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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: Clinical Trial NA study, sponsored by Florida Orthopaedic Institute.
NCT01553630 is a NA study that was terminated before completion, run by Florida Orthopaedic Institute. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
This will be evaluated with the reading of xrays
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 |
Why NCT01553630 stopped before completion
NCT01553630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which RIA bone graft is the first listed.
NCT01553630 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01553630's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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