CARES Lumbar Artificial Disc Registry

The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02139527

Enrollment

120

Registered

2014-05-15

Start date

2007-05-31

Completion date

2009-08-31

Last updated

2014-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Degenerative Disc Disease

Keywords

arthroplasty, spinal, CHARITE, PRODISC-L, PRODISC, disc, replacement, lumbar

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.

Interventions

DEVICETotal Disc Replacement

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Treated with the lumbar TDR. * Signed IRB approved consent document. Key

Exclusion criteria

* None known.

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026