Heel-unloading Orthosis for Treatment of Calcaneus Fractures

NCT ID: NCT03572816

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2021-12-31

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?

Conditions

Calcaneus Fracture; Orthopedic Devices Associated With Misadventures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Current standard

• 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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

• 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

Group Type: EXPERIMENTAL

Settner shoe

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagen Schmal, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Odense, Department of Orthopaedic Surgery

Locations

University Hospital Odense

Odense, Region Syddanmark, Denmark

Countries

Denmark

Central Contacts

Hagen Schmal, Prof

Role: CONTACT

hagen.schmal@rsyd.dk

+45 2942 8705

Lasse Pedersen, MD

Role: CONTACT

Lasse.Pedersen@rsyd.dk

+45 6541 3560

Facility Contacts

Hagen Schmal, Prof

Role: primary

hagen.schmal@rsyd.dk

+45 2942 8705

Lasse Pedersen, MD

Role: backup

Lasse.Pedersen@rsyd.dk

+45 6541 3560

References

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.

Reference Type: BACKGROUND

PMID: 23440830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10109801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1602349 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31164153 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: original version in Danish

View Document

Document Type: Informed Consent Form: translated version in English

View Document

Other Identifiers

S-20170219

Identifier Type: -

Identifier Source: org_study_id