Back to resultsA Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Primary Purpose
Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRANSITION
REVERE
Sponsored by
About this trial
This is an interventional treatment trial for Acute Instabilities Thoracic, Lumbar and Sacral Spine
Eligibility Criteria
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
Sites / Locations
- Fort Wayne Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TRANSITION
REVERE
Arm Description
Stabilization System
Stabilization System
Outcomes
Primary Outcome Measures
Fusion Rates
The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184520
Brief Title
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Official Title
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Study Start Date
April 19, 2016 (Actual)
Primary Completion Date
October 20, 2016 (Actual)
Study Completion Date
May 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Globus Medical Inc
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRANSITION
Arm Type
Active Comparator
Arm Description
Stabilization System
Arm Title
REVERE
Arm Type
Active Comparator
Arm Description
Stabilization System
Intervention Type
Device
Intervention Name(s)
TRANSITION
Intervention Type
Device
Intervention Name(s)
REVERE
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fort Wayne Orthopaedics
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
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