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The Treatment of Type I Open Fractures in Pediatrics
NCT00870064 · View on ClinicalTrials.gov ↗
Study Summary
Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective studies, centers are reporting less aggressive operative management for open fractures may result in equal results without the time and expense of the operative theater. The investigators propose a prospective, randomized trial of children with type I open fractures to evaluate whether formal operative treatment is necessary. The investigators' hypothesis is that minor open fractures can be safely treated in the emergency room with irrigation, closed reduction and home antibiotics without an increased risk of infection or other complications. Children who meet the study criteria will be randomized into two treatment arms - formal operative management (OR) and emergency department (ED) management. Outcomes from each group will be evaluated and compared, including rate of infection, number of return visits to the operating room, time to union, and other complications.
Conditions Studied
Interventions
- PROCEDURE Formal Operative Treatment
- PROCEDURE Emergency Department Treatment
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2010-03 |
| Est. Completion | 2026-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00870064
The ClinicalTrials.gov registry entry for NCT00870064 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fractures, Open appearing as the primary indexed condition, and to 2 interventions — of which Formal Operative Treatment is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00870064 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00870064 about?
NCT00870064 is a clinical study titled "The Treatment of Type I Open Fractures in Pediatrics". Open fractures are frequently encountered in orthopaedics. Treatment usually calls for a formal, operative procedure in which the bone is exposed, foreign tissue is debrided and the wound is irrigated. While this is the current standard of care, not all open fractures are equal. In retrospective stu...
What is the current status of trial NCT00870064?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2010-03. Estimated completion is 2026-06.
What conditions does trial NCT00870064 study?
This clinical trial studies the following conditions: Fractures, Open. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00870064?
The interventions under investigation include: Formal Operative Treatment (PROCEDURE), Emergency Department Treatment (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00870064?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 69 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00870064 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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