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

Degenerative Disc Disease Clinical Trial

— Maverick  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338493
• Other study ID #: Maverick Global Registry
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: January 26, 2016
• Start date: February 2009
• Est. completion date: July 2013

Study information

• Verified date: January 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Quebec
France	CHU Pellegrin Tripode	Bordeaux
France	CH Antoine Béclère - Service de Chirurgie Orthopédique	Clamart
France	Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon	Clichy
France	Clinique de Neurochirurgie Hôpital Roger Salengro	Lille Cedex
France	CH La Timone	Marseille
France	CH de Meulan - Service de Chirurgie Orthopédique	Meulan
France	Service de Neurochirurgie Hôpital Nice	Nice
France	CH Lariboisière, Service de Neurochirurgie	Paris
France	Clinique du Cours Dillon	Toulouse
Germany	Charité Berlin - Klinik für Orthopädie	Berlin
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Praxis für Orthopädie und Neurochirurgie Potsdam	Potsdam

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No