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Completed

NCT Number: NCT01430299

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

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.

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Key information

Conditions

Stenosis Bone Diseases Constriction, Pathologic Degenerative Changes Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Demineralized Bone Matrix

Device

Accell Evo3 in posteriolateral fusion (prospective cohort)

Other names: Accell Evo3

rh-BMP2

Device

rh-BMP2 in posterolateral fusion (retrospective cohort)

Other names: Infuse

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

SeaSpine, Inc.

Industry

Registry information

Official study title

Efficacy and Safety of Integra Accell Evo3 Demineralized Bone Matrix Instrumented Posterolateral Lumbar Spine Fusion

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2011
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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