Trial Outcomes & Findings for Efficacy of Leg Casts With Heel Off-loaded in Children (NCT NCT02468154)

Results Overview

All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

up to the first 2 days during hospitalization and at cast removal (maximum 30 days).

Results posted on

2016-05-18

Participant Flow

Between November 2014-August 2015, 57 paediatric orthopaedic patients who need a lower limb plaster cast after surgery out of the 172 potentially eligible (33.1%) were enrolled in the trial.

Participant milestones

Participant milestones
Measure	Splint Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	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 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
Overall Study STARTED	29	28
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Leg Casts With Heel Off-loaded in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Splint n=29 Participants Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	Standard Care n=28 Participants 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 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	Total n=57 Participants Total of all reporting groups
Age, Continuous	10.4 years STANDARD_DEVIATION 3.96 • n=5 Participants	10.5 years STANDARD_DEVIATION 3.72 • n=7 Participants	10.5 years STANDARD_DEVIATION 3.84 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Italy	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants
bone surgical intervention (vs soft tissue surgical intervention)	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants
spica cast	9 participants n=5 Participants	4 participants n=7 Participants	13 participants n=5 Participants
over the knee cast	11 participants n=5 Participants	16 participants n=7 Participants	27 participants n=5 Participants
under the knee cast	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants
pain killer (opioid)	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Splint n=29 Participants Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	Standard Care n=28 Participants 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 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
Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group	4.4 units on a scale Standard Deviation 2.4	3.9 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: one time at cast removal (expected average of 30 days).

Outcome measures

Outcome measures
Measure	Splint n=29 Participants Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	Standard Care n=28 Participants 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 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
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.	1 participants	5 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Splint n=29 Participants Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	Standard Care n=28 Participants 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 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
Health Staff/Caregiver Interventions	2.1 daily number of interventions Standard Deviation 3.2	5.2 daily number of interventions Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Splint n=29 Participants Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded. 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.	Standard Care n=28 Participants 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 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
Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10	8.9 units on a scale Standard Deviation 1.1	7.6 units on a scale Standard Deviation 1.7

Adverse Events

Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Luisa Veronesi

Istituto Ortopedico Rizzoli

Phone: 0516366694

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place