CHARITE™ vs. ALIF 5-Year Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Training- CHARITE

Non-Randomized Training (TDR with CHARITE)

CHARITE

Intervention Type DEVICE

Lumbar Total Disc Replacement

CHARITE

Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE

CHARITE

Intervention Type DEVICE

Lumbar Total Disc Replacement

Control

Randomized Subjects treated by ALIF with BAK cage

No interventions assigned to this group

Interventions

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CHARITE

Lumbar Total Disc Replacement

Intervention Type DEVICE

Eligibility Criteria

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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.