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

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ClinicalTrials.gov Identifier: NCT01430299
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : February 28, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stenosis Spondylosis Degenerative Changes Device: Demineralized Bone Matrix Device: rh-BMP2 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion
Study Start Date : June 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
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 Name: Accell Evo3

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 Name: Infuse




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430299


Locations
United States, California
University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Sacramento, California, United States, 95816
Sponsors and Collaborators
SeaSpine, Inc.
Investigators
Principal Investigator: Eric Klineberg, M.D. University of CA - Davis

Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT01430299     History of Changes
Other Study ID Numbers: ACC3-US-2010-1
First Posted: September 8, 2011    Key Record Dates
Results First Posted: February 28, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases