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

SeaSpine

Status: Completed

Conditions: Degenerative Changes; Spondylosis; Stenosis

Treatments: Device: rh-BMP2; Device: Demineralized Bone Matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430299

ACC3-US-2010-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Demineralized Bone Matrix

Other group

Description:

a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space

Treatment:

Device: Demineralized Bone Matrix

rh-BMP2

Other group

Description:

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

Treatment:

Device: rh-BMP2