Degenerative Lumbar Spondylolisthesis
Conditions
Keywords
Degenerative disc disease
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
Interventions
None listed
Sponsors
Olympus Biotech Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion. 2. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent. 3. The patient agrees to complete the necessary clinical and radiographic evaluations.
Exclusion criteria
1\. There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of bone by CT scan | 3+ years post-treatment from the Pivotal study S01-01US |
Secondary
| Measure | Time frame |
|---|---|
| Re-assessments of all clinical parameters from S01-01US | 3+ years post-treatment from the Pivotal study S01-01US |
Countries
Canada, United States
Outcome results
None listed