NCT02317185

Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

CLINICAL EVALUATION OF GENEX® DS IN INSTRUMENTED POSTEROLATERAL FUSION

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Spine Wave · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis
• Stenosis

Interventions

Type	Name	Description
DEVICE	genex bone graft with bone graft
OTHER	autogenous bone graft

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-12-15
• Last updated: 2018-04-19

Locations

2 sites across 1 country: United States