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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Procedure: lumbar spinal arthroplasty + Maverick™

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient eligibility is determined according to labeling

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lumbar spinal arthroplasty + Maverick™; Patients requiring total disc replacement	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: Maverick Global Registry