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NCT02161016 · ClinicalTrials.gov registry record · Phase 4
A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
A Phase 4 study, sponsored by RTI Surgical.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT02161016: Clinical Trial Phase 4 study, sponsored by RTI Surgical.
NCT02161016 is a Phase 4 study that was terminated before completion, run by RTI Surgical. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02161016, a Phase 4 study, was terminated before completion, sponsored by RTI Surgical.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the baseline visit and examinations will be completed. Patients will be evaluated at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery.
Primary Outcome
The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.
Interventions
- DEVICE map3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
Why NCT02161016 stopped before completion
NCT02161016 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which map3 is the first listed.
NCT02161016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02161016 about?
NCT02161016 is a clinical study titled "A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft". This is a single arm pilot study in patients requiring surgical fusion in the foot or ankle. Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells. This cohort study will enroll 24 patients total at 1 site. After subjects have signed an informed consent, the ...
What is the current status of trial NCT02161016?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2014-06. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02161016?
The interventions under investigation include: map3 (DEVICE).
Who is sponsoring clinical trial NCT02161016?
This trial is sponsored by RTI Surgical, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02161016's enrollment target sits among peer trials
1 2000th of 2000 the lowest 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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