Heel-unloading Orthosis for Treatment of Calcaneus Fractures

NCT03572816 | Unknown

• 1 other identifier: S-20170219
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcaneus Fracture; Orthopedic Devices Associated With Misadventures

Outcome Measures

Primary Outcomes (1)

• activity

  the number of active minutes per day

  3 months

Secondary Outcomes (3)

• QoL

  3 months

• QoL

  6 months

• activity

  6 months

Other Outcomes (8)

• AOFAS

  3 months

• AOFAS

  6 months

• Gait

  3 months

Study Arms (2)

Current standard

NO INTERVENTION

* 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

Intervention

EXPERIMENTAL

* 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

Device: Settner shoe

Interventions

Settner shoe 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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

University Hospital Odense

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (4)

• 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.

  PMID: 23440830 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

• 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.

  PMID: 1602349 BACKGROUND

• 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.

  PMID: 31164153 DERIVED

Study Officials

• Hagen Schmal, Prof

  University Hospital Odense, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagen Schmal, Prof

CONTACT

+45 2942 8705; hagen.schmal@rsyd.dk

Lasse Pedersen, MD

CONTACT

+45 6541 3560; Lasse.Pedersen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 28, 2018
• Study Start: August 1, 2018
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

DK (1)