Developmental Dysplasia of the Hip
Conditions
Brief summary
This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.
Interventions
OTHERDelta Dry® Waterproof Pantaloon
Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.
OTHERCotton Padding
Cast with traditional cotton liner.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
0 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Paediatric patients (\<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.
Exclusion criteria
* Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon * Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness as a measure of change in ratings at different time points | Baseline, 2, 6 and 12 weeks post-application | The primary outcome (effectiveness) will be measured based on the change in ratings to the following variables/factors using a 10 point likert scale (1 being very poor and 10 being excellent): Comfort, Ability for the cast to dry if it became wet, Cast odor, Cast durability, Protection from skin irritation, Ease of care in the cast, Ease of Application, Padding Aesthetics, Application Time, Skin Condition, Lack of Maceration / Excoriation, Cast Odor, Padding Condition, and Ease of Removal. These will be collected at baseline, 2, 6 and 12 weeks post-application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality | Baseline, 2, 6 and 12 weeks post-application | The secondary outcome (quality) will be measured based on rating to the following using a 10 point likert scale (1 being very poor and 10 being excellent): Overall Quality |
Countries
United States
Outcome results
None listed