Status:
COMPLETED
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Lead Sponsor:
Olympus Biotech Corporation
Conditions:
Degenerative Lumbar Spondylolisthesis
Eligibility:
All Genders
18-85 years
Brief Summary
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.
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, parti...
Eligibility Criteria
Inclusion
- 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
- 1\. There are no exclusion criteria for participation in this protocol.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00678353
Start Date
May 1 2007
End Date
August 1 2007
Last Update
June 10 2011
Active Locations (22)
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1
Santa Monica, California, United States
2
Stanford, California, United States
3
Denver, Colorado, United States
4
Clearwater, Florida, United States