Evidence map›Paper›PMID 38191245›Full record

ArticleBMJ open2024

Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial.

Ola Saatvedt, Martin Riiser, Frede Frihagen, Wender Figved, Jan Erik Madsen, Marius Molund, Håvard Furunes

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04615650 (Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04615650 naactive not recruitingnot on this map

Non-operative Versus Operative Treatment of Suprasyndesmotic Ankle Fractures: A Prospective, Multicentre, Randomised Controlled Trial

TypeinterventionalSponsorSykehuset Innlandet HFRan2020 to 2025Enrolled120ConditionsAnkle FracturesArmsSurgical treatment, Ankle orthosis
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Ola SaatvedtDepartment of Orthopedic Surgery, Innlandet Hospital Trust Gjøvik Hospital, Gjovik, Norway ola.saatvedt@gmail.com.ORCID 0009-0009-8638-9195
Martin RiiserUniversity of Oslo Faculty of Medicine, Oslo, Norway.
Frede FrihagenDepartment of Orthopedic Surgery, Østfold Hospital Trust, Sarpsborg, Norway.
Wender FigvedDepartment of Orthopaedic Surgery, Bærum Hospital, Vestre Viken Hospital Trust, Bærum, Norway.
Jan Erik MadsenUniversity of Oslo Faculty of Medicine, Oslo, Norway.
Marius MolundDepartment of Orthopedic Surgery, Østfold Hospital Trust, Sarpsborg, Norway.
Håvard FurunesDepartment of Orthopedic Surgery, Innlandet Hospital Trust Gjøvik Hospital, Gjovik, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSurgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs. METHODS AND ANALYSIS: A non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of <7 mm will be subjected to weightbearing radiographs. If the tibio-talar joint is completely reduced, we will randomise in a 1:1 ratio to either operative treatment including reduction and fixation of the syndesmosis or non-operative treatment with an orthosis. The primary study outcome is patient-reported ankle function and symptoms as measured by the Olerud-Molander Ankle Score at 2-year follow-up. Secondary outcomes include the Manchester-Oxford Foot Questionnaire, range of motion, radiographic results and rates of adverse events. ETHICS AND DISSEMINATION: The Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT04615650.

Indexed as

Ankle FracturesAnkle JointFootHumansLower ExtremityMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicAdult orthopaedicsFoot & ankleOrthopaedic sports trauma

Identifiers

PMID38191245
PMCPMC10806705

What OpenQuestion holds

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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.