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NCT01693367 · ClinicalTrials.gov registry record · Phase 4
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
A Phase 4 study, sponsored by AO Innovation Translation Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT01693367 is a Phase 4 study that was terminated before completion, run by AO Innovation Translation Center. The registered enrollment target is 5 participants.
The verdict
NCT01693367, a Phase 4 study, was terminated before completion, sponsored by AO Innovation Translation Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
Interventions
- DEVICE DLS 5.0 (Dynamic locking screws)
- DEVICE SLS (Standard locking screw)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01693367
The ClinicalTrials.gov registry entry for NCT01693367 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AO Innovation Translation Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DLS 5.0 (Dynamic locking screws) is the first listed.
NCT01693367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01693367 about?
NCT01693367 is a clinical study titled "Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation". The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased a...
What is the current status of trial NCT01693367?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2012-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01693367?
The interventions under investigation include: DLS 5.0 (Dynamic locking screws) (DEVICE), SLS (Standard locking screw) (DEVICE).
Who is sponsoring clinical trial NCT01693367?
This trial is sponsored by AO Innovation Translation Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
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