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OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

NCT01873586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-06-17

Study results available
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Summary

The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.

Conditions

  • Degenerative Changes
  • Stenosis
  • Spondylosis

Interventions

PROCEDURE

Posterolateral Fusion

Sponsors & Collaborators

  • SeaSpine, Inc.

    lead INDUSTRY

Principal Investigators

  • Ross Sherban, DO · Sherban Orthopaedic and Spine Surgery, PLLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

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 NCT01873586 on ClinicalTrials.gov