N/A
Completed N=43
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
Stenosis · Spondylosis · Degenerative Changes
Source: ClinicalTrials.gov NCT01430299 ↗
Enrolled (actual)
43
Serious AEs
21.6%
Results posted
Feb 2018
Primary outcomePrimary: Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery — 43; 74 radiographic assessments
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery |
43; 74 | — |
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
Data sourced from ClinicalTrials.gov (NCT01430299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.