Skip to main content
OpenTrials
Completed

NCT Number: NCT00215332

CHARITE™ vs. ALIF 5-Year Follow-up

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite Site 13, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHARITE

Device

Lumbar Total Disc Replacement

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

DePuy Spine

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.