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NCT01016067 · ClinicalTrials.gov registry record · Phase 3
Tibial Delayed Healing Pivotal Clinical Trial
A Phase 3 study, sponsored by Medtronic Spinal and Biologics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT01016067: Clinical Trial Phase 3 study, sponsored by Medtronic Spinal and Biologics.
NCT01016067 is a Phase 3 study that was terminated before completion, run by Medtronic Spinal and Biologics. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01016067, a Phase 3 study, was terminated before completion, sponsored by Medtronic Spinal and Biologics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
Primary Outcome
Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as "implant-associated" or "implant/surgical procedure-associated" (device-related); 5.no additional surgical procedures classified as a failure.
Interventions
- PROCEDURE Autograft bone
- DEVICE INFUSE/MASTERGRAFT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
Why NCT01016067 stopped before completion
NCT01016067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Autograft bone is the first listed.
NCT01016067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01016067 about?
NCT01016067 is a clinical study titled "Tibial Delayed Healing Pivotal Clinical Trial". Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
What is the current status of trial NCT01016067?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2010-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01016067?
The interventions under investigation include: Autograft bone (PROCEDURE), INFUSE/MASTERGRAFT (DEVICE).
Who is sponsoring clinical trial NCT01016067?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01016067's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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