Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Completed
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Registration Number
- NCT00678353
- Lead Sponsor
- Olympus Biotech Corporation
- 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, 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
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
- There are no exclusion criteria for participation in this protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evidence of bone by CT scan 3+ years post-treatment from the Pivotal study S01-01US
- Secondary Outcome Measures
Name Time Method Re-assessments of all clinical parameters from S01-01US 3+ years post-treatment from the Pivotal study S01-01US