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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01430299
First received: August 30, 2011
Last updated: June 3, 2014
Last verified: June 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430299

Locations
United States, California
University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery
Sacramento, California, United States, 95816
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: June 3, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014