Evidence map›Paper›PMID 31318863›Full record

ArticlePLoS medicine2019

Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.

Antti P Launonen, Bakir O Sumrein, Aleksi Reito, Vesa Lepola, Juha Paloneva, Kenneth B Jonsson, Olof Wolf, Peter Ström, Hans E Berg, Li Felländer-Tsai and 9 more

Registry-linked trialOpen access · goldAbstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Article in PLoS medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01246167 (An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients), which is not on this map. Cited by 53 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 8 pooled it
8.8field-weighted citation impact, top 2% 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.

NCT01246167 nacompletednot on this map

An International, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Conservative, Plate Fixation and Prosthesis in Treatment of Displaced 2, 3, and 4 Part Fractures of Proximal Humerus of 60 Years and Older Patients

TypeinterventionalSponsorTampere University HospitalRan2011 to 2019Enrolled250ConditionsHumeral Fractures, ProximalArmsPhilos, Epoca, Control group
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 8 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Pooled it
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  6. The fragility and reverse fragility indices of proximal humerus fracture randomized controlled trials: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2022
    Pooled it
  7. Interventions for treating proximal humeral fractures in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  8. Pooled it
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  19. Long-term functional outcomes of non-operative treatment in patients with humeral surgical neck fractures.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025
    Article
  20. 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

19 authors at 7 institutions in 4 countries.

Antti P LaunonenFaculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.ORCID 0000-0002-3125-0171
Bakir O SumreinFaculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.ORCID 0000-0002-8267-8653
Aleksi ReitoDepartment of Orthopaedics, Central Finland Central Hospital, Jyväskylä, Finland.ORCID 0000-0002-6903-6461
Vesa LepolaFaculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.
Juha PalonevaDepartment of Orthopaedics, Central Finland Central Hospital, Jyväskylä, Finland.ORCID 0000-0003-3340-9390
Kenneth B JonssonDepartment of Orthopaedics, Institute of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Olof WolfDepartment of Orthopaedics, Institute of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.ORCID 0000-0001-6668-8715
Peter StrömDepartment of Orthopaedics, Institute of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Hans E BergDivision of Orthopedics and Biotechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0001-6475-8564
Li Felländer-TsaiDivision of Orthopedics and Biotechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Karl-Åke JanssonDivision of Orthopedics and Biotechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Daniel FellDivision of Orthopedics and Biotechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0001-5440-3559
Inger MechlenburgDepartment of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.
Kaj DøssingOrthopedics Department, Viborg Regional Hospital, Viborg, Denmark.ORCID 0000-0002-9657-6076
Helle ØstergaardOrthopedics Department, Viborg Regional Hospital, Viborg, Denmark.ORCID 0000-0002-8986-044X
Aare MärtsonDepartment of Traumatology and Orthopedics, Tartu University Hospital and Tartu University, Tartu, Estonia.ORCID 0000-0003-4857-484X
Minna K LaitinenFaculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.ORCID 0000-0002-9975-0121
Ville M MattilaFaculty of Medicine and Health Technology, University of Tampere and Tampere University Hospital, Tampere, Finland.
as the NITEP group
Tampere University Hospital · FIKarolinska University Hospital · SEUppsala University Hospital · SECentral Finland Health Care District · FIRegionshospitalet Viborg · DKAarhus University · DKTartu University Hospital · EE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. METHODS AND

findingsThe NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded.

conclusionsThis trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial.

trial registrationClinicalTrials.gov NCT01246167.

Indexed as

Fracture Fixation, InternalFracture HealingPhysical Therapy ModalitiesAgedAged, 80 and overBone PlatesEuropeFemaleFracture FixationHumansMaleMiddle AgedOrthotic DevicesPostoperative PainQuality of LifeRecovery of Function

Identifiers

PMID31318863
PMCPMC6638737
OpenAlexW2956627648

What OpenQuestion holds

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LicenceCC BY
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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.