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OpenTrials
Completed

NCT Number: NCT01338493

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal General Hospital, Québec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

lumbar spinal arthroplasty + Maverick™

Procedure

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.

Primary outcomes

  1. 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'.

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)

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Official study title

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

Acronym: Maverick

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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