Clinical trial NCT01338493: Maverick Total Disc Replacement in a 'Real World' Patient Population
Official title: Maverick Total Disc Replacement in a 'Real World' Patient Population - A Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient eligibility is determined according to labeling

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.


Eligibility 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.

Primary outcomes:
measure: Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)
timeFrame: 6 months
Secondary outcomes:
measure: Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Montreal General Hospital
city: Bordeaux
country: France
facility: CHU Pellegrin Tripode
city: Clamart
country: France
facility: CH Antoine Béclère - Service de Chirurgie Orthopédique
city: Clichy
country: France
facility: Service de Chirurgie Orthopédique, AP-HP, Hôpital Beaujon
city: Lille Cedex
country: France
facility: Clinique de Neurochirurgie Hôpital Roger Salengro
city: Marseille
country: France
facility: CH La Timone
city: Meulan
country: France
facility: CH de Meulan - Service de Chirurgie Orthopédique
city: Nice
country: France
facility: Service de Neurochirurgie Hôpital Nice
city: Paris
country: France
facility: CH Lariboisière, Service de Neurochirurgie
city: Toulouse
country: France
facility: Clinique du Cours Dillon
city: Berlin
country: Germany
facility: Charité Berlin - Klinik für Orthopädie
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Potsdam
country: Germany
facility: Praxis für Orthopädie und Neurochirurgie Potsdam
Study officials:
affiliation: CHU Pellegrin Tripode
name: Jean-Charles Le Huec, Prof.
role: PRINCIPAL_INVESTIGATOR
References: