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

This study has been completed.
Information provided by (Responsible Party):
SeaSpine, Inc. Identifier:
First received: August 30, 2011
Last updated: October 12, 2016
Last verified: October 2016
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
Degenerative Changes
Device: Integra Accell Evo3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Posterolateral fusion by radiographic assessment at 6 and 24 months post surgery [ Time Frame: 6 months and 24 months ] [ Designated as safety issue: Yes ]
  • Interbody fusion by radiographic assessment at 6 months, 12 months and 24 months post surgery [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Medical Outcomes [ Time Frame: Baseline, 6 weeks, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    SF-12v2, Oswestry Disability Index, Leg and Back Pain (VAS)

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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01430299

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

Responsible Party: SeaSpine, Inc. Identifier: NCT01430299     History of Changes
Other Study ID Numbers: ACC3-US-2010-1 
Study First Received: August 30, 2011
Last Updated: October 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on October 26, 2016