CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease

Study Overview
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Brief Summary
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The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5 or L5/S1).

Detailed Description
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Treatments for disc degeneration have historically included conservative modalities, such as rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there are two main surgical techniques for treatment of disc degeneration: (1) nucleotomy or diskectomy, i.e., excision of part or all of the degenerated disc, which is typically performed for treatment of radicular syndrome in the case of disc herniation; and (2) spinal fusion, i.e., grafting bone between the vertebrae adjacent to the degenerated disc to eliminate articulation at the damaged segment, which is typically performed for treatment of degeneration together with instability and reduction of the intervertebral space. Rigid internal fixation may also be used to promote fusion. The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of degenerative disc disease as an alternative to spinal fusion to preserve function in the lumbar vertebral region. Each institution participating in the study was to treat the first 5 consecutive study participants with the CHARITE to as it involves a modification to the technique used for anterior fusion. Data will be collected on these training cases but will not be included in the comparison with the control (fusion) treatment. Comparison: Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared to outcomes for patients treated with anterior lumbar interbody fusion.

Official Title
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Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: CHARITÉ Artificial Disc
* Device: Anterior Interbody Fusion with BAK Cage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 60 years of age inclusive symptomatic degenerative disc disease confirmed by provocative discogram single level disease L4/L5 or L5/S1 leg or back pain without nerve root compression VAS pain score >= 40 Oswestry Disability Index score >= 30 six months prior conservative treatment appropriate for anterior surgical approach Exclusion Criteria: previous lumbar or thoracic fusion other spinal surgery at target level symptomatic multiple level degeneration non-contained or extruded nucleus pulposus compression or burst at L4, L5, or S1 due to trauma mid-sagittal stenosis < 8mm osteoporosis, osteopenia, or other metabolic bone disease of the spine spondylolisthesis > 3mm, scoliosis > 11 degrees facet joint arthrosis isthmic spondylolisthesis positive straight leg raise for radiculopathy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar TDR<br>CHARITÉ Artificial Disc | Device: CHARITÉ Artificial Disc<br> <br> |
| Active Comparator: ALIF<br>Anterior Interbody Fusion with BAK Cage | Device: Anterior Interbody Fusion with BAK Cage<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Function (Oswestry Disability Index) |  |  | 
| Neurologic Function |  |  | 
| Major Adverse Events |  |  | 
| Subsequent Surgical Interventions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| Back and Leg Pain (VAS) |  |  | 
| SF-36; Health Related Quality of Life |  |  | 
| Disc Space Height |  |  | 
| Fusion (control only) |  |  | 
| Angular Range of Motion |  |  | 
| Duration of Hospitalization |  |  | 
| Work Status |  |  | 
| Patient Satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroplasty, lumbar, spine