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Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions

NCT01452516 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-12-07

No results posted yet for this study

Summary

Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive can be mixed with bone marrow aspirate (BMA) and other graft materials to obtain new bone growth during the healing process.

It is hypothesized that the use of nanOss Bioactive will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion. In addition, patients are expected to see an improvement in Oswestry Disability Index scores, VAS pain scores, and SF36 scores, while decreasing the use of pain medication, returning to work, and finding satisfaction in the results of their surgery.

Conditions

  • Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis

Interventions

DEVICE

nanOss Bioactive Bone void filler

Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler

DEVICE

Interbody FCage

Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion

Sponsors & Collaborators

  • Pioneer Surgical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Mathew Songer, MD · Advanced Center for Orthopedics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452516 on ClinicalTrials.gov