NCT02468154

Efficacy of Leg Casts With Heel Off-loaded in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-06-10
• Last updated: 2016-05-18
• Results posted: 2016-05-18

Locations

1 site across 1 country: Italy