Degenerative Disc Disease Clinical Trial
— SPOOfficial title:
BIOMET/EBI (Electro-Biology, Inc) Spine Patient Outcomes Registry
| NCT number | NCT00726284 |
| Other study ID # | CS-006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2004 |
| Est. completion date | December 6, 2007 |
| Verified date | February 2020 |
| Source | Zimmer Biomet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
| Status | Completed |
| Enrollment | 651 |
| Est. completion date | December 6, 2007 |
| Est. primary completion date | December 6, 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: N/A Exclusion Criteria: N/A |
| Country | Name | City | State |
|---|---|---|---|
| United States | CNS Healthcare | Akron | Ohio |
| United States | Neurological Surgery Associates | Little Rock | Arkansas |
| United States | Florida Orthopedics Association | Orange City | Florida |
| United States | Pottstown Memorial Medical Center | Pottstown | Pennsylvania |
| United States | Oklahoma Spine and Brain | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Zimmer Biomet |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fusion Status | The primary outcome measure for this trial will be the percentage of successful fusions achieved. | 24 Months | |
| Secondary | Mean VAS (Visual Analog Scale) Score Change from baseline | 24 Month | ||
| Secondary | Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline | 24 Month | ||
| Secondary | neurologic Assessment - maintenance or Improvement | 24 Month | ||
| Secondary | SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline | 24 Month |
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