CALCFRO
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
Sponsor study identifier
interventional
50
1 country
1
Study Start
August 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2018
Actual (reported)June 28, 2018
Actual (reported)August 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
activity
the number of active minutes per day
3 months
QoL
3 months
QoL
6 months
activity
6 months
AOFAS
3 months
AOFAS
6 months
Gait
3 months
* mobilization without weight bearing for 6 weeks starting with the day of either decision-making for non-operative therapy or open reduction and internal fixation, if needed a cast or another kind of orthosis as a Static Walker are applied, then 4 weeks 15-20 kg, 2 weeks 35-45 kg, after that transition to full-weight bearing (always only if possible) * X-ray after 6 and 12 weeks; depending on the results, the schedule for weight bearing may be adjusted to the need in case of delayed healing or complications related to implants
* mobilization with the custom-made heel-unloading orthosis ('Settner shoe') without pads for 6 weeks, then 2 weeks one pad, 2 weeks 2 pads, 2 weeks 3 pads, after that full-weight bearing without any support (always only if possible) * X-ray after 6 and 12 weeks; depending on the results, the schedule for weight bearing may be adjusted to the need in case of delayed healing or complications related to implants
custom-made heel-unloading orthosis ('Settner shoe') in aftercare of calcaneus fractures (used according to manufacturer), certified 'CE' product with more than 10 years experience
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Odense
Odense, Region Syddanmark, 5000, Denmark
Bruce J, Sutherland A. Surgical versus conservative interventions for displaced intra-articular calcaneal fractures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008628. doi: 10.1002/14651858.CD008628.pub2.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Sanders R. Intra-articular fractures of the calcaneus: present state of the art. J Orthop Trauma. 1992;6(2):252-65. doi: 10.1097/00005131-199206000-00022. No abstract available.
Hagen Schmal, Prof
University Hospital Odense, Department of Orthopaedic Surgery
First Submitted
May 28, 2018
First Posted
June 28, 2018
Study Start
August 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Schmal H, Larsen AH, Froberg L, Erichsen JL, Madsen CF, Pedersen L. 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. Trials. 2019 Jun 4;20(1):324. doi: 10.1186/s13063-019-3447-8.
Primary Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2018
Record last verified: 2018-06
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