Evidence map›Paper›PMID 27142768›Full record

Trial reportTrials2016

Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial.

Mario Lenza, Luiz Fabiano Presente Taniguchi, Mario Ferretti

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02398006 (Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02398006 naunknown statusnot on this map

Figure-of-eight Bandage Versus Arm Sling for Treating Middle Third Clavicle Fractures in Adults: Study Protocol for a Randomised Controlled Trial

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2015 to 2017Enrolled110ConditionsFracture of ClavicleArmsa standard arm sling, a figure-of-eight bandage
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Adult Clavicular Fracture Case Report.Journal of education & teaching in emergency medicine · 2020
    Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Mario LenzaHospital Israelita Albert Einstein, Avenida Albert Einstein, 627/701 - Jardim Leonor, CEP: 05652-900, São Paulo, SP, Brazil. mario.lenza@einstein.br.
Luiz Fabiano Presente TaniguchiHospital Israelita Albert Einstein, Avenida Albert Einstein, 627/701 - Jardim Leonor, CEP: 05652-900, São Paulo, SP, Brazil.
Mario FerrettiHospital Israelita Albert Einstein, Avenida Albert Einstein, 627/701 - Jardim Leonor, CEP: 05652-900, São Paulo, SP, Brazil.
Hospital Israelita Albert Einstein · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFracture of the clavicle is common, accounting for 2.6 to 4.0 % of all fractures, with an overall incidence of 36.5 to 64 per 100,000 per year. Around 80 % of clavicle fractures occur in the middle third of the clavicle. Randomised controlled trials comparing treatment interventions have failed to indicate the best therapeutic practices for these fractures. The objective of this study is to evaluate the effects (benefits and harms) of two commonly-used conservative interventions: the figure-of-eight bandage versus the arm sling as treatments of middle-third clavicle fractures. METHODS/

designThis project has been designed as a single-centre, two-arm randomised controlled trial that will compare two interventions: figure-of-eight bandage versus the arm sling. We propose to recruit 110 adults, aged 18 years or older, with an acute (less than 10 days since injury) middle-third clavicle fracture. The primary outcomes to be evaluated will be function and/or disability measured by the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire. In order to assess the secondary outcomes, the Modified University of California at Los Angeles (modified - UCLA) Shoulder Rating Scale will be used. The occurrence of pain (Visual Analogue Scale for pain (VAS)), treatment failure, adverse events and the ability to return to previous activities will also be recorded and evaluated as secondary outcomes. DATA ANALYSIS: the primary outcome DASH score and the secondary outcomes - modified UCLA and VAS scores - will be analysed graphically. We will apply generalised mixed models with the intervention groups (two levels), and time-point assessments (seven levels) as fixed effects and patients as a random effect. DISCUSSION: According to the current literature there is very limited evidence from two small trials regarding the effectiveness of different methods of conservative interventions for treating clavicle fractures. This is the first randomised controlled trial comparing the figure-of-eight bandage versus the arm sling for treating clavicle fractures that follows the CONSORT Statement guidelines.

trial registrationClinicalTrials.gov NCT02398006 .

Indexed as

BandagesFracture HealingAdolescentAdultAgedBrazilClavicleClinical ProtocolsDisability EvaluationFemaleFractures, BoneHumansMaleMiddle AgedOrthopedic ProceduresPain MeasurementBoneClavicleConservative treatmentFracture healingFracturesPseudarthrosisTreatment outcome

Identifiers

PMID27142768
PMCPMC4855803
OpenAlexW2346712872

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.