Trials / Active Not Recruiting
Active Not RecruitingNCT03118505
A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
A Prospective, Randomized, Multi-Center, Open-Label Pilot Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal Conditions
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain safety and effectiveness data on the investigational device for multi-level PLF procedures and determine the most appropriate rhBMP-2 dose for use in this indication. The study information may be used for a potential pivotal study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Infuse Bone Graft | Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation |
| DEVICE | Medtronic DBM | Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation |
Timeline
- Start date
- 2017-06-29
- Primary completion
- 2025-07-01
- Completion
- 2026-12-01
- First posted
- 2017-04-18
- Last updated
- 2026-01-13
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03118505. Inclusion in this directory is not an endorsement.