Degenerative Disc DiseaseMaverickNCT01338493

Maverick Total Disc Replacement in a 'Real World' Patient Population

An observational study of Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 13 sites in 3 countries.

Completed

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

Trial summary

The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement. Read more about this study

Who is it for?: Any age
Conditions the study is for: Degenerative Disc Disease
What is being tested?: lumbar spinal arthroplasty + Maverick™
Type of treatment: Surgery or procedure
How many people: 139 participants
Where: 13 sitesin 3 countries
Study dates: Feb 2009to Jul 2013
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patient eligibility is determined according to labeling

Who may be able to join

Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
Foraminal stenosis due to loss of disc height
Back pain and/or leg pain.

Who cannot join

Spondylolisthesis at the affected or adjacent level
Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy
Obesity
Osteoporosis
Metallic allergy to cobalt-chromium-molybdenum alloys
Psychosis

Show all 20Show fewer

Infection
Spinal canal stenosis
Overlying thoracolumbar kyphosis
Systemic infection or infection at the site of surgery
Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
Diseases of bone metabolism
Pregnancy
Signs of local inflammation
Fever or Leukocytosis
Grossly distorted anatomy caused by congenital abnormalities
Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level)
Any case where the implants or components selected would be too large or too small to achieve a successful result
Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
Any patient unwilling to follow postoperative instructions.

Trial locations and contacts

13 sites in 3 countries.

Country

City, postcode or hospital

13 sites in 3 countries

France9 sites

CHU Pellegrin Tripode
Bordeaux, 33076
CH Antoine Béclère - Service de Chirurgie Orthopédique
Clamart, 92141
Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon
Clichy, 92110
Clinique de Neurochirurgie Hôpital Roger Salengro
Lille, 59037
CH La Timone
Marseille, 13385
CH de Meulan - Service de Chirurgie Orthopédique
Meulan-en-Yvelines, 78250
Service de Neurochirurgie Hôpital Nice
Nice, 06300
CH Lariboisière, Service de Neurochirurgie
Paris, 75010
Clinique du Cours Dillon
Toulouse, 31300

Other trials in France

Germany3 sites

Charité Berlin - Klinik für Orthopädie
Berlin, 10117
Universitätsklinikum Magdeburg
Magdeburg, 39120
Praxis für Orthopädie und Neurochirurgie Potsdam
Potsdam, 14482

Other trials in Germany

Canada1 site

Montreal General Hospital
Québec, H3G1A4

Other trials in Canada

About this study

Official title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study

The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

Conditions: Degenerative Disc Disease
Being tested: lumbar spinal arthroplasty + Maverick™
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.

lumbar spinal arthroplasty + Maverick™Procedure or surgery
All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.

Study groups in NCT01338493
Study group	Role	What they receive
lumbar spinal arthroplasty + Maverick™		Patients requiring total disc replacement Receives: Procedure: lumbar spinal arthroplasty + Maverick™

What is being measured

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

Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Measured: 6 months

Secondary outcomes (1)

Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.
0 = no pain, 10 = worst possible pain
Measured: 6 months

Timeline

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

Feb 2009Jul 2013

First posted19 Apr 2011 (estimated)
Study startFeb 2009
Primary completionJul 2013
Study completionJul 2013

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 Degenerative Disc DiseaseStudies 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: Case only
Time perspective: Prospective
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01338493
Sponsor's protocol ID: Maverick Global Registry
Acronym: Maverick
Status last verified: Jan 2016
First submitted: 17 Feb 2011
Last updated: 28 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study
ClinicalTrials.gov ID: NCT01338493
Acronym / sponsor ID: Maverick / Maverick Global Registry
Conditions: Degenerative Disc Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 19 Apr 2011 (estimated)
Results: Posted 18 Nov 2014

Clinical summary

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

The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
lumbar spinal arthroplasty + Maverick™	–	Procedure: lumbar spinal arthroplasty + Maverick™Patients requiring total disc replacement

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patient eligibility is determined according to labeling

Key inclusion criteria (3 listed)

Degenerative Disc Disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
Foraminal stenosis due to loss of disc height
Back pain and/or leg pain.

Key exclusion criteria (20 listed)

Spondylolisthesis at the affected or adjacent level
Posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy
Obesity
Osteoporosis
Metallic allergy to cobalt-chromium-molybdenum alloys

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
lumbar spinal arthroplasty + Maverick™All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.	Procedure or surgery	lumbar spinal arthroplasty + Maverick™

Primary outcome

Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
Time frame: 6 months
The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.

1 secondary outcome

Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
Time frame: 6 months

Results and safety

Results posted to the registry on 18 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumbar Spinal Arthroplasty + Maverick™	139	134

Primary outcome: Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)

Time frame: 6 months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Lumbar Spinal Arthroplasty + Maverick™ n = 122
Value	-25.4 (-29.0 to -21.9)

Lumbar Spinal Arthroplasty + Maverick™: p <0.0001, t-test, 2 sided

Population analysed: Reduction of disability was calculated for patients having available data at both baseline and 6 months.

1 secondary outcome is reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Lumbar Spinal Arthroplasty + Maverick™	57 of 134 (42.5%)	0 of 134 (0%)	Not reported

Limitations and caveats (from the sponsor): Seriousness of AEs was not assessed when the data were collected so it is not possible to separate SAEs and Other (Non-serious) AEs for the Maverick Registry. All events are here-reported as SAEs.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

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.

Jean-Charles Le Huec, Prof. principal investigator

CHU Pellegrin Tripode

13 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, run by Medtronic Spinal and Biologics at 13 sites in 3 countries.

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 3 inclusion and 20 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Germany, Canada. 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 18 Nov 2014). 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?

Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) (time frame: 6 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 NCT01338493.

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 28 Jan 2016.