Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial.

BACKGROUND: The incidence of fragility fractures of the pelvis is rising. Whereas the treatment for FFP type I, III, and IV is clear, the optimal treatment for FFP type II remains a topic of discussion. Traditionally these fractures have been treated conservatively. However, there is a shift toward early surgical stabilization with percutaneous screw fixation to reduce pain and promote mobility in an already frail patient population. High-quality evidence, however, is lacking. Therefore, a randomized clinical trial was designed to compare conservative management to early percutaneous screw fixation in patients with type II fragility fractures. METHODS: This is a monocenter randomized controlled trial. All patients with a FFP type II are screened for inclusion. After obtaining informed consent, patients are randomized between conservative management and surgical stabilization. Conservative management consists of early mobilization under guidance of physiotherapy and analgesics. Patients randomized for surgical treatment are operated on within 72 h using percutaneous screw fixation. The primary endpoint is mobility measured by the DEMMI score. Secondary endpoints are other dimensions of mobility, pain levels, quality of life, mortality, and morbidity. The total follow-up is 1 year. The required sample size is 68. DISCUSSION: The present study aims to give certainty on the potential benefit of surgical treatment. Current literature on this topic remains unclear. According to the volume of FFP at the study hospital, we assume that the number of patients needed for this study is gathered within 2 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT04744350. Registered on February 8, 2021.

Minimally invasive plate osteosynthesis (MIPO) for scapular fractures.

OBJECTIVE: Presentation of a minimally invasive surgical approach for the treatment of scapular fractures and the clinical outcome using this technique. INDICATIONS: Displaced extra-articular fractures of the scapula body and glenoid neck (AO 14B and 14F) and simple intra-articular fractures of the glenoid. CONTRAINDICATIONS: Complex intra-articular fractures and isolated fractures of the coracoid base. SURGICAL TECHNIQUE: Make a straight or slightly curved incision along the lateral margin of the scapula leaving the deltoid fascia intact. Identify the interval between the teres minor muscle and infraspinatus to visualize the lateral column, whilst retracting the deltoid to visualize the glenoid neck. Reduce and align the fracture using direct and indirect reduction tools. A second window on the medial border of the scapula can be made to aid reduction and/or to augment stability. Small (2.0-2.7 mm) plates in a 90° configuration on the lateral border and, if required, on the medial border are used. Intra-operative imaging confirms adequate reduction and extra-articular screw placement. POSTOPERATIVE MANAGEMENT: Direct postoperative free functional nonweight-bearing rehabilitation limited to 90° abduction for the first 6 weeks. Sling for comfort. Free range of motion and permissive weight-bearing after 6 weeks. RESULTS: We collected data from 35 patients treated with minimally invasive plate osteosynthesis (MIPO) between 2011 and 2021. Average age was 53 ± 15.1 years (range 21-71 years); 17 had a type B and 18 a type F fracture according the AO classification. All patients suffered concomitant injuries of which thoracic (n = 33) and upper extremity (n = 25) injuries were most common. Double plating of the lateral border (n = 30) was most commonly performed as described in the surgical technique section. One patient underwent an additional osteosynthesis 3 months after initial surgery due to pain and lack of radiological signs of healing of a fracture extension into the spine of the scapula. In the same patient, the plate on the spine of scapula was later removed due to plate irritation. In 2 patients postoperative images showed a screw protruding into the glenohumeral joint requiring revision surgery. After standardisation of intra-operative imaging following these two cases, intra-articular screw placement did not occur anymore. No patient suffered from iatrogenic nerve injury and none developed a wound infection.

Concepts, utilization, and perspectives on the Dutch Nationwide Trauma registry: a position paper.

Over the last decades, the Dutch trauma care have seen major improvements. To assess the performance of the Dutch trauma system, in 2007, the Dutch Nationwide Trauma Registry (DNTR) was established, which developed into rich source of information for quality assessment, quality improvement of the trauma system, and for research purposes. The DNTR is one of the most comprehensive trauma registries in the world as it includes 100% of all trauma patients admitted to the hospital through the emergency department. This inclusive trauma registry has shown its benefit over less inclusive systems; however, it comes with a high workload for high-quality data collection and thus more expenses. The comprehensive prospectively collected data in the DNTR allows multiple types of studies to be performed. Recent changes in legislation allow the DNTR to include the citizen service numbers, which enables new possibilities and eases patient follow-up. However, in order to maximally exploit the possibilities of the DNTR, further development is required, for example, regarding data quality improvement and routine incorporation of health-related quality of life questionnaires. This would improve the quality assessment and scientific output from the DNTR. Finally, the DNTR and all other (European) trauma registries should strive to ensure that the trauma registries are eligible for comparisons between countries and healthcare systems, with the goal to improve trauma patient care worldwide.

Long-term follow-up of patients with displaced scapular fractures managed surgically and non-operatively.

INTRODUCTION: Controversy remains on which patients with displaced scapula fractures benefit from surgery. This retrospective cohort study aims to compare and describe long-term patient-reported outcomes of patients with displaced scapula fractures treated both surgically and conservatively. METHODS: This study included patients with intra- and extra-articular scapula fractures, treated between 2010 and 2020 in a Swiss level 1 trauma centre. The decision to operate was based on standardized criteria for fracture displacement. Patients with isolated Bankart lesions (Ideberg 1) and process fractures (AO type 14-A) were excluded. Primary outcomes were functional patient reported measures (DASH score) and quality of life (EQ5D score). Secondary outcomes were complications, radiological union, satisfaction with treatment, pain and range of motion. RESULTS: Out of 486 cases, 74 patients had displaced scapula fractures. Forty patients were treated surgically and 34 were treated conservatively. Significantly more patients with intra-articular fractures and high-energy trauma were treated surgically. Fifty percent returned the questionnaires after a mean follow-up of 47 months (± SD 36). The mean DASH score of this group was 12 (SD 15.6), with a mean of 14.7 (SD 15.9) in the surgery group and 9.8 (SD 14.6) in the non-operative group (p = 0.7). Multivariate analysis did not show statistically significant correlating factors. No significant differences in quality of life were observed. Patients rated their treatment with a mean of 8.6/10 (SD 1.8). Among surgically treated patients, 19 underwent a deltoid sparing procedure with significant shorter time to union than those that underwent deltoid release (23 vs. 49 weeks, p<0.01). Complications occurred in 3/28 surgically treated patients and all three required a reoperation. CONCLUSION: In this cohort, functional results after conservative and surgical treatment were similar, despite more complex fractures and more intra-articular fractures being treated surgically. Osteosynthesis of both intra- and extra-articular scapula fractures is safe and leads to good functional results, furthermore, new minimal invasive techniques may lead to faster bone healing and return to work and sports.

Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial.

BACKGROUND: The BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) intervention was designed to integrate the approach to chronic disease prevention and screening in primary care and demonstrated effective in a previous randomized trial. METHODS: We tested the effectiveness of the BETTER HEALTH intervention, a public health adaptation of BETTER, at improving participation in chronic disease prevention and screening actions for residents of low-income neighbourhoods in a cluster randomized trial, with ten low-income neighbourhoods in Durham Region Ontario randomized to immediate intervention vs. wait-list. The unit of analysis was the individual, and eligible participants were adults age 40-64 years residing in the neighbourhoods. Public health nurses trained as "prevention practitioners" held one prevention-focused visit with each participant. They provided participants with a tailored prevention prescription and supported them to set health-related goals. The primary outcome was a composite index: the number of evidence-based actions achieved at six months as a proportion of those for which participants were eligible at baseline. RESULTS: Of 126 participants (60 in immediate arm; 66 in wait-list arm), 125 were included in analyses (1 participant withdrew consent). In both arms, participants were eligible for a mean of 8.6 actions at baseline. At follow-up, participants in the immediate intervention arm met 64.5% of actions for which they were eligible versus 42.1% in the wait-list arm (rate ratio 1.53 [95% confidence interval 1.22-1.84]). CONCLUSION: Public health nurses using the BETTER HEALTH intervention led to a higher proportion of identified evidence-based prevention and screening actions achieved at six months for people living with socioeconomic disadvantage. TRIAL REGISTRATION: NCT03052959 , registered February 10, 2017.

Intramedullary screw fixation of metacarpal and phalangeal fractures - A systematic review of 837 patients.

Intramedullary screw (IMS) fixation is increasingly used as an alternative treatment option in metacarpal and phalangeal fractures of the hand. However, this technique is currently the subject of controversy among hand surgeons. The aim of this systematic review was to gain insight on radiological, functional and patient-rated outcomes reported in literature. A comprehensive literature search of PubMed, Embase, CENTRAL and CINAHL databases was conducted on March 1st, 2021. All studies reporting on fracture union, complications, and functional and patient-rated outcome in IMS fixation of metacarpal and/or phalangeal fractures were selected. Two prospective and 16 retrospective cohort studies were included, encompassing a total of 837 patients with 958 fractures (693 metacarpal, 222 proximal phalangeal and 43 middle phalangeal). Mean surgery duration was 26.4 min (range 5-60 min). Union was ultimately achieved in all fractures in a mean of 5.7 weeks (range 2-12 weeks). The procedure-related complication rate was 3.2%. The most frequently reported complication was limitation of joint motion, occurring in 2.0% of cases. Incidence of other complications, including loss of reduction, infection and screw protrusion did not exceed 1%. Overall mean total active motion averaged 243° and grip strength reached 97.5% of the contralateral side. The Disabilities of the Arm, Shoulder and Hand (DASH) score averaged 3.7 points. Duration of sick leave was 7.3 weeks. According to the findings of this systematic review, IMS fixation is a time-saving and safe minimally invasive solution for both metacarpal and phalangeal fractures, with a low rate of complications and promising functional and patient-rated results.

Plate vs. nail for extra-articular distal tibia fractures: How should we personalize surgical treatment? A meta-analysis of 1332 patients.

BACKGROUND: Treatment for distal diaphyseal or metaphyseal tibia fractures is challenging and the optimal surgical strategy remains a matter of debate. The purpose of this study was to compare plate fixation with nailing in terms of operation time, non-union, time-to-union, mal-union, infection, subsequent re-interventions and functional outcomes (quality of life scores, knee- and ankle scores). METHODS: A search was performed in PubMed/Embase/CINAHL/CENTRAL for all study designs comparing plate fixation with intramedullary nailing (IMN). Data were pooled using RevMan and presented as odds ratios (OR), risk difference (RD), weighted mean difference (WMD) or weighted standardized mean difference (WSMD) with a 95% confidence interval (95%CI). All analyzes were stratified for study design. RESULTS: A total of 15 studies with 1332 patients were analyzed, including ten RCTs (n = 873) and five observational studies (n = 459). IMN leads to a shorter time-to-union (WMD: 0.4 months, 95%CI 0.1 - 0.7), shorter time-to-full-weightbearing (WMD: 0.6 months, 95%CI 0.4 - 0.8) and shorter operation duration (WMD: 15.5 min, 95%CI 9.3 - 21.7). Plating leads to a lower risk for mal-union (RD: -10%, OR: 0.4, 95%CI 0.3 - 0.6), but higher risk for infection (RD: 8%, OR: 2.4, 95%CI 1.5 - 3.8). No differences were detected with regard to non-union (RD: 1%, OR: 0.7, 95%CI 0.3 - 1.7), subsequent re-interventions (RD: 4%, OR: 1.3, 95%CI 0.8 - 1.9) and functional outcomes (WSMD: -0.4, 95%CI -0.9 - 0.1). The effect estimates of RCTs and observational studies were equal for all outcomes except for time to union and mal-union. CONCLUSION: Satisfactory results can be obtained with both plate fixation and nailing for distal extra-articular tibia fractures. However, nailing is associated with higher rates of mal-union and anterior knee pain while plate fixation results in an increased risk of infection. This study provides a guideline towards a personalized approach and facilitates shared decision-making in surgical treatment of distal extra-articular tibia fractures. The definitive treatment should be case-based and aligned to patient-specific needs in order to minimize the risk of complications.

[Bone growth stimulators for fractures; sensible or not?] / Botgroeistimulatoren bij fracturen.

More and more patients with fractures are asking for bone growth stimulators. There are currently 2 types of bone growth stimulators on the market: stimulators using pulsed electromagnetic fields (PEMF) and stimulators using low-intensity pulsed ultrasound (LIPUS). There is insufficient evidence that LIPUS bone growth stimulator treatment is useful in patients with fresh fractures; the effects of LIPUS bone growth stimulation for delayed-union and non-union fractures need more in-depth investigation. There is also insufficient evidence that PEMF bone growth stimulation has beneficial effects on the healing of fresh fractures and delayed-union and non-union fractures. We do not recommend routine use of bone growth stimulators, partly because of the significant costs involved.

Results of plate fixation for humerus fractures in a large single-center cohort.

INTRODUCTION: This study aims to describe the results of plate fixation in one of the largest single-center cohorts that employs plate fixation as the golden standard. Additionally, risk factors related to a negative outcome were identified. MATERIALS AND METHODS: This was a retrospective cohort study of all patients treated for a humeral shaft fracture in a level-one trauma center between January 2010 and December 2017 with a mean follow-up of 1 year. RESULTS: Plate fixation was performed in 102 patients with a humeral shaft fracture. The mean age was 50 (SD 20) years with 54.9% (n = 56) being male. Forty-eight percent (n = 48) had an AO type-A, 34.3% (n = 35) type-B, and 18.7% (n = 19) type-C fracture. Deep surgical site infections and non-union occurred in 1% (n = 1) and 3.9% (n = 4) of patients, respectively. Revision of the implant was performed in 15.7% (n = 16) mainly due to implant-related complaints. Only one patient developed radial nerve palsy after surgery. The median duration to radiological fracture healing and full-weight bearing was 18 (range 7-65) weeks and 14 (range 6-56) weeks, respectively. Risk factors for negative outcome included higher age, osteoporosis, open and higher AO class fractures, performing surgery during out-office hours, and the use of LCP 3.5-mm plate and an anterolateral approach. CONCLUSION: Plate fixation for humeral shaft fractures has low risks of complications. It should be emphasized that the complications can be further minimized with a greater surgical expertise and by refraining from performing a surgery during out-office hours.

Inter- and intra-observer variability of the AO/OTA classification for sternal fractures: a validation study.

INTRODUCTION: Recently, a new classification system for sternal fractures has been published in the Journal of Orthopedic trauma by the Arbeitsgemeinschaft für Osteosynthesefragen (AO) foundation and the Orthopaedic Trauma Association (OTA). The aim of this study was to evaluate inter- and intra-observer variability of the AO/OTA classification for sternal fractures. MATERIALS AND METHODS: Twenty multidetector computed tomography (CT) scans of patients with sternal fractures were classified independently by six senior and six junior orthopedic trauma surgeons of two level-1 trauma centers. Assessment was done on two occasions with an interval of 6 weeks. The kappa value was calculated to determine variability. RESULTS: The inter-observer variability of the AO/OTA classification for sternal fractures showed fair-to-moderate agreement (kappa = 0.364). There was no significant difference between junior and senior surgeons. Analyses of the separate components of the classification demonstrated that agreement was lowest for classifying fracture type within the sternal body (kappa = 0.319) followed by manubrium (kappa = 0.525). The intra-observer variability showed moderate agreement with a mean kappa of 0.414. CONCLUSION: The inter- and intra-observer variability of the AO/OTA classification for sternal fractures shows fair-to-moderate agreement. The overall performance of the classification might be improved with minor modifications. LEVEL OF EVIDENCE: Diagnostic cross-sectional study (level I).

Absolute or relative stability in plate fixation for simple humeral shaft fractures.

INTRODUCTION: Minimal invasive plating (MIPO) techniques for humeral shaft fractures appear to have fewer complications and higher union rates compared to open reduction and internal fixation (ORIF). It is questionable if this also applies to simple humeral shaft fractures, as simple fractures are generally treated with absolute stability which cannot be obtained with MIPO. This raises the question whether biology or biomechanics is more important in fracture healing. This study was developed to investigate the biomechanical part of this equation. The aim of the study was to compare relative stability to absolute stability in simple humeral shaft fractures with regard to fracture healing METHODS: This was a retrospective study of all patients treated with plate fixation for AO/OTA type A1-B3 humeral shaft fractures. Patients were categorized into two groups: absolute stability and relative stability. Both groups were compared with regard to time to radiological union and full weight bearing RESULTS: Thirty patients were included in the relative-stability-group with either an AO/OTA type A (n = 18) or type B (n = 12) humeral shaft fracture and a mean age of 55 (SD 21) years. A total of 46 patients were included in the absolute-stability-group: 27 patients had a type A and 19 type B fracture. The mean age in this group was 45 (SD 19) years. Median follow-up was 12 months (IQR 8-13). Minimally invasive approach was used in 15 (50%) patients in the relative stability group. Time to radiological union was significantly shorter in the absolute-stability-group with a median of 14 (IQR 12-22) versus 25 (IQR17-36) weeks and HR 2.60 (CI 1.54-4.41)(p < 0.001). This difference remained significant after correction for type of approach (adjusted HR 3.53 CI 1.72-7.21) (p 0.001). There was no significant difference in time to full weight bearing. The addition of lag screws in the absolute stability group did not influence time to radiological healing or full weight bearing. CONCLUSION: Absolute stability for simple humeral shaft fractures leads to a significantly shorter time to radiological union compared to relative stability. The addition of lag screws to gain interfragmentary compression does not reduce fracture healing time.

Cost-effectiveness analysis of a multicentre randomized clinical trial comparing surgery with conservative management for recurrent and ongoing diverticulitis (DIRECT trial).

BACKGROUND: The results of the DIRECT trial, an RCT comparing conservative management with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints, showed that elective sigmoid resection leads to higher quality of life. The aim of this study is to determine the cost-effectiveness of surgical treatment at 1- and 5-year follow-up from a societal perspective. METHODS: Clinical effectiveness and resource use were derived from the DIRECT trial. The actual resource use and quality of life (EQ-5D-3L™ score) were documented prospectively per individual patient and analysed according to the intention-to-treat principle for up to 5 years after randomization. The main outcome was the incremental cost-effectiveness ratio (ICER), expressed as costs per quality-adjusted life-year (QALY). RESULTS: The study included 106 patients, of whom 50 were randomized to surgery and 56 to conservative treatment. At 1- and 5-year follow-up an incremental effect (QALY difference between groups) of 0·06 and 0·43 respectively was found, and an incremental cost (cost difference between groups) of €6957 and €2674 respectively, where surgery was more expensive than conservative treatment. This resulted in an ICER of €123 365 per additional QALY at 1-year follow-up, and €6275 at 5 years. At a threshold of €20 000 per QALY, operative treatment has 0 per cent probability of being cost-effective at 1-year follow-up, but a 95 per cent probability at 5 years. CONCLUSION: At 5-year follow-up, elective sigmoid resection in patients with recurring diverticulitis or persistent complaints was found to be cost-effective. Registration number: NTR1478 (www.trialregistrer.nl).

Risk factors for complicated diverticulitis: systematic review and meta-analysis.

PURPOSE: The aim of this systematic review is to identify risk factors that can predict complicated diverticulitis. Uncomplicated diverticulitis is a self-limiting and mild disease, but 10% of patients with diverticulitis develop complications requiring further treatment. It is important to estimate the risk of developing complicated diverticulitis at an early stage to set the right treatment at initial presentation. METHODS: Embase, MEDLINE, and Cochrane databases were searched for studies reporting on risk factors for complicated diverticulitis. Complicated diverticulitis was defined as Hinchey ≥Ib or severe diverticulitis according to the Ambrosetti criteria. Meta-analyses were performed when at least four studies reported on the outcome of interest. This study was conducted according to the PRISMA guidelines. RESULTS: A total of 12 studies were included with a total of 4619 patients. Most were of reasonable quality. Only the risk factors "age" and "sex" were eligible for meta-analysis, but none showed a significant effect on the risk for complicated diverticulitis. There was reasonable quality of evidence suggesting that high C-reactive protein; white blood cell count; clinical signs including generalized abdominal pain, constipation and vomiting; steroid usage; a primary episode; and comorbidity are risk factors for complicated diverticulitis. CONCLUSION: Although high-level evidence is lacking, this study identified several risk factors associated with complicated diverticulitis. Individually, these risk factors have little value in predicting the course of diverticulitis. The authors propose a prognostic model combining these risk factors which might be the next step to aid the physician in predicting the course of diverticulitis and setting the right treatment at initial presentation.