A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

February 18, 2021 updated by: Globus Medical Inc
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any of the following acute or chronic instabilities or deformities of the thoracic, lumbar or sacral spine:
  • degenerative spondylolisthesis with objective evidence of neurologic impairment,
  • kyphosis, or
  • pseudoarthrosis (failed previous fusion)
  • Age 18 or older at the time of consent
  • Able to understand and sign informed consent form
  • Psychosocially, mentally and physically able to comply with protocol
  • Able to meet the proposed follow-up schedule at 6 mo, 12 mo, and 24 mo

Exclusion Criteria:

  • Prior fusion surgery or another spinal device implanted in the thoracic, lumbar or sacral spine
  • Requires treatment of more than two vertebral levels
  • Lytic spondylolisthesis at the index level(s)
  • Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
  • Sustained pathologic fractures of the spine or hip, including prior fracture or trauma to vertebral structures at any thoracic, lumbar, or sacral level
  • Morbid obesity defined as a body mass index > 40, or a weight more than 100 lbs over ideal body weight
  • Pregnant or interested in becoming pregnant within the next 2 years
  • Active systemic or local infection
  • Known allergy to device materials titanium, polycarbonate (PCU), polyethylene terepthalate (PET), or hydroxyapatite (HA).
  • Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids, excluding routine NSAIDs)
  • Systemic disease including AIDS, HIV, Hepatitis C
  • Has an active malignancy defined as a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
  • Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
  • Participation in an investigational device or drug clinical trials within 30 days of surgery
  • Acute mental illness or substance abuse
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TRANSITION
Stabilization System
Device: TRANSITION
Active Comparator: REVERE
Stabilization System
Device: REVERE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion Rates
Time Frame: 24 months
The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Globus Medical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2016

Primary Completion (Actual)

October 20, 2016

Study Completion (Actual)

May 18, 2017

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS090007/A10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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