An observational study in Degenerative Lumbar Spondylolisthesis, sponsored by Olympus Biotech Corporation. Completed at 22 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-06-10.
Sponsored by Olympus Biotech Corporation · Observational
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.
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
237 studies on the registry are indexed under Spondylolisthesis; 47 are open to participants now.
This study's enrollment of 202 is above the median of 121 across 80 observational studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Olympus Biotech Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in clinical protocol S01-01US
Exclusion Criteria:
Follow-up to S01-01US, conducted to expand information
Evidence of bone by CT scan
Time frame: 3+ years post-treatment from the Pivotal study S01-01US
Re-assessments of all clinical parameters from S01-01US
Time frame: 3+ years post-treatment from the Pivotal study S01-01US
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Olympus Biotech Corporation