Heel-unloading Orthosis for Treatment of Calcaneus Fractures

Calcaneus Fracture Clinical Trial

— CALCFRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03572816
• Other study ID #: S-20170219
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2018
• Source: University of Southern Denmark
• Contact: Hagen Schmal, Prof
• Phone: +45 2942 8705
• Email: hagen.schmal[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In the past decades, the scientific focus regarding calcaneus fractures was the choice of operative or non-operative treatment modality. 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 going following two-sided fractures, avoiding the otherwise necessary wheel-chair mobilization. The 'Settner shoe' can be applied in non-operative therapy and following operations. 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. 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.

The investigators hypothesize that mobilization with the 'Settner shoe' results in higher physical activity within the first 3 months after calcaneus fractures.

Research questions

Does the application of a heel-unloading orthosis ('Settner shoe') independent of operative or non-operative therapy of a calcaneus fracture improve:

1. the physical activity (active minutes per day)?

2. the quality of life (EQ-5D-3L)?

3. the foot function (AOFAS)?

4. the time necessary for return to work in patients between 18 and 60 years?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Fracture of the calcaneus, which is classifiable according to the Sanders' classification (excludes avulsion fractures)

• Being able to understand Danish or English and answer the questionnaires

• Informed consent

Exclusion Criteria:

• Pathological fractures

• Immature skeletal system

• Other fractures with influence on weight-bearing

• A soft-tissue situation not allowing the equipment with a 'Settner shoe' within 3 weeks after treatment (either decision-making for non-operative therapy or open reduction and internal fixation)

Related Conditions & MeSH terms

• Calcaneus Fracture
• Fractures, Bone
• Orthopedic Devices Associated With Misadventures

Intervention

Device:
• Settner shoe
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

Locations

Country	Name	City	State
Denmark	University Hospital Odense	Odense	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. Review. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Sanders R. Intra-articular fractures of the calcaneus: present state of the art. J Orthop Trauma. 1992;6(2):252-65. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AOFAS	functional foot score, The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points	3 months
Other	AOFAS	functional foot score, The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points	6 months
Other	Gait	3-dimensional gait analysis	3 months
Other	Work	time point of return to work	6 months
Other	Range of motion (ROM)	Pro- and supination (percent of healthy side or assumed normal mobility) are analyzed.	3 months
Other	Range of motion (ROM)	Pro- and supination (percent of healthy side or assumed normal mobility) are analyzed.	6 months
Other	pain	The subjective pain of patients is assessed using a Visual Analog Scale (VAS) in combination with registration of their pain medication, which is classified according to the WHO pain ladder. The Summary Pain Score (SPS) is calculated from the sum of the two components.; VAS 0 (best) - 10 (worst) WHO scale for pain medication 0 (best, lowest) - 5 (worst, highest)	3 months
Other	pain	The subjective pain of patients is assessed using a Visual Analog Scale (VAS) in combination with registration of their pain medication, which is classified according to the WHO pain ladder. The Summary Pain Score (SPS) is calculated from the sum of the two components.; VAS 0 (best) - 10 (worst) WHO scale for pain medication 0 (best, lowest) - 5 (worst, highest)	6 months
Primary	activity	the number of active minutes per day	3 months
Secondary	QoL	the EuroQol 5D-3L questionnaire following	3 months
Secondary	QoL	the EuroQol 5D-3L questionnaire following	6 months
Secondary	activity	the number of active minutes per day	6 months

External Links

•   description of device