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NCT01375218 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
A Phase 4 study, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01375218: Completed Phase 4 study, sponsored by OrthoCarolina Research Institute.
NCT01375218 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375218, a Phase 4 study, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.
Primary Outcome
Negative Barlow and Ortolani tests as well as improvement/normalization in ultrasound measured alpha angle and femoral head coverage
Interventions
- OTHER Pavlik Brace
- OTHER Plastizote Brace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01375218 record still lists
NCT01375218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Pavlik Brace is the first listed.
NCT01375218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01375218 about?
NCT01375218 is a clinical study titled "Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants". The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The ...
What is the current status of trial NCT01375218?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01375218?
The interventions under investigation include: Pavlik Brace (OTHER), Plastizote Brace (OTHER).
Who is sponsoring clinical trial NCT01375218?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01375218's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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