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Operative treatment of displaced midshaft clavicle fractures: has randomised control trial evidence changed practice patterns?

ABSTRACT: OBJECTIVES:To determine if level 1 evidence from a landmark trial changed practice patterns for treatment of patients with displaced midshaft clavicle fractures. DESIGN:Retrospective cohort study. SETTING:Two level 1 trauma centres. PARTICIPANTS:Displaced midshaft clavicle fractures. RESULTS:686 patients met inclusion criteria. The pretrial cohort (n=108) was 68.5% male, with a mean age of 37.7 (±13.9) years. The post-trial cohort (n=578) was 76.1% male, with a mean age of 41.9 (±12.7) years. There was nearly a 10-fold increase in the patients treated with openreduction and internal fixation (ORIF) in the post-trial cohort (34.1%) compared with the pretrial cohort (3.7%) (p<0.001). Patients in the post-trial cohort were more likely to undergo ORIF if they were <40 years (OR=2.2; 95% CI 1.53 to 3.10), if their Injury Severity Score was >9 (OR=1.6; 95% CI 0.89 to 2.99) or if they were treated at a centre that participated in the Canadian Orthopaedic Trauma Society ( COTS ) trial (OR=5.2; 95% CI 3.31 to 8.21). CONCLUSIONS:This study demonstrated a significant shift towards more frequent ORIF for displaced midshaft clavicle fractures following the COTS trial. Quantifying changes in practice pattern following publication of level 1 evidence is important to further our understanding of the impact large randomised clinical trails are having on clinical practice.

SUBMITTER: Schneider P

PROVIDER: S-EPMC6731861 | biostudies-other | 2019 Sep

REPOSITORIES: biostudies-other

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Operative treatment of displaced midshaft clavicle fractures: has randomised control trial evidence changed practice patterns?

Schneider Prism P Bransford Richard R Harvey Edward E Agel Julie J

BMJ open 20190904 9

<h4>Objectives</h4>To determine if level 1 evidence from a landmark trial changed practice patterns for treatment of patients with displaced midshaft clavicle fractures.<h4>Design</h4>Retrospective cohort study.<h4>Setting</h4>Two level 1 trauma centres.<h4>Participants</h4>Displaced midshaft clavicle fractures.<h4>Results</h4>686 patients met inclusion criteria. The pretrial cohort (n=108) was 68.5% male, with a mean age of 37.7 (±13.9) years. The post-trial cohort (n=578) was 76.1% male, with ...[more]

PMID: 31488493

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Project description:IntroductionFractures of the diaphysis of the clavicle are common; however, treatment guidelines for this condition are lacking. Surgery is associated with a lower risk of non-union and better functional outcomes but a higher risk of complications. Open reduction and internal fixation with plates and screws are the most commonly performed techniques, but they are associated with paraesthesia in the areas of incisions, extensive surgical exposure and high rates of implant removal. Minimally invasive techniques for treating these fractures have a lower rate of complications. The aim of this study is to evaluate which surgical treatment option (minimally invasive osteosynthesis or open reduction and internal fixation) has better prognosis in terms of complications and reoperations.Methods and analysisThe study proposed is a multicentric, pragmatic, randomised, open-label, superiority clinical trial between minimally invasive osteosynthesis and open reduction and internal fixation for surgical treatment of patients with displaced fractures of the clavicle shaft. In the proposed study, 190 individuals with displaced midshaft clavicle fractures, who require surgery as treatment, will be randomised. The assessment will occur at 2, 6, 12, 24 and 48 weeks, respectively. The primary outcome of the study will be the number of complications and reoperations. For sample size calculation, a moderate effective size between the techniques was considered in a two-tailed test, with 95% confidence and 90% power. Complications include cases of infection, hypertrophic scarring, non-union, refracture, implant failure, hypoesthesia, skin irritation and shoulder pain. Reoperations are defined as the number of surgeries for pseudoarthrosis, implant failure, infection and elective removal of the implant.Ethics and disseminationStudy approved by the institutional ethics committee (number 34249120.9.0000.5505-V.3). The results will be disseminated by publications in peer-reviewed journals and presentations in medical meetings.Trial registration numberRBR-3czz68)/UTN U1111-1257-8953.

Project description:IntroductionMidshaft clavicular fractures are common amongst young adults. Conservative or surgical treatment for definitive fracture management has been widely debate, both with their pros and cons. Previous meta-analyses compared the clinical outcomes between conservative and surgical treatment options of midshaft clavicular fractures but failed to elucidate any difference in functional improvement. We postulate that functional improvement after fracture union plateaus and the clinical outcome after treatment varies at different time points. This meta-analysis will focus on the synthesis comparison of outcomes at early, short-term results (3 months), intermediate-term (6 to 12 months) and long-term (>24 months) clinical outcomes.MethodsA systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) in June 2021. Search keywords were: midshaft clavicular fractures and clinical trials. Clinical trials fulfilling the inclusion criteria were selected for comparison and the clinical outcomes of midshaft clavicular fractures using surgical and non-surgical interventions in terms of improvement in the Disabilities of the Arm, Shoulder and Hand (DASH) score, Constant-Murley Score (CMS), time to union and risk ratio of treatment related complications were analysed in correlation with post-treatment timeframe.ResultsOf the 3094 patients of mean age 36.7 years in the 31 selected studies, surgical intervention was associated with improved DASH score (standard-mean difference SMD -0.22, 95% CI -0.36 to -0.07, p = 0.003; mean difference MD -1.72, 95% CI -2.93 to -0.51, p = 0.005), CMS (SMD 0.44, 95% CI 0.17-0.72, p = 0.001; MD 3.64, 95% CI 1.09 to 6.19, p = 0.005), time to union (non-adjusted SMD -2.83, 95% CI -4.59 to -1.07, p = 0.002; adjusted SMD -0.69, 95% CI -0.97 to -0.41, p<0.001) and risk ratio of bone-related complications including bone non-union, malunion and implant failure (0.21, 95% CI 0.1 to 0.42; p<0.001). Subgroup analysis based on time period after treatment showed that surgical intervention was far superior in terms of improved DASH score at the intermediate-term results (6-12 months later, SMD -0.16, 95% CI -0.30 to -0.02, p = 0.02; and long term results (>24 months SMD -4.24, 95% CI -7.03 to -1.45, p = 0.003) and CMS (>24 months, SMD 1.03, 95% CI 0.39 to 1.68, p = 0.002; MD 5.77, 95% CI 1.63 to 9.91, p = 0.006). Surgical outcome is independent of fixation with plates or intra-medullary nails.ConclusionSurgical intervention was associated with better clinical outcomes compared with non-surgical approach for midshaft clavicular fractures in terms of improvement in functional scores DASH, CMS, time to union and fracture related complications, although not to the minimal clinically significant difference. Benefits in the long-term functional improvements are more pronounced.

Project description:BackgroundThere are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fractures of the ankle. Conservative management could result in fewer complications, reduced surgical time and lower cost. The purpose of this study is to determine if any difference exists in patient reported and surgical outcomes 1 year after surgery between operative and non-operative treatment of medial malleolar fractures in combination with stabilisation of the lateral malleolus.Methods/designThis is a single-centre, prospective, randomised controlled trial that aims to randomise 154 participants with an unstable ankle fracture to 'non-fixation' (n = 77) or 'fixation' (n = 77) of an associated well-reduced medial malleolus fracture following fibular stabilisation. The study will include patients ≥ 16 years of age with a closed bimalleolar or trimalleolar ankle fracture who are able to consent, complete questionnaires in the English language, and complete follow-up over a 1-year period. Randomisation will occur intra-operatively when the medial malleolus fracture is deemed 'well-reduced', with 2 mm or less of fluoroscopic displacement. The technique for fixation of both the medial and lateral malleoli is at the discretion of the operating surgeon. Patient-reported, observer-rated, and radiographic assessments will be collected at baseline and then at the following post-operative assessment points: 2 weeks, 6 weeks and 1 year. Postal questionnaire outcome data will be collected at 3 and 6 months. The primary outcome measure will be the Olerud Molander Ankle Score (OMAS) at 1 year following surgery. Secondary outcome measures will include the Manchester-Oxford Foot Questionnaire (MOXFQ), EuroQol-5D (EQ-5D), pain, treatment satisfaction, time to return to activity, operative tourniquet time, and complications.DiscussionThere is only one previous randomised trial comparing non-fixation with fixation of associated medial malleolus fractures but that was limited by the lack of baseline patient-reported outcome data and an inferior sample size. This current prospective trial aims to provide high-quality evidence regarding the requirement for medial malleolar fixation in unstable ankle fractures.Trial registrationClinicalTrials.gov, NCT03362229 . Registered retrospectively on 5 December 2017.

Project description:Of all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture.This multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study.Although displaced intra-articular distal radius fractures are common, there is still no evidence on the optimal treatment for these fractures in patients aged 18 to 65 years. Therefore we aim to determine the difference in functional outcome between open reduction and plate fixation and closed reduction and plaster immobilisation.This study is registered at ClinicalTrials.gov ( NCT02651779 ) on January 4(th) 2016.

Project description:BACKGROUND:Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. METHODS:For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. FINDINGS:Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63-1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06-3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79). INTERPRETATION:In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. FUNDING:National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.

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Operative treatment of displaced midshaft clavicle fractures: has randomised control trial evidence changed practice patterns?

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Operative treatment of displaced midshaft clavicle fractures: has randomised control trial evidence changed practice patterns?

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