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

NCT01430299 | Completed Results

• 1 other identifier: ACC3-US-2010-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis; Spondylosis; Degenerative Changes

Outcome Measures

Primary Outcomes (1)

• Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery

  Posterolateral fusion by radiographic assessment 12 months post surgery

  12 months

Study Arms (2)

Demineralized Bone Matrix

OTHER

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

Device: Demineralized Bone Matrix

rh-BMP2

OTHER

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

Device: rh-BMP2

Interventions

Demineralized Bone Matrix DEVICE

Accell Evo3 in posteriolateral fusion (prospective cohort)

Also known as: Accell Evo3

Demineralized Bone Matrix

rh-BMP2 DEVICE

rh-BMP2 in posterolateral fusion (retrospective cohort)

Also known as: Infuse

rh-BMP2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SeaSpine, Inc.: lead

Study Sites (1)

University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Spondylosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Vice President, Orthobiologics Research & Development
• Organization: SeaSpine

frank.vizesi@seaspine.com

760.216.5138

Study Officials

• Eric Klineberg, M.D.

  University of CA - Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 8, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 7, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-05

Locations

US (1)