CARES Lumbar Artificial Disc Registry

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02139527
• Other study ID #: 06-CAD-01
• Status: Terminated
• Phase: Phase 4
• First received: February 11, 2014
• Last updated: May 13, 2014
• Start date: May 2007
• Est. completion date: August 2009

Study information

• Verified date: May 2014
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Treated with the lumbar TDR.

• Signed IRB approved consent document.

Key Exclusion Criteria:

• None known.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

Device:
• Total Disc Replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3, 6, 12, 24, 36, 48, and 60 months post operative	No