NCT02184520

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 19, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

July 3, 2014

Results QC Date

February 18, 2021

Last Update Submit

February 18, 2021

Conditions

Acute Instabilities Thoracic, Lumbar and Sacral SpineChronic Instabilities Thoracic, Lumbar and Sacral SpineDeformities of the Thoracic, Lumbar and Sacral Spine

Outcome Measures

Primary Outcomes (1)

  • Fusion Rates

    The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.

    24 months

Study Arms (2)

TRANSITION

ACTIVE COMPARATOR

Stabilization System

Device: TRANSITION

REVERE

ACTIVE COMPARATOR

Stabilization System

Device: REVERE

Interventions

TRANSITIONDEVICE
TRANSITION
REVEREDEVICE
REVERE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Results Point of Contact

Title
Jacqueline Myer
Organization
Globus Medical
jmyer@globusmedical.com
610-930-1800

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

April 19, 2016

Primary Completion

October 20, 2016

Study Completion

May 18, 2017

Last Updated

March 15, 2021

Results First Posted

March 15, 2021

Record last verified: 2021-02

Locations

US(1)