A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

• Sponsor: Globus Medical Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02184520
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Instabilities Thoracic, Lumbar and Sacral Spine; Chronic Instabilities Thoracic, Lumbar and Sacral Spine; Deformities of the Thoracic, Lumbar and Sacral Spine	Device: TRANSITION; Device: REVERE	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
• Actual Study Start Date: Apr 19, 2016
• Actual Primary Completion Date: Oct 20, 2016
• Actual Study Completion Date: May 18, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fusion Rates [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fort Wayne Orthopaedics	Fort Wayne	Indiana	United States	46804

Sponsors and Collaborators

• Globus Medical Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Globus Medical Inc
• ClinicalTrials.gov Identifier: NCT02184520
• Other Study ID Numbers: PS090007/A10
• First Posted: Jul 9, 2014
• Last Update Posted: Mar 15, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Aneurysm, Dissecting; Congenital Abnormalities

Study Results

Participant Flow

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

Arm/Group Title	TRANSITION	REVERE
Arm/Group Description	Stabilization System TRANSITION	Stabilization System REVERE
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	TRANSITION	REVERE	Total
Arm/Group Description	Stabilization System TRANSITION	Stabilization System REVERE	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Race (NIH/OMB) () []
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	TRANSITION	REVERE
Arm/Group Description	Stabilization System TRANSITION	Stabilization System REVERE
Measure Participants	0	0

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
Arm/Group Title	TRANSITION		REVERE
Arm/Group Description	Stabilization System		Stabilization System
All Cause Mortality
	TRANSITION		REVERE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	TRANSITION		REVERE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	TRANSITION		REVERE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.