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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: Clinical Trial NA study, sponsored by Inova Health Care Services.
NCT02845245 is a NA study that was terminated before completion, run by Inova Health Care Services. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Patients will self-report pain using a numeric pain rating scale (NPRS), 11-point numeric scale. 0 = No pain and 10 = Worst Possible Pain
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 |
Why NCT02845245 stopped before completion
NCT02845245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which 3D printed plastic model prototype is the first listed.
NCT02845245 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02845245's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 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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