Finding studies
Finding studies
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Lead
Pioneer Surgical Technology, Inc.
The post market clinical investigation is designed to assess instrumented posterolateral fusion (PLF) using nanOss Bioactive bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1. Preoperatively, the participant will provide his/her medical history and complete self assessment forms. The investigator will perform a clinical evaluation and x-rays will be performed if recent x-rays are not available. Participants will undergo instrumented PLF with an interbody fusion device (with autograft or allograft) using nanOss Bioactive in combination with autograft bone and bone marrow aspirate in one posterolateral gutter and autograft alone in the opposite posterolateral gutter. Following surgery, operative and discharge information will be collected and a clinical evaluation will be performed prior to discharge. Participants will be evaluated 6 and 12 months postoperatively. One investigational site will participate in long-term followup of 24 months. Each participant will complete x-rays and self assessment documents. A CT scan performed at the 12 month postoperative visit will be evaluated by an independent radiologist to assess fusion results. Complication data will be recorded throughout the study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
