Evaluating treatment duration for stable Graf IIc hips in children
How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?
This study is testing whether a shorter or standard 12-week treatment with a Pavlik Harness is better for babies with stable Graf type IIc hips who have Developmental Dysplasia of the Hip.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 0 Weeks to 18 Weeks |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03275805 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal duration of Pavlik Harness treatment for children diagnosed with Developmental Dysplasia of the Hip (DDH) who have stable Graf type IIc hips. Participants aged 0-18 weeks will be randomly assigned to receive either the standard 12-week treatment or a shorter duration based on normalization of their hip condition. The study aims to determine the most effective treatment length by analyzing follow-up radiographs at two years. This research addresses a gap in current orthopedic practices regarding the management of stable Graf IIc hips.
Who should consider this trial
Good fit: Ideal candidates are infants aged 0-18 weeks diagnosed with stable Graf type IIc hips and presenting with an abnormal ultrasound.
Not a fit: Patients with unstable hips or additional neurologic or teratologic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating children with stable Graf IIc hips, potentially improving treatment outcomes.
How similar studies have performed: While Pavlik Harness treatment is well-established, this specific investigation into the duration for Graf IIc hips is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with: * DDH * Graf IIc hips (alpha angle = 43-49 degrees) * normal hip exam (stable hips) * abnormal ultrasound Exclusion Criteria: 1. Patients with additional conditions: Neurologic or teratologic. 2. Follow up that occurs at any other institution. 3. Unstable hips
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Gaia Georgopoulos, MD — Children's Hospital Colorado
- Study coordinator: Reba L Salton, BS
- Email: reba.salton@childrenscolorado.org
- Phone: 7207770702
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.