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

This study is currently recruiting participants.
Verified December 2013 by Integra LifeSciences Corporation
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01430299
First received: August 30, 2011
Last updated: December 17, 2013
Last verified: December 2013
  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: Allocation: Non-Randomized
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 Integra LifeSciences Corporation:

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 ]

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Accell Evo3 Device: Integra Accell Evo3
Prospective use Integra Accell Evo3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430299

Contacts
Contact: Andrew Tummon andrew.tummon@integralife.com

Locations
United States, California
University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery Recruiting
Sacramento, California, United States, 95816
Contact: Abhijeet Gorhe    916-734-3093    abhijeet.gorhe@ucdmc.ucdavis.edu   
Principal Investigator: Eric Klineberg, MD         
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Principal Investigator: Eric Klineberg, M.D. University of CA - Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01430299     History of Changes
Other Study ID Numbers: ACC3-US-2010-1
Study First Received: August 30, 2011
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Spondylosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014