Actively Recruiting
Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia
Led by Joaquín Moya-Angeler Pérez-Mateos · Updated on 2024-03-12
60
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy term and preterm newborns over 35 weeks
- Breech presentation at birth
You will not qualify if you...
- Infant cerebral palsy
- Developmental disorders
- Chromosomal diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
Research Team
J
Joaquín JM Moya-Angeler Pérez-Mateos, Orthopedic surgeon
CONTACT
D
Domingo DM Maestre Cano, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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