N/A
Completed N=139
Maverick Total Disc Replacement in a 'Real World' Patient Population
Source: ClinicalTrials.gov NCT01338493 ↗Enrolled (actual)
139
Serious AEs
42.5%
Results posted
Nov 2014
Primary outcomePrimary: Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) — -25.4 units on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI) |
-25.4 | <0.0001 sig |
| 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) |
-4.0 | <0.0001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01338493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.