Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

SpinalMotion

Status

Terminated

Conditions

Degenerative Disc Disease

Treatments

Device: Charite Artificial Disc

Device: Lumbar Artificial Disc

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292292

Kineflex

Details and patient eligibility

About

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.

Full 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.

Enrollment

514 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.