Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process.
nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
Degenerative Disc Disease
Device: nanOss Bioactive 3D BVF
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Post-Market Assessment Of NanOss Bioactive 3D in the Posterolateral Spine|
- Number of patients with fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.
- Number of participants with improvement in physical disability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of participants with improvement in quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of participants with improvement in pain scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of participants with decreased usage of pain medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Returning to work [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Satisfaction with surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: nanOss Bioactive 3D BVF
Bilateral, instrumented posterolateral fusion surgery where nanOss Bioactive 3D will be hydrated with autologous BMA and placed bilaterally on a bed of local autograft bone spanning the transverse processes of the treated segment. If an interbody fusion is performed, only a PLIF or TLIF with PEEK IBF devices may be performed.
Device: nanOss Bioactive 3D BVF
nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed.
The post market clinical investigation is designed to assess instrumented PLF using nanOss Bioactive 3D bone void filler with autograft bone and bone marrow aspirate in patients with symptomatic spinal stenosis secondary to degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at one or two adjacent levels from L2-S1 characterized by the inclusion and exclusion criteria.
Patients will be evaluated at Preop, discharge, 6 and 12 months. X-rays will be obtained at each visit; Additionally, a CT scan will be performed at the 12 month postoperative visit to assess fusion status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829997
|United States, South Carolina|
|MUSC Neurosurgery & Spine Services|
|Charleston, South Carolina, United States, 29425|
|United States, Wisconsin|
|Milwaukee Spinal Specialists|
|Glendale, Wisconsin, United States, 53212|
|Principal Investigator:||Stephen Robbins, MD||Milwaukee Spinal Specialists|