Degenerative Disc Disease
Conditions
Brief summary
The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
Detailed description
The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.
Interventions
DEVICECharite Artificial Disc
Insertion of the Charite
DEVICELumbar Artificial Disc
Insertion of the Kineflex Lumbar ArtificialDisc
Sponsors
SpinalMotion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Summary: * Be between 18 and 60 years of age * Have evidence of degenerative disc disease (DDD) * History of back and/or radicular pain which is severe, ongoing and recurrent * Minimum 6 month period of prior conservative care * Moderate Oswestry Disability Index score * Moderate pain score * Be likely to return for all follow-up visits * Be willing and able to provide Informed Consent for study participation.
Exclusion criteria
Summary: * Any back or leg pain of unknown origin * Foot drop * Previous trauma to the study treatment level with compression or bursting * Previous retroperitoneal surgery * Other spinal surgery at affected level except IDET, laminotomy * Previous thoracic or lumbar fusion * Documented abnormal abdominal vessel or muscular/fascial pathology or morphology * Degenerative spondylolisthesis * Ischemic (spondylolytic) spondylolisthesis * Spondylitis * Documented significant spinal, foraminal or lateral stenosis * Severely reduced disc space height * Documented presence of free nuclear fragment * Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray * Scoliosis of the lumbar spine * Metabolic bone disease * Active systemic infection * Hepatitis * Active malignancy or history of metastatic malignancy * Any terminal or autoimmune disease * Any other disease, condition or surgery which might impair healing * Recent history of chemical or alcohol dependence * Current or extended use of any drug known to interfere with bone or soft tissue healing * Known metal allergy * Morbid obesity * Transitional vertebrae at level to be treated that has not clearly fused * Currently a prisoner * Currently involved in spinal litigation * Currently experiencing an episode of major mental illness * Pregnancy at time of enrollment, since this would contraindicate abdominal surgery * Participation in another drug, diologic or medical trial within 30 days of study surgery * Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Pain improvement | 24 months |
| Significant disc height increase | 24 months |
| No displacement or migration of the device | 24 months |
| Maintenance or improvement in neurologic status | 24 months |
| Time to recovery | 24 months |
| Preservation of at least 4 degrees of motion in flexion/extension | 24 months |
| Time to return to work | 24 months |
Countries
United States
Outcome results
None listed