Back to resultsEfficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
Primary Purpose
Stenosis, Spondylosis, Degenerative Changes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demineralized Bone Matrix
rh-BMP2
Sponsored by
About this trial
This is an interventional treatment trial for Stenosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Demineralized Bone Matrix
rh-BMP2
Arm Description
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
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
Outcomes
Primary Outcome Measures
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Posterolateral fusion by radiographic assessment 12 months post surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01430299
Brief Title
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
Official Title
Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SeaSpine, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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 posterolateral spine fusion with a retrospective comparison to a historical patient cohort. The historical patient cohort has not been previously published and therefore, no reference to this group can be provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis, Spondylosis, Degenerative Changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Demineralized Bone Matrix
Arm Type
Other
Arm Description
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
Arm Title
rh-BMP2
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Demineralized Bone Matrix
Other Intervention Name(s)
Accell Evo3
Intervention Description
Accell Evo3 in posteriolateral fusion (prospective cohort)
Intervention Type
Device
Intervention Name(s)
rh-BMP2
Other Intervention Name(s)
Infuse
Intervention Description
rh-BMP2 in posterolateral fusion (retrospective cohort)
Primary Outcome Measure Information:
Title
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Description
Posterolateral fusion by radiographic assessment 12 months post surgery
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Klineberg, M.D.
Organizational Affiliation
University of CA - Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
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