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Efficacy of Leg Casts With Heel Off-loaded in Children

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ClinicalTrials.gov Identifier: NCT02468154
Recruitment Status : Completed
First Posted : June 10, 2015
Results First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Study Description
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Brief Summary:
Assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.

Condition or disease Intervention/treatment Phase
Orthopedic Disorders Device: custom made splint Other: standard off-load plaster cast Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial
Study Start Date : November 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: splint
Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
 Device: custom made splint
Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs.
Active Comparator: standard care
To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
 Other: standard off-load plaster cast
To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane


Outcome Measures
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Primary Outcome Measures :
  1. Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group [ Time Frame: up to the first 2 days during hospitalization and at cast removal (maximum 30 days). ]
    All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain


Secondary Outcome Measures :
  1. Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P. [ Time Frame: one time at cast removal (expected average of 30 days). ]
  2. Health Staff/Caregiver Interventions [ Time Frame: up to the first 2 days during hospitalization ]
    daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver

  3. Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 [ Time Frame: one time at cast removal (expected average of 30 days). ]
    The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated by operations to the lower limbs which require immediate plaster casts that include the foot
  • Treated by osteotomy, joint fusion, patella repositioning and fracture fixation
  • Children with intact skin at the heel

Exclusion Criteria:

  • Caregivers who cannot speak Italian
  • Those who refuse to give their consent to take part in the study
  • Patients with lower limb casts that are allowed to load the limb
Contacts and Locations
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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): NCT02468154


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Luisa Veronesi, RN Istituto Ortopedico Rizzoli
More Information
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02468154    
Other Study ID Numbers: 79/14
First Posted: June 10, 2015    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016
Last Verified: September 2015
Additional relevant MeSH terms:
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Musculoskeletal Diseases