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Efficacy and Safety of Accell Evo3 DBM in Instrumented Posterolateral Lumbar Spine Fusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430299
First Posted: September 8, 2011
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SeaSpine, Inc.
  Purpose
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 Intervention
Stenosis Spondylosis Degenerative Changes Device: Integra Accell Evo3

Study Type: Interventional
Study Design: Intervention Model: Single Group 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

Further study details as provided by SeaSpine, Inc.:

Primary Outcome Measures:
  • Posterolateral fusion by radiographic assessment 12 months post surgery [ Time Frame: 12 months ]
    Posterolateral fusion by radiographic assessment 12 months post surgery


Secondary Outcome Measures:
  • Posterolateral fusion by radiographic assessment at 6 and 24 months post surgery [ Time Frame: 6 months and 24 months ]
    Posterolateral fusion by radiographic assessment at 6 and 24 months post surgery

  • Interbody fusion by radiographic assessment at 6 months, 12 months and 24 months post surgery [ Time Frame: 6, 12 and 24 months ]
    Interbody fusion by radiographic assessment at 6 months, 12 months and 24 months post surgery

  • Medical Outcomes [ Time Frame: Baseline, 6 weeks, 3, 6, 12 and 24 months ]
    SF-12v2, Oswestry Disability Index, Leg and Back Pain (VAS)

  • Complication Rates [ Time Frame: Surgery (baseline), 6 weeks, 3, 6, 12 and 24 months ]
    Complication Rates


Enrollment: 55
Study Start Date: June 2011
Study Completion Date: October 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Accell Evo3 Device: Integra Accell Evo3
Prospective use Integra Accell Evo3

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 TLIF, PLF or 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
  Contacts and Locations
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
  More Information

Responsible Party: SeaSpine, Inc.
ClinicalTrials.gov Identifier: NCT01430299     History of Changes
Other Study ID Numbers: ACC3-US-2010-1
First Submitted: August 30, 2011
First Posted: September 8, 2011
Last Update Posted: April 25, 2017
Last Verified: April 2017

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