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NCT01415908 · ClinicalTrials.gov registry record · Phase 3
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
A Phase 3 study, sponsored by Medtronic Spinal and Biologics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT01415908: Clinical Trial Phase 3 study, sponsored by Medtronic Spinal and Biologics.
NCT01415908 is a Phase 3 study that was terminated before completion, run by Medtronic Spinal and Biologics. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01415908, a Phase 3 study, was terminated before completion, sponsored by Medtronic Spinal and Biologics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.
Primary Outcome
Rate of overall success is reported as percent of subjects who met all of the following criteria: 1. fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion); 2. pain/disability (Oswestry Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure."
Interventions
- DEVICE INFUSE Bone Graft
- OTHER Iliac Crest Bone Graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
Why NCT01415908 stopped before completion
NCT01415908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which INFUSE Bone Graft is the first listed.
NCT01415908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01415908 about?
NCT01415908 is a clinical study titled "INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine". This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with ...
What is the current status of trial NCT01415908?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2011-07. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01415908?
The interventions under investigation include: INFUSE Bone Graft (DEVICE), Iliac Crest Bone Graft (OTHER).
Who is sponsoring clinical trial NCT01415908?
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 NCT01415908's enrollment target sits among peer trials
15 1977th of 2000 higher than 18 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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