INDEPENDENCE Spacer for Lumbar Fusion

NCT02299323 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2016-08-10

No results posted yet for this study

Summary

The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

INDEPENDENCE

Lumbar Integrated plate and spacer, with percutaneous screws and rods.

Sponsors & Collaborators

  • Globus Medical Inc

    lead INDUSTRY

Principal Investigators

  • Christopher Chaput, MD · Scott & White Healthcare

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

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 NCT02299323 on ClinicalTrials.gov