CHARITE™ vs. ALIF 5-Year Follow-up

April 10, 2015 updated by: DePuy Spine

Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.

This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.

Study Type

Observational

Enrollment (Anticipated)

367

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Charite Site 13
    • Colorado
      • Golden, Colorado, United States, 80401
        • Charite Site 06
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Charite Site 11
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Charite Site 03
    • Maryland
      • Towson, Maryland, United States, 21204
        • Charite Site 02
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Charite Site 15
    • New York
      • Lockport, New York, United States, 14094
        • Charite Site 14
      • New York, New York, United States, 10003
        • Charite Site 10
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Charite Site 07
    • Texas
      • Plano, Texas, United States, 75093
        • Charite Site 01

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training- CHARITE
Non-Randomized Training (TDR with CHARITE)
Device: CHARITE
Lumbar Total Disc Replacement
CHARITE
Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE
Device: CHARITE
Lumbar Total Disc Replacement
Control
Randomized Subjects treated by ALIF with BAK cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success
Time Frame: 5 Years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoints
Time Frame: 5 Years
Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Spine

Investigators

  • Study Director: Daniel H Stoutenburgh, DePuy Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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