CARES Lumbar Artificial Disc Registry

Terminated

• Conditions: Lumbar Degenerative Disc Disease

• Registration Number: NCT02139527
• Lead Sponsor: DePuy Spine

Brief Summary

The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.

Detailed Description

The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2014-02-11
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Study First Posted: 2014-05-15
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Treated with the lumbar TDR.
• Signed IRB approved consent document.

Key

Exclusion Criteria

• None known.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI) Score	3, 6, 12, 24, 36, 48, and 60 months post operative	The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.