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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Lumbar Artificial Disc
* Device: Charite Artificial Disc


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kineflex Lumbar Artificial Disc<br>Treatment arm | Device: Lumbar Artificial Disc<br>* Insertion of the Kineflex Lumbar ArtificialDisc<br>* Other names: Kineflex Disc;|
| Active Comparator: Charite<br> | Device: Charite Artificial Disc<br>* Insertion of the Charite<br>* Other names: SB Charite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance or improvement in neurologic status |  | 24 months | 
| Pain improvement |  | 24 months | 
| Significant disc height increase |  | 24 months | 
| No displacement or migration of the device |  | 24 months | 
| Time to return to work |  | 24 months | 
| Time to recovery |  | 24 months | 
| Preservation of at least 4 degrees of motion in flexion/extension |  | 24 months |