Lumbar Degenerative Disc Disease Clinical Trial
Official title:
The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
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] |
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
DePuy Spine |
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 |
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