N/A N=43 Treatment

Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion

Stenosis · Spondylosis · Degenerative Changes

Bottom Line

View on ClinicalTrials.gov: NCT01430299 ↗

Enrolled (actual)

Serious AEs

21.6%

Results posted

Feb 2018

Primary outcome: Primary: Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery — 43; 74 radiographic assessments

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Demineralized Bone Matrix (Device); rh-BMP2 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SeaSpine, Inc.
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery	43; 74	—

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.

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

View full record on ClinicalTrials.gov →

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.