Disc DegenerationNCT05315375

Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages

An observational study of Disc Degeneration, run by Centre de l'arthrose, Paris.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

INTRODUCTION The expandable cage technology is not new, but several questions remain under-studied. Among them, there are the sagittal balance, the subsidence and the adjacent disc degeneration. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Disc Degeneration
What is being tested?: corpectomy
Type of treatment: Medical device
How many people: 27 participants
Where: No sites listed yet
Study dates: 2 Jan 2010to 30 Mar 2022
Phase: Observational
Are there results?: None posted in the registry

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

Study population: All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Who may be able to join

All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Who cannot join

About this study

Official title: Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages: Comprehensive Long-term Follow-up Outcomes

INTRODUCTION

The expandable cage technology is not new, but several questions remain under-studied. Among them, there are the sagittal balance, the subsidence and the adjacent disc degeneration. Moreover, assessment of the correction and kyphosis regardless of the physiological angles can possibly lead to calculation bias.

The objective of this study was to assess the extent to which the functional outcomes were correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral body reconstruction with expandable cages for trauma.

MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its association with other variables was sought. The local kyphosis and the regional traumatic angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc degeneration (using the UCLA grading score) were quantified. Bone quality was assessed through the Hounsfield Unit of the vertebral body.

Conditions: Disc Degeneration
Being tested: corpectomy
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

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

corpectomyDevice
vertebral corpectomy using expandable cage

Study groups in NCT05315375
Study group	Role	What they receive
Corpectomy		surgical procedure using expandable cage Receives: Device: corpectomy

What is being measured

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

Oswestry Disability Index (ODI)
specific lumbar surgery score
Measured: 4 years

Timeline

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

2 Jan 201030 Mar 2022

First posted7 Apr 2022
Study start2 Jan 2010
Primary completion31 Dec 2017
Study completion30 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Disc DegenerationStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05315375
Sponsor's protocol ID: vlift
Status last verified: Mar 2022
First submitted: 30 Mar 2022
Last updated: 7 Apr 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

All Disc Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages: Comprehensive Long-term Follow-up Outcomes
ClinicalTrials.gov ID: NCT05315375
Acronym / sponsor ID: vlift
Conditions: Disc Degeneration
Study type: Observational
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Centre de l'arthrose, ParisUniversity, hospital or other
Study start: 2 Jan 2010 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 30 Mar 2022 (actual)
First posted: 7 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

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

INTRODUCTION

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Corpectomy	–	Device: corpectomysurgical procedure using expandable cage

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Key inclusion criteria (1 listed)

All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Key exclusion criteria (1 listed)

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
corpectomyvertebral corpectomy using expandable cage	Device	Corpectomy

Primary outcome

Oswestry Disability Index (ODI)
Time frame: 4 years
specific lumbar surgery score

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Individual participant dataSharing planned: No

Related trials for Disc Degeneration

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

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.

cedric maillot study director

APHP

Questions about this trial

What is this clinical trial studying?

An observational study of Disc Degeneration, run by Centre de l'arthrose, Paris.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Oswestry Disability Index (ODI) (time frame: 4 years). 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 NCT05315375.

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 7 Apr 2022.