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Heel-unloading Orthosis for Treatment of Calcaneus Fractures (CALCFRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03572816
Recruitment Status : Not yet recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Southern Denmark

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.

Condition or disease Intervention/treatment Phase
Calcaneus Fracture Orthopedic Devices Associated With Misadventures Device: Settner shoe Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
No Intervention: 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
Experimental: 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
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




Primary Outcome Measures :
  1. activity [ Time Frame: 3 months ]
    the number of active minutes per day


Secondary Outcome Measures :
  1. QoL [ Time Frame: 3 months ]
    the EuroQol 5D-3L questionnaire following

  2. QoL [ Time Frame: 6 months ]
    the EuroQol 5D-3L questionnaire following

  3. activity [ Time Frame: 6 months ]
    the number of active minutes per day


Other Outcome Measures:
  1. AOFAS [ Time Frame: 3 months ]
    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

  2. AOFAS [ Time Frame: 6 months ]
    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. Gait [ Time Frame: 3 months ]
    3-dimensional gait analysis

  4. Work [ Time Frame: 6 months ]
    time point of return to work

  5. Range of motion (ROM) [ Time Frame: 3 months ]
    Pro- and supination (percent of healthy side or assumed normal mobility) are analyzed.

  6. Range of motion (ROM) [ Time Frame: 6 months ]
    Pro- and supination (percent of healthy side or assumed normal mobility) are analyzed.

  7. pain [ Time Frame: 3 months ]

    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)


  8. pain [ Time Frame: 6 months ]

    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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572816


Contacts
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Contact: Hagen Schmal, Prof +45 2942 8705 hagen.schmal@rsyd.dk
Contact: Lasse Pedersen, MD +45 6541 3560 Lasse.Pedersen@rsyd.dk

Locations
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Denmark
University Hospital Odense
Odense, Region Of Southern Denmark, Denmark, 5000
Contact: Hagen Schmal, Prof    +45 2942 8705    hagen.schmal@rsyd.dk   
Contact: Lasse Pedersen, MD    +45 6541 3560    Lasse.Pedersen@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Principal Investigator: Hagen Schmal, Prof University Hospital Odense, Department of Orthopaedic Surgery
  Study Documents (Full-Text)

Documents provided by University of Southern Denmark:
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03572816    
Other Study ID Numbers: S-20170219
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan, may come.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries