Efficacy of Leg Casts With Heel Off-loaded in Children

Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorders
• Intervention / Treatment: Device: custom made splint; Other: standard off-load plaster cast

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		one time at cast removal (expected average of 30 days).
Health Staff/Caregiver Interventions	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	up to the first 2 days during hospitalization
Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10	The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived	one time at cast removal (expected average of 30 days).

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Luisa Veronesi, RN, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: April 12, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 79/14