Acute Instabilities Thoracic, Lumbar and Sacral SpineNCT02184520

A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System

A study testing TRANSITION and REVERE in people with Acute Instabilities Thoracic, Lumbar and Sacral Spine and Chronic Instabilities Thoracic, Lumbar and Sacral Spine, run by Globus Medical Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
What is being tested?: TRANSITION and REVERE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 19 Apr 2016to 18 May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804

Other trials in United States

About this study

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
Being tested: TRANSITION, REVERE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRANSITIONDevice
REVEREDevice

Study groups in NCT02184520
Study group	Role	What they receive
TRANSITION	Active comparator	Stabilization System Receives: Device: TRANSITION
REVERE	Active comparator	Stabilization System Receives: Device: REVERE

What is being measured

The primary outcome is the main question the study is designed to answer.

Fusion Rates
The study was terminated prior to primary and secondary endpoint data collection, therefore no study data is reported.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 201618 May 2017

First posted9 Jul 2014 (estimated)
Study start19 Apr 2016
Primary completion20 Oct 2016
Study completion18 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Instabilities Thoracic, Lumbar and Sacral SpineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02184520
Sponsor's protocol ID: PS090007/A10
Status last verified: Feb 2021
First submitted: 3 Jul 2014
Last updated: 15 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
ClinicalTrials.gov ID: NCT02184520
Acronym / sponsor ID: PS090007/A10
Conditions: Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
Study type: Interventional
Recruitment status: Terminated
Enrolment: 1 participants (actual)
Lead sponsor: Globus Medical IncIndustry (pharma, biotech, devices)
Study start: 19 Apr 2016 (actual)
Primary completion: 20 Oct 2016 (actual)
Study completion: 18 May 2017 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Posted 15 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TRANSITION	Active comparator	Device: TRANSITIONStabilization System
REVERE	Active comparator	Device: REVEREStabilization System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRANSITION	Device	TRANSITION
REVERE	Device	REVERE

Primary outcome

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

Results and safety

Results posted to the registry on 15 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRANSITION	0	0
REVERE	0	0

Primary outcome: Fusion Rates

Time frame: 24 months

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

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRANSITION	0 of 0	0 of 0	0
REVERE	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fusion Rates (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.