CHARITE™ vs. ALIF 5-Year Follow-up

DePuy Synthes

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: CHARITE

Study type: Observational

Funder types: Industry

Identifiers

NCT00215332

P040006

Details and patient eligibility

About

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).

Full 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.

Enrollment: 367 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

367 participants in 3 patient groups

Training- CHARITE

Description:

Non-Randomized Training (TDR with CHARITE)

Treatment:

Device: CHARITE

CHARITE

Description:

Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE

Treatment:

Device: CHARITE

Control

Description:

Randomized Subjects treated by ALIF with BAK cage