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

Not Applicable

Completed

• Conditions: Stenosis; Degenerative Changes; Spondylosis
• Interventions: Device: Demineralized Bone Matrix; Device: rh-BMP2

• Registration Number: NCT01430299
• Lead Sponsor: SeaSpine, Inc.

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Primary Completion: 2016-03
• Study Completion: 2016-10
• Results First Submitted: 2018-01-04
• Results First Submitted QC: 2018-01-31
• Results First Posted: 2018-02-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Demineralized Bone Matrix	Demineralized Bone Matrix	a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
rh-BMP2	rh-BMP2	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

Primary Outcome Measures

Name	Time	Method
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery	12 months	Posterolateral fusion by radiographic assessment 12 months post surgery

Trial Locations

Locations (1)

University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery; 🇺🇸 Sacramento, California, United States