Efficacy of Leg Casts With Heel Off-loaded in Children

Not Applicable

Completed

• Conditions: Orthopedic Disorders
• Interventions: Device: custom made splint; Other: standard off-load plaster cast

• Registration Number: NCT02468154
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-02-08
• Results First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Results First Posted: 2016-05-18
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
splint	custom made splint	Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.
standard care	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

Primary Outcome Measures

Name	Time	Method
Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group	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

Name	Time	Method
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	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
Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10	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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy