Evidence map›Paper›PMID 35655280›Full record

ArticleTrials2022

Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.

Dennis Karimi, Stig Brorson, Kaare S Midtgaard, Tore Fjalestad, Aksel Paulsen, Per Olerud, Carl Ekholm, Olof Wolf, Bjarke Viberg, SHAFT Collaborators

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04574336 (Scandinavian Humeral diAphyseal Fracture Trial - A Pragmatic Randomized Controlled Trial), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT04574336 narecruitingnot on this map

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

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

10 authors.

Dennis KarimiDepartment of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark. dennis.karimi@rsyd.dk.ORCID http://orcid.org/0000-0003-3135-7435
Stig BrorsonDepartment of Orthopedic Surgery, Centre for Evidence-Based Orthopaedics, Zealand University Hospital, Køge, Denmark.
Kaare S MidtgaardDepartment of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.
Tore FjalestadDepartment of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway.
Aksel PaulsenDepartment of Orthopedic Surgery, Stavanger University Hospital, Stavanger, Norway.
Per OlerudDepartment of Orthopedic Surgery, Stockholm South General Hospital, Stockholm, Sweden.
Carl EkholmDepartment of Orthopedic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
Olof WolfDepartment of Surgical Sciences, Section of Orthopedics, Uppsala University, Uppsala, Sweden.
Bjarke VibergDepartment of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark.
SHAFT Collaborators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures.

methodsA pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality. DISCUSSION: The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery.

trial registrationClinicaltrials.gov NCT04574336 . Registered on 5 October 2020.

Indexed as

Humeral FracturesAgedFracture Fixation, InternalHumansHumerusMulticenter Studies as TopicPatient Reported Outcome MeasuresPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTreatment OutcomeDelayed unionDiaphyseal fractureHumeral shaft fractureNon-surgicalPatient-reported outcomesRandomized Controlled TrialSurgical fixationTreatment

Identifiers

PMID35655280
PMCPMC9161482

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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.