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A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

NCT02184520 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-03-15

Study results available
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Summary

This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.

Conditions

  • Acute Instabilities Thoracic, Lumbar and Sacral Spine
  • Chronic Instabilities Thoracic, Lumbar and Sacral Spine
  • Deformities of the Thoracic, Lumbar and Sacral Spine

Interventions

DEVICE

TRANSITION

DEVICE

REVERE

Sponsors & Collaborators

  • Globus Medical Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-19
Primary Completion
2016-10-20
Completion
2017-05-18

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 NCT02184520 on ClinicalTrials.gov