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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00215306
First received: September 13, 2005
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Degenerative Disc Disease
Device: CHARITÉ Artificial Disc
Device: Anterior Interbody Fusion with BAK Cage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the SB Charite III Intervertebral Disc Spacer.

Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Pain and Function (Oswestry Disability Index)
  • Neurologic Function
  • Major Adverse Events
  • Subsequent Surgical Interventions

Secondary Outcome Measures:
  • 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

Enrollment: 304
Study Start Date: March 2000
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT00215306     History of Changes
Other Study ID Numbers: 990303
Study First Received: September 13, 2005
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Spine:
arthroplasty
lumbar
spine

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 16, 2014