Efficacy of Leg Casts With Heel Off-loaded in Children

Orthopedic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468154
• Other study ID #: 79/14
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: November 18, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Orthopedic Disorders

Intervention

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.

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 3 days during hospitalization and at cast removal (maximum 30 days).	No
Secondary	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).	Yes
Secondary	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 3 days during hospitalization	No
Secondary	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).	No