Evidence map›Paper›PMID 31383027›Full record

ArticleTrials2019

A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol.

William M Oliver, Thomas H Carter, Catriona Graham, Timothy O White, Nicholas D Clement, Andrew D Duckworth, Samuel G Molyneux

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT03689335 nacompletednot on this map

A Prospective Randomised Controlled Trial of Operative Versus Nonoperative Management of Fractures of the Humeral Diaphysis

TypeinterventionalSponsorRoyal Infirmary of EdinburghRan2018 to 2023Enrolled70ConditionsClosed Fracture of Shaft of HumerusArmsOperative, Humeral brace
NCT04574336 narecruitingnot on this mapstarted 2022, after this paper: background citation

Scandinavian Humeral diAphyseal Fracture Trial - A Pragmatic Randomized Controlled Trial

TypeinterventionalSponsorKolding SygehusRan2022 to 2031Enrolled287ConditionsFracture Humerus of ShaftArmsSurgical treatment, Non-surgical treatment
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. A Scoring System for Predicting Nonunion After Intramedullary Nailing of Femoral Shaft Fractures.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2024
    Article
  5. Article
  6. Article
  7. Article
  8. [Antegrade and retrograde nailing of humeral shaft fractures].Operative Orthopadie und Traumatologie · 2021
    Article
  9. 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

7 authors at 1 institution in 1 country.

William M OliverEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK. william.m.oliver@doctors.org.uk.ORCID http://orcid.org/0000-0001-8976-2260
Thomas H CarterEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Catriona GrahamEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Timothy O WhiteEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Nicholas D ClementEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Andrew D DuckworthEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Samuel G MolyneuxEdinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, Midlothian, EH16 4SA, UK.
Edinburgh Royal Infirmary · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHumeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-operatively, with operative fixation reserved for specific indications. Although some recent retrospective studies have suggested there are potential benefits of operative fixation over humeral bracing, there is a deficiency in level 1 evidence to support operative management as the primary treatment for humeral shaft fractures. METHODS/

designThis single-centre prospective randomised controlled trial aims to recruit 70 adult patients with an isolated closed fracture of the humeral diaphysis into one of two treatment arms: operative (n = 35) or non-operative (n = 35). The operative arm will undergo open reduction and internal fixation (ORIF) of the fracture using a standard fixation technique (plate and screws). The non-operative arm will be fitted with a prefabricated humeral brace until fracture union. All patients will be followed up for 1 year post-intervention. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at 3 months post-intervention. Secondary outcome measures will include pain, treatment complications, return to work or sporting activities, shoulder and elbow range of motion, radiographic assessment, EuroQol (EQ-5D) Health Outcome score and 12-item Short Form (SF-12) Health Survey score. A health economic analysis will be performed to compare the cost implications of each treatment strategy. DISCUSSION: This randomised controlled trial will provide level 1 evidence comparing a standard ORIF technique against functional bracing for isolated closed humeral shaft fractures. The investigators hope that the study results will assist surgeons in their decision-making when managing patients with these injuries.

trial registrationClinicalTrials.gov, NCT03689335 . Registered on 28 September 2018 (retrospectively).

Indexed as

Randomized Controlled Trials as TopicAdultFracture Fixation, InternalHumansHumeral FracturesOutcome Assessment, Health CareProspective StudiesBracingDiaphysisFixationFractureHumeralHumerusNon-operativeOperativePatient outcomeRandomised controlled trialShaftTrauma

Identifiers

PMID31383027
PMCPMC6683573
OpenAlexW2964393671

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.