CARES Lumbar Artificial Disc Registry

NCT ID: NCT02139527

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-08-31

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.

Conditions

Lumbar Degenerative Disc Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Total Disc Replacement

Intervention Type: DEVICE

Other Intervention Names

CHARITE™ Artificial Disc; PRODISC®-L Total Disc Replacement

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None known.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

06-CAD-01

Identifier Type: -

Identifier Source: org_study_id