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Assessment of nanOss Bioactive 3D in the Posterolateral Spine

NCT01829997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-04-17

Study results available
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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 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process.

nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D 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.

Conditions

  • Degenerative Disc Disease
  • Spinal Stenosis
  • Spondylolisthesis

Interventions

DEVICE

nanOss Bioactive 3D BVF

nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed.

Sponsors & Collaborators

  • Pioneer Surgical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Robbins, MD · Milwaukee Spinal Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2018-04-30
Completion
2018-04-30

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 NCT01829997 on ClinicalTrials.gov