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Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia
Sponsor: Joaquín Moya-Angeler Pérez-Mateos
Summary
Title Early identification and treatment of developmental trochlear femoral dysplasia. Objectives To identify developmental trochlear femoral dysplasia (DTFD) in the newborn early after birth by ultrasound and evaluate the effect of its treatment with a modificed Pavlik harness. Study design Randomized triple-blind clinical trial. Study population Newborns with risk factors for the development of DTFD. Treatment of subjects Treatment using a modified Pavlik harness currently used for the treatment of developmental dysplasia of the hip (CDD) over a period of two months. Variables analyzed Trochlear groove angles measured by ultrasound before and after the intervention in the treatment group and control group. Follow-up Two weeks, eight weeks and six months. Statistic analysis Student's t test will be used for related samples to compare and analyze the results of each group at the beginning and after the treatment (intervention group) or follow-up (control group). Study will be triple blinded.
Key Details
Gender
All
Age Range
0 Months - 6 Months
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-06-01
Completion Date
2028-12-15
Last Updated
2024-03-12
Healthy Volunteers
Yes
Conditions
Interventions
pavlik harness
The application of a pavlik harness will be carried out in the intervention group. It will follow a protocol similar to that of the treatment of hip dysplasia in terms of follow-up and safety
Locations (1)
Hospital Virgen de la Arrixaca
Murcia, Spain