NCT00215332

Brief Summary

To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

10 active sites

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, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

First QC Date

September 14, 2005

Last Update Submit

April 10, 2015

Conditions

Degenerative Disc Disease

Keywords

arthroplastylumbardisc

Outcome Measures

Primary Outcomes (1)

  • Overall Success

    ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.

    5 Years

Secondary Outcomes (1)

  • Secondary Endpoints

    5 Years

Study Arms (3)

Training- CHARITE

Non-Randomized Training (TDR with CHARITE)

Device: CHARITE

CHARITE

Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE

Device: CHARITE

Control

Randomized Subjects treated by ALIF with BAK cage

Interventions

CHARITEDEVICE

Lumbar Total Disc Replacement

CHARITETraining- CHARITE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
  • Still have the original implant they received in their index surgery.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Charite Site 13

Los Angeles, California, 90048, United States

Location

Charite Site 06

Golden, Colorado, 80401, United States

Location

Charite Site 11

Chicago, Illinois, 60640, United States

Location

Charite Site 03

Louisville, Kentucky, 40202, United States

Location

Charite Site 02

Towson, Maryland, 21204, United States

Location

Charite Site 15

Boston, Massachusetts, 02120, United States

Location

Charite Site 14

Lockport, New York, 14094, United States

Location

Charite Site 10

New York, New York, 10003, United States

Location

Charite Site 07

Columbus, Ohio, 43214, United States

Location

Charite Site 01

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Daniel H Stoutenburgh

    DePuy Spine

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Study Completion

July 1, 2007

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

US(10)