NCT03572816: CALCFRO

Heel-unloading Orthosis for Treatment of Calcaneus Fractures

Status unknown NA Last updated 28 June 2018

What this trial tests

NA trial testing Settner shoe in Calcaneus Fracture in 50 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
31 January 2021

31 December 2021

Quick facts

Lead sponsor	University of Southern Denmark
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 August 2018
Primary completion	31 January 2021
Estimated completion	31 December 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Settner shoe

Conditions studied

• Calcaneus Fracture — all drugs for Calcaneus Fracture →
• Orthopedic Devices Associated With Misadventures — all drugs for Orthopedic Devices Associated With Misadventures →

Sponsor

University of Southern Denmark

Who can join

Adults 18 to 65, any sex, with Calcaneus Fracture or Orthopedic Devices Associated With Misadventures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Treatment of acute calcaneus fractures 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, allowing walking by shifting the load to the middle- and forefoot. 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, the investigators 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 18-60 years.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Schmal H, Larsen AH, Froberg L, Erichsen JL, et al · · 2019 · cited 2× · PMID 31164153 · DOI 10.1186/s13063-019-3447-8
2. 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
   Schmal H, Larsen AH, Froberg L, Erichsen JL, et al · · 2019 · DOI 10.21203/rs.2.213/v2