MedTrace Logo

Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

NCT02317185 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2018-04-19

No results posted yet for this study

Summary

The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Stenosis

Interventions

DEVICE

genex bone graft with bone graft

OTHER

autogenous bone graft

Sponsors & Collaborators

  • Spine Wave

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02317185 on ClinicalTrials.gov