Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
NCT ID: NCT01430299
Last Updated: 2018-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2011-06-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Demineralized Bone Matrix
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
Demineralized Bone Matrix
Accell Evo3 in posteriolateral fusion (prospective cohort)
rh-BMP2
A retrospective cohort of patients who were age- and sex- matched to the prospective cohort who underwent posterolateral lumbar fusion with use of rh-BMP2
rh-BMP2
rh-BMP2 in posterolateral fusion (retrospective cohort)
Interventions
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Demineralized Bone Matrix
Accell Evo3 in posteriolateral fusion (prospective cohort)
rh-BMP2
rh-BMP2 in posterolateral fusion (retrospective cohort)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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SeaSpine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Klineberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of CA - Davis
Locations
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University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Sacramento, California, United States
Countries
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Other Identifiers
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ACC3-US-2010-1
Identifier Type: -
Identifier Source: org_study_id
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