CHARITE™ vs. ALIF 5-Year Follow-up

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: CHARITE

• Registration Number: NCT00215332
• Lead Sponsor: DePuy Spine

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).

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Completion: 2007-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training- CHARITE	CHARITE	Non-Randomized Training (TDR with CHARITE)
CHARITE	CHARITE	Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE

Primary Outcome Measures

Name	Time	Method
Overall Success	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 Outcome Measures

Name	Time	Method
Secondary Endpoints	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

Trial Locations

Locations (10)

Charite Site 13; 🇺🇸 Los Angeles, California, United States

Charite Site 06; 🇺🇸 Golden, Colorado, United States

Charite Site 02; 🇺🇸 Towson, Maryland, United States

Charite Site 03; 🇺🇸 Louisville, Kentucky, United States

Charite Site 11; 🇺🇸 Chicago, Illinois, United States

Charite Site 10; 🇺🇸 New York, New York, United States

Charite Site 07; 🇺🇸 Columbus, Ohio, United States

Charite Site 14; 🇺🇸 Lockport, New York, United States

Charite Site 15; 🇺🇸 Boston, Massachusetts, United States

Charite Site 01; 🇺🇸 Plano, Texas, United States