Maverick Total Disc Replacement in a 'Real World' Patient Population (NCT01338493) | Clinical Trial Compass
CompletedNot Applicable
Maverick Total Disc Replacement in a 'Real World' Patient Population
Canada, France, Germany139 participantsStarted 2009-02
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 patie…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)