Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
This study has been completed.
Sponsor:
Olympus Biotech Corporation
Information provided by:
Olympus Biotech Corporation
ClinicalTrials.gov Identifier:
NCT00678353
First received: May 13, 2008
Last updated: June 9, 2011
Last verified: June 2011
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Purpose
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.
| Condition |
|---|
|
Degenerative Lumbar Spondylolisthesis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions |
Further study details as provided by Olympus Biotech Corporation:
Primary Outcome Measures:
- Evidence of bone by CT scan [ Time Frame: 3+ years post-treatment from the Pivotal study S01-01US ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Re-assessments of all clinical parameters from S01-01US [ Time Frame: 3+ years post-treatment from the Pivotal study S01-01US ] [ Designated as safety issue: No ]
| Enrollment: | 202 |
| Study Start Date: | May 2007 |
| Study Completion Date: | August 2007 |
| Groups/Cohorts |
|---|
|
1
Follow-up to S01-01US, conducted to expand information
|
Detailed Description:
Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated in clinical protocol S01-01US
Criteria
Inclusion Criteria:
- The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.
- The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.
- The patient agrees to complete the necessary clinical and radiographic evaluations.
Exclusion Criteria:
1. There are no exclusion criteria for participation in this protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678353
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Hide Study LocationsLocations
| United States, California | |
| Santa Monica, California, United States | |
| Stanford, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Florida | |
| Clearwater, Florida, United States | |
| Ft. Lauderdale, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Kalamazoo, Michigan, United States | |
| Southfield, Michigan, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| New York, New York, United States | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Germantown, Tennessee, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Charlottesville, Virginia, United States | |
| Fairfax, Virginia, United States | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| London, Ontario, Canada | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Olympus Biotech Corporation
More Information
No publications provided
| Responsible Party: | Shinichi Torii, Olympus Biotech |
| ClinicalTrials.gov Identifier: | NCT00678353 History of Changes |
| Other Study ID Numbers: | 06-UPLF-01 |
| Study First Received: | May 13, 2008 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Olympus Biotech Corporation:
|
Degenerative disc disease |
Additional relevant MeSH terms:
|
Spondylolisthesis Spondylolysis Spondylosis |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013