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NCT03257540 · ClinicalTrials.gov registry record
Early Weight-Bearing After Lapidus Arthrodesis
A clinical trial, sponsored by Paragon 28.
- Terminated
- Registry status
- 8
- Enrollment target
NCT03257540: Clinical Trial study, sponsored by Paragon 28.
NCT03257540 is a clinical trial that was terminated before completion, run by Paragon 28. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03257540 was terminated before completion, sponsored by Paragon 28.
- TERMINATED
- Registry status
- 8 participants
- Enrollment target
Study Summary
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing protocol will be non-inferior to union rates previously published for this procedure.
Primary Outcome
Evaluate clinical/radiographic healing (union vs. non-union) after a Lapidus arthrodesis procedure at 6 months following a surgery using the Phantom Intramedullary nail with early weightbearing at 2 weeks.
Interventions
- DEVICE Small Bone Intramedullary Nail
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2018-08-31 |
Why NCT03257540 stopped before completion
NCT03257540 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Small Bone Intramedullary Nail is the first listed.
NCT03257540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03257540 about?
NCT03257540 is a clinical study titled "Early Weight-Bearing After Lapidus Arthrodesis". The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail. The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis procedure with the Phantom™ Intramedullary Na...
What is the current status of trial NCT03257540?
This trial is currently terminated. The enrollment target is 8 participants. The study started on 2017-10-31. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT03257540?
The interventions under investigation include: Small Bone Intramedullary Nail (DEVICE).
Who is sponsoring clinical trial NCT03257540?
This trial is sponsored by Paragon 28, which has 7 total clinical trials registered on ClinicalTrials.gov.
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