N/A
N=57
Efficacy of Leg Casts With Heel Off-loaded in Children
Orthopedic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02468154 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group — 4.4; 3.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- custom made splint (Device); standard off-load plaster cast (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Istituto Ortopedico Rizzoli
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group |
4.4; 3.9 | — |
| SECONDARY 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; 5 | — |
| SECONDARY Health Staff/Caregiver Interventions |
2.1; 5.2 | — |
| SECONDARY Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10 |
8.9; 7.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02468154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.