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CompletedNCT01338493MaverickUpdated Jan 28, 2016Results posted

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

An observational study in Degenerative Disc Disease, sponsored by Medtronic Spinal and Biologics. Completed at 13 sites in 3 countries. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Medtronic Spinal and Biologics · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
139
Sex
All
01

Study 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.

02

Conditions studied

  • Degenerative Disc Disease
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 139 is above the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Medtronic Spinal and Biologics is the lead sponsor of 56 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient eligibility is determined according to labeling

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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
  • 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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
139 participants (actual)

Groups and cohorts

  • lumbar spinal arthroplasty + Maverick™

    Patients requiring total disc replacement

    Procedure: lumbar spinal arthroplasty + Maverick™

Interventions

  • Procedurelumbar 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.

06

What researchers measure

Primary outcomes

  1. 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'.

    Time frame: 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

    Time frame: 6 months

07

Results

Posted Nov 18, 2014
Limitations and caveats
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.

Participant flow

Enrolled
Participant flow — Enrolled
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started139
Completed134
Not completed5
Withdrew: Withdrawal by subject1
Withdrew: Patient not implanted4
Implant
Participant flow — Implant
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started134
Completed134
Not completed0
Discharge
Participant flow — Discharge
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started134
Completed132
Not completed2
Withdrew: Death1
Withdrew: Missed visit1
6 Months Follow up
Participant flow — 6 Months Follow up
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started132
Completed113
Not completed19
Withdrew: Lost to follow-up11
Withdrew: Missed visit8
12 Months Follow up
Participant flow — 12 Months Follow up
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started113
Completed104
Not completed9
Withdrew: Lost to follow-up9
24 Months Follow up
Participant flow — 24 Months Follow up
MilestoneLumbar Spinal Arthroplasty + Maverick™
Started104
Completed104
Not completed0

Outcome measures

PrimaryReduction 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'.

Time frame:
6 months
Reported as:
Mean · units on a scale
Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
units on a scaleLumbar Spinal Arthroplasty + Maverick™
Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)-25.4 (-29.0 to -21.9)
Statistical analysis
  • Lumbar Spinal Arthroplasty + Maverick™ · t-test, 2 sided · p = <0.0001
SecondaryRelief 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

Time frame:
6 months
Reported as:
Mean · units on a scale
Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
units on a scaleLumbar Spinal Arthroplasty + Maverick™
Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)-4.0 (-4.5 to -3.4)
Statistical analysis
  • Lumbar Spinal Arthroplasty + Maverick™ · t-test, 2 sided · p = <0.0001

Adverse events

Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lumbar Spinal Arthroplasty + Maverick™—57/134 (42.5%)0/134 (0%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventLumbar Spinal Arthroplasty + Maverick™
Other eventsGeneral disorders24/134
Neurologic - Access-relatedNervous system disorders12/134
Neurologic - Late radiculopathy (not access-related)Nervous system disorders12/134
Abdominal wall relatedGeneral disorders9/134
Late non-specific low BPGeneral disorders6/134
Visceral - Genito-Urinary tractGeneral disorders5/134
Early non-specific low BPGeneral disorders5/134
VascularVascular disorders3/134
Visceral - Bowel or PeritoneumGeneral disorders1/134
Subsidence / ImpactionMusculoskeletal and connective tissue disorders1/134

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lumbar Spinal Arthroplasty + Maverick™
Mean43 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Lumbar Spinal Arthroplasty + Maverick™
Female70
Male64
Region of Enrollment
Region of Enrollment(participants)Lumbar Spinal Arthroplasty + Maverick™
France79
Canada5
Germany50
08

Study locations

13 sites
  • Montreal General Hospital
    Quebec, H3G1A4, Canada
  • CHU Pellegrin Tripode
    Bordeaux, 33076, France
  • CH Antoine Béclère - Service de Chirurgie Orthopédique
    Clamart, 92141, France
  • Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon
    Clichy, 92110, France
  • Clinique de Neurochirurgie Hôpital Roger Salengro
    Lille Cedex, 59037, France
  • CH La Timone
    Marseille, 13385, France
  • CH de Meulan - Service de Chirurgie Orthopédique
    Meulan, 78250, France
  • Service de Neurochirurgie Hôpital Nice
    Nice, 06300, France
  • CH Lariboisière, Service de Neurochirurgie
    Paris, 75010, France
  • Clinique du Cours Dillon
    Toulouse, 31300, France
  • Charité Berlin - Klinik für Orthopädie
    Berlin, 10117, Germany
  • Universitätsklinikum Magdeburg
    Magdeburg, 39120, Germany
  • Praxis für Orthopädie und Neurochirurgie Potsdam
    Potsdam, 14482, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01338493
Lead sponsor
Medtronic Spinal and Biologics
Responsible party
Sponsor
First posted
Apr 19, 2011
Start date
Feb 2009
Primary completion
Jul 2013
Completion
Jul 2013
Results posted
Nov 18, 2014
Last update
Jan 28, 2016

Study contacts

Jean-Charles Le Huec, Prof.
principal investigator · CHU Pellegrin Tripode

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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