CARES Lumbar Artificial Disc Registry

May 13, 2014 updated by: DePuy Spine

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • None known.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3, 6, 12, 24, 36, 48, and 60 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-CAD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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