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

May 7, 2018 updated by: SeaSpine, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Demineralized Bone Matrix
a prospective cohort of patients undergoing posterolateral lumbar fusion with Evo3 in the posterolateral space
Device: Demineralized Bone Matrix
Accell Evo3 in posteriolateral fusion (prospective cohort)
Other Names:
  • Accell Evo3
OTHER: 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
Device: rh-BMP2
rh-BMP2 in posterolateral fusion (retrospective cohort)
Other Names:
  • Infuse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery
Time Frame: 12 months
Posterolateral fusion by radiographic assessment 12 months post surgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SeaSpine, Inc.

Investigators

  • Principal Investigator: Eric Klineberg, M.D., University of CA - Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (ESTIMATE)

September 8, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACC3-US-2010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spondylosis

Clinical Trials on Demineralized Bone Matrix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe