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NCT02845245 · ClinicalTrials.gov registry record · NA
Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques
A NA study, sponsored by Inova Health Care Services.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02845245 is a NA study that was terminated before completion, run by Inova Health Care Services. The registered enrollment target is 20 participants.
The verdict
NCT02845245, a NA study, was terminated before completion, sponsored by Inova Health Care Services.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of high-energy trauma such as motor vehicle collisions or fall from a height. They are complex injuries often associated with significant fragment displacement and severe soft tissue injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and displacement. Yet, in some cases, it is still difficult to identify the relationship among bone fragments, which often makes articular restoration challenging. As a result, patients with non-anatomic joint reconstructions have a higher rate of poor outcomes. The primary objective of this study will be to compare patient outcomes in two groups, one group who will receive enhanced pre-operative planning (3D printed plastic prototype + standard of care \[SOC\] imaging with 3D CT scan + plain film radiographs) and a second group who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film radiographs only). Patient outcomes collected throughout the 12 month post-operative period will include an assessment of radiographic fracture healing (union, non-union, malunion), pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's self-report, and development of complications (infection, wound healing, re-operation, and re-hospitalizations). The secondary objective of this study will be to evaluate whether utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs only).
Interventions
- OTHER 3D printed plastic model prototype
- OTHER 3D CT scan
- OTHER Plain film radiographs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-09 |
| Est. Completion | 2020-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02845245
The ClinicalTrials.gov registry entry for NCT02845245 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 3D printed plastic model prototype is the first listed.
NCT02845245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02845245 about?
NCT02845245 is a clinical study titled "Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques". Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of high-energy trauma such as motor vehicle collisions or fall from a height. They are complex injuries often associated with significant fragment displacement and severe soft tissue injury, a combination that has ...
What is the current status of trial NCT02845245?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2016-09. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02845245?
The interventions under investigation include: 3D printed plastic model prototype (OTHER), 3D CT scan (OTHER), Plain film radiographs (OTHER).
Who is sponsoring clinical trial NCT02845245?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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