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CARES Lumbar Artificial Disc Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139527
Recruitment Status : Terminated (Low enrollment and follow-up data on enrolled patients.)
First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
DePuy Spine

Study Description
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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.

Condition or disease Intervention/treatment
Lumbar Degenerative Disc Disease Device: Total Disc Replacement

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
Study Start Date : May 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Total Disc Replacement
    Other Names:
    • CHARITE™ Artificial Disc
    • PRODISC®-L Total Disc Replacement

Outcome Measures
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Primary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) Score [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc
Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • None known.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

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Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT02139527    
Other Study ID Numbers: 06-CAD-01
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Keywords provided by DePuy Spine:
arthroplasty
spinal
CHARITE
PRODISC-L
 PRODISC
disc
replacement
lumbar
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases