Efficacy of Leg Casts With Heel Off-loaded in Children

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Orthopedic Disorders

Treatments: Device: custom made splint; Other: standard off-load plaster cast

Study type: Interventional

Funder types: Other

Identifiers

NCT02468154

79/14

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups

splint

Experimental group

Description:

Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.

Treatment:

Device: custom made splint

standard care

Active Comparator group

Description:

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

Treatment:

Other: standard off-load plaster cast