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NCT03061279 · ClinicalTrials.gov registry record · NA
Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03061279: Clinical Trial NA study, sponsored by Stanford University.
NCT03061279 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 1 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
NCT03061279, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectives from this study 1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year,
Primary Outcome
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
Interventions
- DEVICE Fixation by Acutrak headless screw
- DEVICE Fixation by headed screws, plates, and or wires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2017-10-26 |
| Phase | NA |
Why NCT03061279 stopped before completion
NCT03061279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 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 Fixation by Acutrak headless screw is the first listed.
NCT03061279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061279 about?
NCT03061279 is a clinical study titled "Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures". The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectiv...
What is the current status of trial NCT03061279?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2017-04-01. Estimated completion is 2017-10-26.
What interventions are being tested in trial NCT03061279?
The interventions under investigation include: Fixation by Acutrak headless screw (DEVICE), Fixation by headed screws, plates, and or wires (DEVICE).
Who is sponsoring clinical trial NCT03061279?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061279's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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