Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00215306
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
DePuy Spine

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date May 23, 2014
Study Start Date  ICMJE March 2000
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Pain and Function (Oswestry Disability Index)
  • Neurologic Function
  • Major Adverse Events
  • Subsequent Surgical Interventions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
Official Title  ICMJE Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE
  • Device: CHARITÉ Artificial Disc
  • Device: Anterior Interbody Fusion with BAK Cage
Study Arms  ICMJE
  • Experimental: Lumbar TDR
    CHARITÉ Artificial Disc
    Intervention: Device: CHARITÉ Artificial Disc
  • Active Comparator: ALIF
    Anterior Interbody Fusion with BAK Cage
    Intervention: Device: Anterior Interbody Fusion with BAK Cage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
304
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
291
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215306
Other Study ID Numbers  ICMJE 990303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DePuy Spine
Study Sponsor  ICMJE DePuy Spine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DePuy Spine
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP