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

• ClinicalTrials.gov Identifier: NCT01338493
• Recruitment Status: Completed
• First Posted: April 19, 2011
• Results First Posted: November 18, 2014
• Last Update Posted: January 28, 2016
• Sponsor: Medtronic Spinal and Biologics
• Information provided by (Responsible Party): Medtronic Spinal and Biologics

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Degenerative Disc Disease	Procedure: lumbar spinal arthroplasty + Maverick™

Study Design

• Study Type: Observational
• Actual Enrollment: 139 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patient eligibility is determined according to labeling

Criteria

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.

Contacts and Locations

Locations

Canada

Montreal General Hospital

Quebec, Canada, H3G1A4

France

CHU Pellegrin Tripode

Bordeaux, France, 33076

CH Antoine Béclère - Service de Chirurgie Orthopédique

Clamart, France, 92141

Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon

Clichy, France, 92110

Clinique de Neurochirurgie Hôpital Roger Salengro

Lille Cedex, France, 59037

CH La Timone

Marseille, France, 13385

CH de Meulan - Service de Chirurgie Orthopédique

Meulan, France, 78250

Service de Neurochirurgie Hôpital Nice

Nice, France, 06300

CH Lariboisière, Service de Neurochirurgie

Paris, France, 75010

Clinique du Cours Dillon

Toulouse, France, 31300

Germany

Charité Berlin - Klinik für Orthopädie

Berlin, Germany, 10117

Universitätsklinikum Magdeburg

Magdeburg, Germany, 39120

Praxis für Orthopädie und Neurochirurgie Potsdam

Potsdam, Germany, 14482

Sponsors and Collaborators

Medtronic Spinal and Biologics

Investigators

• Principal Investigator: Jean-Charles Le Huec, Prof.; CHU Pellegrin Tripode

More Information

• Responsible Party: Medtronic Spinal and Biologics
• ClinicalTrials.gov Identifier: NCT01338493
• Other Study ID Numbers: Maverick Global Registry
• First Posted: April 19, 2011
• Results First Posted: November 18, 2014
• Last Update Posted: January 28, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases