CHARITE™ vs. ALIF 5-Year Follow-up

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215332
• Other study ID #: P040006
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: April 10, 2015
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: April 2015
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• CHARITE
Lumbar Total Disc Replacement

Locations

Country	Name	City	State
United States	Charite Site 15	Boston	Massachusetts
United States	Charite Site 11	Chicago	Illinois
United States	Charite Site 07	Columbus	Ohio
United States	Charite Site 06	Golden	Colorado
United States	Charite Site 14	Lockport	New York
United States	Charite Site 13	Los Angeles	California
United States	Charite Site 03	Louisville	Kentucky
United States	Charite Site 10	New York	New York
United States	Charite Site 01	Plano	Texas
United States	Charite Site 02	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary Endpoints	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	No