At a glance
ClinicalIndex Comparison RecordN/ACompleted· 43 enrolled
Drug / intervention
Demineralized Bone Matrix +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion
In Brief
A clinical study evaluating Demineralized Bone Matrix and rh-BMP2 for Stenosis and 2 related conditions. Completed, enrolled 43 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStenosis, Spondylosis, Degenerative Changes
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedSep 2011
Primary CompletionMar 2016
Study CompletionOct 2016
TodayJul 2026
First PostedSep 8, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.8 years ago
Interventions
Demineralized Bone Matrixdevice
Accell Evo3 in posteriolateral fusion (prospective cohort)
rh-BMP2device
rh-BMP2 in posterolateral fusion (retrospective cohort)