CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
custom made splint +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02468154
NCT02468154N/ACompleted

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

Istituto Ortopedico Rizzoli·interventional·Posted Jun 10, 2015·Updated May 18, 2016

In Brief

A clinical study evaluating custom made splint and standard off-load plaster cast for Orthopedic Disorders. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2015
Enrollment StartNov 1, 2014
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.1 years ago

Interventions

custom made splintdevice

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.

standard off-load plaster castother

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