Evidence map›Paper›PMID 39558368›Full record

ArticleTrials2024

Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial.

Coen Verstappen, Mitchell L S Driessen, Pishtiwan H S Kalmet, Lloyd Brandts, Merel Kimman, Michael Edwards, Erik Hermans, Martijn Poeze

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

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05721378 (), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05721378 narecruitingnot on this map

(Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial

TypeinterventionalSponsorMaastricht University Medical CenterRan2024 to 2026Enrolled115ConditionsCalcaneus Fracture, Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), Trauma InjuryArmsPermissive Weight Bearing group, Restricted Weight Bearing group
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

8 authors.

Coen VerstappenDepartment of Trauma Surgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands. Coen.Verstappen@mumc.nl.ORCID http://orcid.org/0000-0003-0254-7002
Mitchell L S DriessenDepartment of Trauma Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, The Netherlands.ORCID http://orcid.org/0000-0002-9699-5422
Pishtiwan H S KalmetDepartment of Trauma Surgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands.ORCID http://orcid.org/0000-0002-3478-6932
Lloyd BrandtsDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, The Netherlands.ORCID http://orcid.org/0000-0002-0620-1271
Merel KimmanDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, The Netherlands.ORCID http://orcid.org/0000-0002-5717-5704
Michael EdwardsDepartment of Trauma Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, The Netherlands.
Erik HermansDepartment of Trauma Surgery, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, The Netherlands.ORCID http://orcid.org/0000-0002-5884-3954
Martijn PoezeDepartment of Trauma Surgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, The Netherlands.ORCID http://orcid.org/0000-0001-5005-1285

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFollowing successful treatment, displaced intra-articular calcaneal fractures (DIACFs) necessitate an extensive rehabilitation regimen, significantly influencing functional and socio-economic outcomes. Apart from surgical intervention, the implementation of a comprehensive rehabilitation protocol is crucial to optimize foot stability and functional recovery. The objective of this study is to ascertain the optimal rehabilitation protocol for patients with surgically treated DIACFs, either permissive weight bearing (PWB) or Restricted Weight Bearing, focusing on functional outcomes, health-related quality of life (HRQoL), radiographic parameters, cost-effectiveness, and incidence of complications.

methodsStudy design: A prospective multicenter randomized controlled trial. STUDY POPULATION: Presence of surgically (extended lateral, sinus tarsi, or percutaneous approach) treated unilateral DIACFs (Sanders type II to IV), aged 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. N = 115 patients with DIACFs will be included.

interventionsPatients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB. PRIMARY OUTCOME MEASURE: Functional outcome, measured with the American Orthopaedic Foot & Ankle Society Score (AOFAS)). SECONDARY OUTCOMES: Functional outcome (Maryland Foot Score, MFS), HRQoL (EuroQol-5D, EQ-5D), differences in radiographic parameters, cost-effectiveness, and complications. Nature and extent of burden: The PWB protocol is aimed to be non-inferior to the RWB protocol. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks, and 6 months. The radiation exposure for both groups will differ from standard care (one extra CT scan of the foot will be made). Therefore, the burden for participants is considered minimal, with no significant health risks. DISCUSSION: This study will be the first study to define an optimal rehabilitation regime for surgically treated patients with DIACFs. The limitations of this study include the absence of patient blinding, as this is impossible in rehabilitation. Additionally, the primary outcome measure (AOFAS) has limited validity for DIACFs. However, it is the most commonly used questionnaire in the literature on DIACFs. There is an apparent need since current literature is lacking on this specific topic.

trial registrationClinicalTrials.gov NCT05721378, accepted on February 7, 2023.

Indexed as

CalcaneusQuality of LifeRecovery of FunctionWeight-BearingAdolescentAdultAgedCost-Benefit AnalysisFemaleHumansIntra-Articular FracturesMaleMiddle AgedMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicDisplaced intra-articular calcaneal fracturesPermissive weight bearingPostoperative treatmentRandomized controlled trialRehabilitationTrauma patients

Identifiers

PMID39558368
PMCPMC11572059

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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.