Evidence map›Paper›PMID 31164153›Full record

ArticleTrials2019

The effect of a heel-unloading orthosis in short-term treatment of calcaneus fractures on physical function, quality of life and return to work - study protocol for a randomized controlled trial.

Hagen Schmal, Anders Holsgaard Larsen, Lonnie Froberg, Julie Ladeby Erichsen, Carsten Fladmose Madsen, Lasse Pedersen

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03572816 (The Effect of a Heel-unloading Orthosis in Short-term Treatment of Calcaneus Fractures on Physical Function, Quality of Life and Return to Work - a Randomized Controlled Trial), 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

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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.

NCT03572816 naunknown statusnot on this map

The Effect of a Heel-unloading Orthosis in Short-term Treatment of Calcaneus Fractures on Physical Function, Quality of Life and Return to Work - a Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Southern DenmarkRan2018 to 2021Enrolled50ConditionsCalcaneus Fracture, Orthopedic Devices Associated With MisadventuresArmsSettner shoe
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

6 authors.

Hagen SchmalDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark. hagen.schmal@freenet.de.ORCID http://orcid.org/0000-0002-8801-2385
Anders Holsgaard LarsenDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.
Lonnie FrobergDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.
Julie Ladeby ErichsenDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.
Carsten Fladmose MadsenDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.
Lasse PedersenDepartment of Orthopedics and Traumatology, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Odense, Denmark.

Funding

Ingemann O. Buck's fond A2645
6 · The paper itself

Abstract

backgroundThere are no standardized therapy guidelines for rehabilitation of calcaneus fractures. While there is consensus on non or partial weight-bearing, the use of supporting devices such as specific foot ankle orthosis is still a matter of debate. Recently, a heel-unloading orthosis ("Settner shoe") was introduced for aftercare of these fractures, allowing walking by shifting the load to the middle-foot and forefoot. This orthosis enables early mobilization of patients suffering from either one-sided or two-sided fractures. The Settner shoe can be applied in non-operative therapy and after surgery. Specifically in calcaneus fractures, early regain of physical activity has been highlighted as one of the key factors for quality of life and the ability to return to work. Thus, we hypothesize that mobilization with the Settner shoe results in improved quality of life and greater physical activity within the first 3 months.

methodsThis is going to be analyzed by a randomized controlled study comparing treatment with and without this specific orthosis. The secondary outcome measure is the time point of return to work in patients aged between 18 and 60 years, with calcaneus fracture. Furthermore, the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, a 3-dimensional gait analysis, and the Euroqol-5 dimension-3 level (EQ-5D-3 L) questionnaire for quality of life are assessed. DISCUSSION: This is the first trial applying a standardized rehabilitation protocol in patients with calcaneus fractures, aiming to improve the non-operative part of treatment by use of an orthosis.

trial registrationClinicalTrials.gov, NCT03572816 . Registered on 27 July 2018.

Indexed as

Foot OrthosesQuality of LifeReturn to WorkWeight-BearingAdolescentAdultAgedCalcaneusDenmarkEquipment DesignFemaleFoot InjuriesFractures, BoneGaitHealth StatusHumansAftercareAnkle foot orthosisCalcaneus fractureRehabilitationStudy protocol

Identifiers

PMID31164153
PMCPMC6549309

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.