CARES Lumbar Artificial Disc Registry

Sponsor

DePuy Spine (Industry)

Overall Status

Terminated

CT.gov ID

NCT02139527

Collaborator

(none)

120

Enrollment

Duration (Months)

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

120 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Outcome Measures

Primary Outcome Measures

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.