NCT00215306

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2000

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

4 years

First QC Date

September 13, 2005

Last Update Submit

May 22, 2014

Conditions

Degenerative Disc Disease

Keywords

arthroplastylumbarspine

Outcome Measures

Primary Outcomes (4)

  • Pain and Function (Oswestry Disability Index)

  • Neurologic Function

  • Major Adverse Events

  • Subsequent Surgical Interventions

Secondary Outcomes (9)

  • Adverse Events

  • Back and Leg Pain (VAS)

  • SF-36; Health Related Quality of Life

  • Disc Space Height

  • Fusion (control only)

  • +4 more secondary outcomes

Study Arms (2)

Lumbar TDR

EXPERIMENTAL

CHARITÉ Artificial Disc

Device: CHARITÉ Artificial Disc

ALIF

ACTIVE COMPARATOR

Anterior Interbody Fusion with BAK Cage

Device: Anterior Interbody Fusion with BAK Cage

Interventions

CHARITÉ Artificial DiscDEVICE
Lumbar TDR
Anterior Interbody Fusion with BAK CageDEVICE
ALIF

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R Jr, Regan JJ, Ohnmeiss DD. A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1565-75; discussion E387-91. doi: 10.1097/01.brs.0000170587.32676.0e.

    PMID: 16025024RESULT

  • McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J. A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1576-83; discussion E388-90. doi: 10.1097/01.brs.0000170561.25636.1c.

    PMID: 16025025RESULT

  • Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004 Sep;1(2):143-54. doi: 10.3171/spi.2004.1.2.0143.

    PMID: 15346999RESULT

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2000

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

May 23, 2014

Record last verified: 2014-05