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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215306
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
DePuy Spine

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: CHARITÉ Artificial Disc Device: Anterior Interbody Fusion with BAK Cage Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.
Study Start Date : March 2000
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lumbar TDR
CHARITÉ Artificial Disc
Device: CHARITÉ Artificial Disc
Active Comparator: ALIF
Anterior Interbody Fusion with BAK Cage
Device: Anterior Interbody Fusion with BAK Cage

Primary Outcome Measures :
  1. Pain and Function (Oswestry Disability Index)
  2. Neurologic Function
  3. Major Adverse Events
  4. Subsequent Surgical Interventions

Secondary Outcome Measures :
  1. Adverse Events
  2. Back and Leg Pain (VAS)
  3. SF-36; Health Related Quality of Life
  4. Disc Space Height
  5. Fusion (control only)
  6. Angular Range of Motion
  7. Duration of Hospitalization
  8. Work Status
  9. Patient Satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications of Results:
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Responsible Party: DePuy Spine Identifier: NCT00215306    
Other Study ID Numbers: 990303
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by DePuy Spine:
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases