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rh-BMP2 for Spondylosis
N/A
Waitlist Available
Led By Eric Klineberg, M.D.
Research Sponsored by SeaSpine, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
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.
Eligible Conditions
- Spondylosis
- Degenerative Changes
- Stenosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Trial Design
2Treatment groups
Experimental Treatment
Group I: rh-BMP2Experimental Treatment1 Intervention
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
Group II: Demineralized Bone MatrixExperimental Treatment1 Intervention
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rh-BMP2
2011
N/A
~50
Demineralized Bone Matrix
2011
N/A
~50
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Who is running the clinical trial?
SeaSpine, Inc.Lead Sponsor
8 Previous Clinical Trials
2,484 Total Patients Enrolled
3 Trials studying Spondylosis
95 Patients Enrolled for Spondylosis
Eric Klineberg, M.D.Principal InvestigatorUniversity of CA - Davis
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