and with outcomes from the observational group. Conclusions and Relevance: Consistent with previous reports, these findings suggest that VLP fixation may not be superior to CR for displaced distal radius fractures for patient-rated wrist function in persons 60 years or older during a 2-year period. Significantly higher patient-reported treatment success at 2 years in the VLP group may be attributable to other treatment outcomes not captured in this study. Trial Registration: ANZCTR.org Identifier: ACTRN12616000969460.

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial.

Importance: The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence. Objective: To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older. Design, Setting, and Participants: In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses. Intervention: Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR). Main Outcomes and Measures: The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use. Results: In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI -5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02). Conclusions and Relevance: This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people. Trial Registration: http://anzctr.org.au identifier: ACTRN12616000969460.

Ultraprocessed food and chronic noncommunicable diseases: A systematic review and meta-analysis of 43 observational studies.

This systematic review and meta-analysis investigated the association between consumption of ultraprocessed food and noncommunicable disease risk, morbidity and mortality. Forty-three observational studies were included (N = 891,723): 21 cross-sectional, 19 prospective, two case-control and one conducted both a prospective and cross-sectional analysis. Meta-analysis demonstrated consumption of ultraprocessed food was associated with increased risk of overweight (odds ratio: 1.36; 95% confidence interval [CI], 1.23-1.51; P < 0.001), obesity (odds ratio: 1.51; 95% CI, 1.34-1.70; P < 0.001), abdominal obesity (odds ratio: 1.49; 95% CI, 1.34-1.66; P < 0.0001), all-cause mortality (hazard ratio: 1.28; 95% CI, 1.11-1.48; P = 0.001), metabolic syndrome (odds ratio: 1.81; 95% CI, 1.12-2.93; P = 0.015) and depression in adults (hazard ratio: 1.22; 95% CI, 1.16-1.28, P < 0.001) as well as wheezing (odds ratio: 1.40; 95% CI, 1.27-1.55; P < 0.001) but not asthma in adolescents (odds ratio: 1.20; 95% CI, 0.99-1.46; P = 0.065). In addition, consumption of ultraprocessed food was associated with cardiometabolic diseases, frailty, irritable bowel syndrome, functional dyspepsia and cancer (breast and overall) in adults while also being associated with metabolic syndrome in adolescents and dyslipidaemia in children. Although links between ultraprocessed food consumption and some intermediate risk factors in adults were also highlighted, further studies are required to more clearly define associations in children and adolescents. STUDY REGISTRATION: Prospero ID: CRD42020176752.

Transcriptomic analysis of adhesive capsulitis of the shoulder.

Adhesive capsulitis (AC) is a disabling condition of the shoulder joint affecting 2 to 5% of the general population. Our understanding of the molecular mechanisms is limited. The present study aimed to determine potential biomarkers of AC through transcriptomic analysis. This multi-centre study investigated patients undergoing arthroscopic capsulotomy surgery for resistant AC compared to those undergoing arthroscopic stabilization surgery for glenohumeral instability (control). Tissue samples were harvested from the anterior capsule during surgery. Total RNA was extracted and RNA-sequencing-based transcriptomics were performed. A number of genes deemed differentially expressed in RNA-sequencing analysis were validated using real-time reverse transcription polymerase chain reaction (RT-PCR). Baseline characteristics of the AC group (n = 22) were; mean age 52.7 years (SD: 10.2), 73% female, and Oxford Shoulder Score 19.6 (SD: 8.0), compared with the control group (n = 26), average age 23.9 years (SD: 5.2), 15% female, and Oxford Shoulder Score 39.0 (SD: 7.4). Transcriptomic analysis with false discovery rate correction and log2 fold change cut-off of ±1.5 revealed 545 differentially expressed genes in AC relative to control. Bioinformatic analyses were carried out to identify biological processes and pathways enriched in this dataset. Real-time RT-PCR using two different normalization processes confirmed increased expression of matrix metallopeptidase 13 (MMP13) and platelet-derived growth factor subunit B (PDGFB), in patients with AC, while tumor necrosis factor α (TNFA) expression was reduced. These findings provide a comprehensive assessment of transcriptional changes associated with AC that give insights into the aetiology of the disease and provides a resource for molecular targets to better diagnose and treat this condition.

Simultaneous (two-surgeon) versus staged bilateral knee arthroplasty: an observational study of intraoperative and post-operative outcomes.

BACKGROUND: The advantages of simultaneous bilateral total knee arthroplasty (sim-BTKA) remain controversial. This study investigated the effects of two-surgeon sim-BTKA compared to separate admission staged BTKA regarding intraoperative and post-operative outcomes and health service costs. METHODS: Patients underwent sim-BTKA or staged BTKA between 1 November 2008 and 30 June 2016. Data were extracted from a joint replacement registry and medical records. Median regression and chi-squared tests were used for between-group comparisons. RESULTS: Median hospital total length of stay was 5 days less for sim-BTKA (n = 122) than staged BTKA group (n = 46) (7 versus 12; 95% confidence interval (CI) 3.9, 6.1), and 9 days less for inpatient rehabilitation (17 versus 26; 95% CI 3.7, 14.3). However, 80% of sim-BTKA patients went to inpatient rehabilitation (versus 27% following staged BTKA), so median total length of stay was 9 days less for staged BTKA (13 versus 22; 95% CI -12.8, -5.2). Total anaesthesia time was 135 min less for sim-BTKA (P < 0.001), while staged BTKA required less blood transfusions (P = 0.001). Complication rates were similar, except for superficial infections which were observed twice as often after staged BTKA (30% versus 15%, P = 0.048). Twelve months following sim-BTKA and the first staged total knee arthroplasty, sim-BTKA had better WOMAC pain, stiffness and function scores (P ≤ 0.05). Average inpatient costs (hospital and rehabilitation) were $6388 less for sim-BTKA. CONCLUSION: Sim-BTKA appears to be a comparatively safe alternative to staged BTKA. Sim-BTKA may be superior to staged BTKA due to faster improvements in pain and function and lower healthcare costs. How these results generalize to other health services requires further investigation.

Adhesive capsulitis of the shoulder: protocol for the adhesive capsulitis biomarker (AdCaB) study.

BACKGROUND: Adhesive capsulitis (AC) is a disabling and poorly understood pathological condition of the shoulder joint. The current study aims to increase our understanding of the pathogenesis, diagnosis and clinical outcomes of people with AC by investigating: 1) transcriptome-wide alterations in gene expression of the glenohumeral joint capsule in people with AC compared to people with non-inflammatory shoulder instability (controls); 2) serum and urine biomarkers to better understand diagnosis and staging of AC; and 3) clinical outcomes in people with AC compared to controls 12-months following arthroscopic capsular release or labral repair respectively. METHODS: The study is a prospective multi-centre longitudinal study investigating people undergoing arthroscopic capsulotomy for AC compared to people undergoing arthroscopic stabilization for shoulder instability. Tissue samples collected from the anterior glenohumeral joint capsule during surgery will undergo RNA-seq to determine differences in gene expression between the study groups. Gene Set Enrichment Analysis will be used to further understand the pathogenesis of AC as well as guide serum and urine biomarker analysis. Clinical outcomes regarding pain, function and quality of life will be assessed using the Oxford Shoulder Score, Oxford Shoulder Instability Score, Quick DASH, American Shoulder and Elbow Society Score, EQ-5D-5 L and active shoulder range of movement. Clinical outcomes will be collected pre-operatively and 12-months post-operatively and study groups will be compared for statistically significant differences using linear regression, adjusting for baseline demographic variables. DISCUSSION: This study will provide much needed information regarding the pathogenesis, diagnosis and staging of AC. It will evaluate clinical outcomes for people undergoing arthroscopic release of AC by comparing this group to people undergoing arthroscopic surgery for shoulder instability. TRIAL REGISTRATION: ACTRN12618000431224 , retrospectively registered 26 March 2018.

Protocol for a single-centre, parallel-arm, double-blind randomised trial evaluating the effects of tourniquet use in total knee arthroplasty on intra-operative and post-operative outcomes.

BACKGROUND: Tourniquet use during total knee replacement is common, yet uncertainty exists regarding its benefits and harms. The primary aim of the current study is to investigate whether tourniquet use during total knee replacement leads to greater reduction in quadriceps strength than non-tourniquet use at three months post-surgery. Secondary aims include investigating the effects of tourniquet use on: quadriceps strength at day 2 and 5, and 12 months post-surgery; pain and analgesia requirements; self-reported physical function and quality of life; blood loss and replacement; surgeon satisfaction with the intra-operative visual field; operation and anaesthetic time; complications; cement mantle quality; patient satisfaction; and hospital length of stay. METHODS: The study is a single centre, parallel-arm, double-blind (participant and assessor), randomised trial with 1:1 random allocation. Participants will be undergo total knee replacement with or without tourniquet. Linear mixed models will be used for group comparisons of continuous outcomes available at multiple timepoints. Other continuous outcomes that are assessed at baseline and once/twice at follow-up will be analysed using linear regression. Categorical outcomes will be analysed using logistic regression models. DISCUSSION: This study will provide high-quality evidence regarding the effects of tourniquet use during total knee replacement, which can be used to inform surgeon decision-making. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000425291 . Retrospectively registered 23 March 2018.

Identifying complications requiring re-operation following primary hip or knee arthroplasty: a consecutive series of 98 patients.

BACKGROUND: The number of hip and knee arthroplasties completed is expected to double over the next decade. In public hospitals, regular post-arthroplasty orthopaedic review has commonly occurred for the duration of a patient's life, which requires substantial outpatient resources. However, there is limited evidence regarding the utility of these reviews for identifying complications. The current study investigated when and where complications requiring re-operation were identified following primary hip or knee arthroplasty. METHODS: The medical records of all patients requiring re-operation for complications following primary hip arthroplasty (n = 48, 2004 to 2015) or knee primary arthroplasty (n = 50, 1998 to 2015) at a large regional health service were evaluated. Data were extracted by one of four investigators using a standardised electronic data extraction tool. Variables of interest included the health setting where the complication was initially identified, how long following the original operation the complication was identified and whether the complication was symptomatic. RESULTS: Routine post-arthroplasty orthopaedic appointments identified 15 (15.3%) complications requiring re-operation; all were identified in the first-year post-surgery. For each complication identified in the first-year post-surgery, approximately 1000 orthopaedic outpatient appointments were required. After the first year, all complications were identified in Emergency Departments (n = 30, 30.6%), General Practice (n = 24, 24.5%) or non-routine orthopaedic outpatient appointments (n = 19, 19.4%). All patients with complications reported symptoms. CONCLUSIONS: Routine post-arthroplasty review appointments were an inefficient mechanism for identifying complications requiring re-operation more than one year following surgery. Public health services should consider assessing and redesigning post-arthroplasty review services to reduce the burden on patients and the demand for outpatient appointments.

Prospective randomized controlled trial comparing dynamic hip screw and screw fixation for undisplaced subcapital hip fractures.

BACKGROUND: Neck of femur fractures (NOFFs) are a common cause of morbidity and mortality in our community. Minimally displaced intracapsular fractures are treated with internal fixation by a two-hole dynamic hip screw (DHS) or three partially threaded cancellous screws. Data to support the superiority of one are limited. This prospective randomized controlled trial compares outcomes with these two fixation methods. METHODS: We prospectively recruited patients over 50 years, with an acute fracture subcapital NOFF, who walked and lived independently, and were cognitively intact. They were randomized into DHS or cancellous screw groups and followed up for 2 years (overall 75.9%). Outcomes of mortality, revision, loss of fixation, avascular necrosis, surgical complications, WOMAC, Harris hip score and SF-12 were measured. RESULTS: We recruited 62 patients (31 DHS, 29 cancellous screws, 2 failed consent). Six deaths (19.3%) were seen in each group. A total of 3.2% of DHS (1 out of 31) and 10.3% (3 out of 29) of cancellous screw patients required re-operation (P = 0.272). There was no statistical significant difference in patient satisfaction, quality of life (QoL), radiological union or osteonecrosis. There are trends towards better functional scores and QoL in cancellous screws, particularly at 1 year (P = 0.0061), but with a higher re-operation rate. There was a combined mortality and transition to institutional care of 40.0% (24 out of 60) at 2 years. CONCLUSIONS: This study found no difference in outcomes between DHS and cancellous screws in the treatment of subcapital NOFFs in a fit, independent population, but we found a high level of physical decline in previously fit, independently ambulating patients. A large, multicentre trial will be required to differentiate between these two fixation methods.