CARES Lumbar Artificial Disc Registry

DePuy Spine120 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

120

Conditions

Lumbar Degenerative Disc Disease

Interventions

Total Disc ReplacementDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Treated with the lumbar TDR. * Signed IRB approved consent document. Key Exclusion Criteria: * None known.

Outcomes

Primary Outcomes

Change in Oswestry Disability Index (ODI) Score

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.

Time frame: 3, 6, 12, 24, 36, 48, and 60 months post operative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.