Evidence map›Paper›PMID 33563235›Full record

Trial reportBMC musculoskeletal disorders2021

Is early full weight bearing safe following locking plate ORIF of distal fibula fractures?

Michael Zyskowski, Markus Wurm, Frederik Greve, Sebastian Pesch, Francesca von Matthey, Patrick Pflüger, Moritz Crönlein, Peter Biberthaler, Chlodwig Kirchhoff

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

Trial report in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04370561 (a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% 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.

NCT04370561 nacompletednot on this map

a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates

TypeinterventionalSponsorTechnical University of MunichRan2016 to 2019Enrolled45ConditionsAnkle FracturesArmsORIF non-locking, ORIF locking
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  3. Plain X-ray is insufficient for correct diagnosis of tibial shaft spiral fractures: a prospective trial.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023
    Trial
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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

9 authors at 1 institution in 1 country.

Michael ZyskowskiKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Markus WurmKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Frederik GreveKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Sebastian PeschKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Francesca von MattheyKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Patrick PflügerKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Moritz CrönleinKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Peter BiberthalerKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany.
Chlodwig KirchhoffKlinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Unfallchirurgie, Ismaninger Str. 22, 81675, Munich, Germany. Chlodwig.Kirchhoff@mri.tum.de.ORCID http://orcid.org/0000-0002-8040-4384
TUM Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden. In this context open reduction internal fixation techniques allowing for early full weight bearing might not only improve the clinical outcome but also shorten the period of disability in working life. The aim of the study was to analyze whether ORIF of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome.

methodsIn this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score, Foot and Ankle outcome score and Karlsson and Peterson Scoring System for Ankle function. Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.

resultsFifty-two patients (31 W/21 M) with a mean age of 43 yrs. (range 22-64 yrs.) were enrolled. Seven patients (13.5%) were excluded, so that 45 patients were available for follow up. Twenty-five patients were treated with DePuy Synthes® one-third semitubular plate (55.6%; group I) while 20 patients received an anatomically preformed polyaxial locking plate (44.4%, group II). Four minor complications occurred in Group I (16%) compared to two minor complications in group II (10%). Significant better clinical results regarding OMAS (p < 0.02, < 0.04), KPSS (p < 0.04) and FAOS (p < 0.02, < 0.03) were observed 6 and 12 weeks after surgery in group II.

conclusionsThe results of the presented study demonstrate a significant better clinical functional outcome in the early postoperative follow-up in patients treated with a polyaxial locking plate. Furthermore, our data show that ORIF using polyaxial locking plates in combination with an early postoperative weight bearing presents a safe, stable treatment option for ankle fractures so that patients benefit especially in the early stages of recovery.

trial registrationRegistered 20 April 2020, retrospectively on ClinicalTrails.gov ( NCT04370561 ).

Indexed as

Ankle FracturesAdultBone PlatesFibulaFracture Fixation, InternalHumansProspective StudiesRetrospective StudiesTreatment OutcomeWeight-Bearing

Identifiers

PMID33563235
PMCPMC7874601
OpenAlexW3127430481

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.