Trials / Completed
CompletedNCT01714804
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- SeaSpine, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient cohort.
Detailed description
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion in comparison to a retrospective cohort of Infuse subjects. Infuse subjects were not enrolled in the current study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Accell Evo3 Prospective Use |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2016-07-01
- Completion
- 2016-10-01
- First posted
- 2012-10-26
- Last updated
- 2018-01-23
- Results posted
- 2017-12-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01714804. Inclusion in this directory is not an endorsement.