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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: Clinical Trial Phase 4 study, sponsored by AO Innovation Translation Center.
NCT01693367 is a Phase 4 study that was terminated before completion, run by AO Innovation Translation Center. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess pain, stiffness, and physical function
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 |
Why NCT01693367 stopped before completion
NCT01693367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which DLS 5.0 (Dynamic locking screws) is the first listed.
NCT01693367 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01693367's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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