Trial reportBMC musculoskeletal disorders2011
Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial.
Trial report in BMC musculoskeletal disorders, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Surgical versus conservative interventions for treating fractures of the middle third of the clavicle.The Cochrane database of systematic reviews · 2019Pooled it
- Operative versus nonoperative treatment of displaced midshaft clavicle fractures in adults: a systematic review.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2014Pooled it
- Should displaced midshaft clavicular fractures be treated surgically? A meta-analysis based on current evidence.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2013Pooled it
- [Operative versus nonoperative treatment of displaced midshaft clavicular fractures : a meta-analysis of randomized clinical trials].Der Unfallchirurg · 2012Pooled it
- Trial
- Clinical outcome and radiographic change of ipsilateral scapular neck and clavicular shaft fracture: comparison of operation and conservative treatment.Journal of orthopaedic surgery and research · 2015Trial
- Clinical outcome and operative cost comparison: Locked compression plate versus reconstruction plate in midshaft clavicle fractures.Acta orthopaedica et traumatologica turcica · 2020Article
- Article
- Demographics of the injury pattern in severely injured patients with an associated clavicle fracture: a retrospective observational cohort study.World journal of emergency surgery : WJES · 2013Article
- Preferences of orthopedic surgeons for treating midshaft clavicle fracture in adults.Einstein (Sao Paulo, Brazil)Article
- Bilateral Fracture Clavicles occurring Simultaneously and treated with Intramedullary Fixation.Journal of orthopaedic case reportsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries.
aimA prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. METHODS/
designA total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. DISCUSSION: This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.
trial registrationNetherlands National Trial Register NTR2399.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.