Identifying and treating developmental trochlear femoral dysplasia in newborns
Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia
This study is testing if using an ultrasound right after birth can help find a hip problem in newborns and if treating it with a special harness makes a difference over two months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Months to 6 Months |
| Sex | All |
| Sponsor | Hospital Universitario Virgen de la Arrixaca Academic / other |
| Locations | 1 site (Murcia) |
| Trial ID | NCT05081453 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify developmental trochlear femoral dysplasia (DTFD) in newborns shortly after birth using ultrasound. It evaluates the effectiveness of treatment with a modified Pavlik harness over a two-month period. The study employs a randomized triple-blind design, comparing outcomes between a treatment group and a control group. Key variables analyzed include trochlear groove angles measured before and after the intervention, with follow-up assessments at two weeks, eight weeks, and six months.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy term and preterm newborns over 35 weeks gestation who were in breech presentation at birth.
Not a fit: Patients with conditions such as cerebral palsy, developmental disorders, or chromosomal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more effective treatment of DTFD, potentially preventing long-term complications such as osteoarthritis.
How similar studies have performed: Other studies have shown success with similar early detection and treatment approaches for joint dysplasias, particularly in developmental dysplasia of the hip.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy term and preterm newborns \> 35 weeks * Breech presentation at birth. Exclusion Criteria: * Infant cerebral palsy, * Developmental disorders * Chromosomal diseases.
Where this trial is running
Murcia
- Hospital Virgen de la Arrixaca — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Joaquín JM Moya-Angeler Pérez-Mateos, Orthopedic surgeon
- Email: jmoyaangeler@gmail.com
- Phone: 669412133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.