Trials / Completed
CompletedNCT00678353
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 202 (actual)
- Sponsor
- Olympus Biotech Corporation · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2007-05-01
- Completion
- 2007-08-01
- First posted
- 2008-05-15
- Last updated
- 2011-06-10
Locations
22 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00678353. Inclusion in this directory is not an endorsement.