Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01553630 · ClinicalTrials.gov registry record · NA
Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia
A NA study, sponsored by Florida Orthopaedic Institute.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT01553630 is a NA study that was terminated before completion, run by Florida Orthopaedic Institute. The registered enrollment target is 6 participants.
The verdict
NCT01553630, a NA study, was terminated before completion, sponsored by Florida Orthopaedic Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2/3 and C2/3 fractures of the distal femur and distal tibia treated with locked plates often have a critical sized fracture gap (poorly organized cortical pieces many of which are stripped of soft tissue). Optimal management strategies that minimize both fracture healing time and complication rates remain controversial. Primary bone grafts or early secondary bone grafts have been recommended for these comminuted open fractures, but have not been studied as the primary end point in a randomized trial. There is a need to study primary bone grafting during open reduction and internal fixation (plating) of these difficult fractures, to determine if shorter healing time, and thus less need for reoperation, can be achieved. Hypothesis Acute autogenous bone grafting at the time of fixation will hasten clinical and radiographic union with a lower need for secondary procedures
Interventions
- PROCEDURE RIA bone graft
- PROCEDURE Surgery without bone graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01553630
The ClinicalTrials.gov registry entry for NCT01553630 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida Orthopaedic Institute, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RIA bone graft is the first listed.
NCT01553630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01553630 about?
NCT01553630 is a clinical study titled "Reamed Locked Plating - Metaphyseal Fractures of the Distal Femur and Tibia". Comminuted metaphyseal fractures (OTA classification A2/3 and C2/3) of the distal femur and distal tibia are difficult to treat and typically have more complications than other metaphyseal fractures. Delayed union, nonunion and need for secondary bone graft procedures are frequent outcomes. These A2...
What is the current status of trial NCT01553630?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2010-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01553630?
The interventions under investigation include: RIA bone graft (PROCEDURE), Surgery without bone graft (PROCEDURE).
Who is sponsoring clinical trial NCT01553630?
This trial is sponsored by Florida Orthopaedic Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.