Evidence map›Paper›PMID 22954329›Full record

Trial reportBMC musculoskeletal disorders2012

Conservative treatment, plate fixation, or prosthesis for proximal humeral fracture. A prospective randomized study.

Antti P Launonen, Vesa Lepola, Tapio Flinkkilä, Niko Strandberg, Johanna Ojanperä, Pekka Rissanen, Antti Malmivaara, Ville M Mattila, Petra Elo, Timo Viljakka and 1 more

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

Trial report in BMC musculoskeletal disorders, 2012. 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 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
4.1field-weighted citation impact, top 6% 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

29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Interventions for treating proximal humeral fractures in adults.The Cochrane database of systematic reviews · 2022
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  18. High-Energy Proximal Humerus Fractures in Geriatric Patients: A Review.Geriatric orthopaedic surgery & rehabilitation · 2020
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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

11 authors at 6 institutions in 1 country.

Antti P LaunonenDepartment of Orthopaedics, Tampere University Hospital, Teiskontie 35, PL2000, Tampere 33521, Finland. antti.launonen@pshp.fi
Vesa Lepola
Tapio Flinkkilä
Niko Strandberg
Johanna Ojanperä
Pekka Rissanen
Antti Malmivaara
Ville M Mattila
Petra Elo
Timo Viljakka
Minna Laitinen
Tampere University Hospital · FITampere University · FIFinnish Institute for Health and Welfare · FIKuopio University Hospital · FIOulu University Hospital · FITurku University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProximal humerus fracture is the third most common fracture type after hip and distal radius fracture in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best treatment method. Several publications, including a Cochrane review outline the need for high-quality, well-designed randomized controlled trials. METHODS/

designThe study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score and the secondary outcome measures will be the EuroQol-5D (EQ-5D) value, OSS, Constant-Murley Score, VAS, and 15D.Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period. DISCUSSION: This publication presents a prospective, randomized, national multi-center trial. It gives details of patient flow, randomization, aftercare and also ways of analysis of the material and ways to present and publish the results.

trial registrationClinicalTrials.gov identifier: NCT01246167.

Indexed as

Bone PlatesInternal FixatorsJoint ProsthesisFollow-Up StudiesHumansProspective StudiesShoulder FracturesTreatment Outcome

Identifiers

PMID22954329
PMCPMC3520878
OpenAlexW2039665265

What OpenQuestion holds

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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.