Status:
COMPLETED
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
Lead Sponsor:
SeaSpine, Inc.
Conditions:
Stenosis
Spondylosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison ...
Detailed Description
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison ...
Eligibility Criteria
Inclusion
- Age 18 years of age or older at the time of surgery
- Require spinal fusion using posterior Transforaminal Lumbar Interbody Fusion (TLIF), Posterolateral Fusion (PLF) or Posterior Lumber Interbody Fusion (PLIF) in 1 to 3 levels between L3-S1
- Follow-up radiographic imaging post surgery
Exclusion
- Long term users of medications known to inhibit fusion,bone metabolism or epidural steroid injections
- Immunosuppressive agents, Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs, Growth Factors or Insulin
- Treated with radiotherapy since their surgery
- Medical conditions known to impact bone metabolism, such as Paget's disease, osteoporosis
- Pregnant or lactating women or women wishing to become pregnant
- Prisoner
- Participating in an investigational drug or another device study
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01430299
Start Date
June 1 2011
End Date
October 1 2016
Last Update
June 7 2018
Active Locations (1)
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1
University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Sacramento, California, United States, 95816