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A Prospective Study of the InterFuse T(tm),

NCT02678130 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-11-02

No results posted yet for this study

Summary

The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.

Conditions

  • Low Back Pain

Interventions

DEVICE

InterFuse T

Transforaminal Lumbar Interbody fusion (TLIF)

DEVICE

Standard of Care TLIF (Stryker AVS Unilif)

Transforaminal Lumbar Interbody Fusion (TLIF)

Sponsors & Collaborators

  • Vertebral Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen P Kallhorn, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-06-30
Completion
2019-01-31

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 NCT02678130 on ClinicalTrials.gov