Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia
Recruiting now · Not applicable
Conditions studied: TROCLEAR DYSPLASIA
In brief
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 facts
- Study ID
- NCT05081453
- Run by
- Joaquín Moya-Angeler Pérez-Mateos
- People needed
- 60
- Starts
- 2023-06-01
- Expected to finish
- 2028-12-15
- Last updated by the study team
- 2024-03-12
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy term and preterm newborns > 35 weeks
- Breech presentation at birth.
You may not qualify if…
- Infant cerebral palsy,
- Developmental disorders
- Chromosomal diseases.
Where it is running
- Hospital Virgen de la Arrixaca — Murcia, Spain (enrolling)
Full record on ClinicalTrials.gov
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