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

Stenosis Clinical Trial

Official title:

Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430299
• Other study ID #: ACC3-US-2010-1
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: October 2016

Study information

• Verified date: May 2018
• Source: SeaSpine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Changes
• Spondylosis
• Stenosis

Intervention

Device:
• Demineralized Bone Matrix
Accell Evo3 in posteriolateral fusion (prospective cohort)
• rh-BMP2
rh-BMP2 in posterolateral fusion (retrospective cohort)

Locations

Country	Name	City	State
United States	University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
SeaSpine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery	Posterolateral fusion by radiographic assessment 12 months post surgery	12 months