Clinical trial NCT03572816: Heel-unloading Orthosis for Treatment of Calcaneus Fractures
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calcaneus Fracture
Orthopedic Devices Associated With Misadventures
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a parallel group, randomized controlled trial with open allocation including all patients with calcaneus fractures independent of kind of initial therapy.
Primary purpose: TREATMENT

Brief 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.

Detailed 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?

Eligibility criteria: 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)

Primary outcomes:
measure: activity
timeFrame: 3 months
Secondary outcomes:
measure: QoL
timeFrame: 3 months
measure: QoL
timeFrame: 6 months
measure: activity
timeFrame: 6 months
Other outcomes:
measure: AOFAS
timeFrame: 3 months
measure: AOFAS
timeFrame: 6 months
measure: Gait
timeFrame: 3 months
measure: Work
timeFrame: 6 months
measure: Range of motion (ROM)
timeFrame: 3 months
measure: Range of motion (ROM)
timeFrame: 6 months
measure: pain
timeFrame: 3 months
measure: pain
timeFrame: 6 months
Locations:
city: Odense
country: Denmark
facility: University Hospital Odense
state: Region Of Southern Denmark
Study officials:
affiliation: University Hospital Odense, Department of Orthopaedic Surgery
name: Hagen Schmal, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.