OPEN Research Support
head

Physician
Lasse Pedersen
Department of Orthopeadic Surgery, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.07.2018  
Slut 28.02.2021  
 



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

Short summary

Patients with fracture of the calcaneus, treated both operatively and non-operatively are traditionally treated with an orthosis (Static Walker).

In the current study, we aim to investigate, whether the use of a heel unloading orthosis (Settner shoe) will benefit patients, (18-65 years of age, treated both operatively and non-operatively) in terms of physical activity, quality of life, foot function, and time necessary for return to work.


Rationale

In the past decades, the scientific focus regarding calcaneus fractures was the choice of operative or non-operative treatment. Although the evidence is ambiguous, recent meta-analyses suggest that operative therapy is associated with a higher likelihood to resume pre-injury work, to reach a higher level of physical function and fewer problems when wearing shoes. However, non-operative therapy has significant less complications and infections. Typically, aftercare includes non- or partial weight bearing, but protocols are different and often not very specific. In fact, there are no studies published comparing different procedures or special supporting devices. Recently, a heel-unloading orthosis ('Settner shoe') was introduced in aftercare for calcaneus fractures, allowing walking by shifting the load to the middle- and forefoot. This orthosis does not only enable early mobilization of patients suffering one-sided fractures, but also permits walking following two-sided fractures, avoiding the otherwise necessary wheel-chair immobilization. The 'Settner shoe' can be applied in non-operative therapy and following 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 higher physical activity within the first 3 months and secondly improves ability to return to work in calcaneus fracture patients aged 18-65 years. Further outcome criteria are the American Orthopaedic Foot and Ankle Society's (AOFAS) ankle-hindfoot assessment, a 3-dimensional gait analysis, and the EQ-5D-3L questionnaire. It is the first trail applying a standardized aftercare in patients suffering from calcaneus fractures aiming to improve the non-operative part of treatment. Furthermore, the trial clarifies, whether the economical effort for the equipment acquisition is scientifically justified.


Description of the cohort

Patients between 18-65 years of age, suffering from acute calcaneus fracture. Able to give informed consent.


Data and biological material

Questionaires. X-rays. Gait analysis. Data from journal.


Collaborating researchers and departments

Department of Orthopaedics and Traumatology, Odense University Hospital.

  • Professor, MD, consultant surgeon Hagen Schmal
  • MD, consultant surgeon Carsen Fladmose Madsen
  • MD, PhD, consultant surgeon Lonnie Froberg
  • MD, consultant surgeon Lasse Pedersen
  • Julie Ladeby Erichsen.

Department of Clinical Research, University of Southern Denmark.

  • Anders Holsgaard Larsen