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Evidence For Fusion In Spine With Orthoss® — EFFISO  

Lumbar Spinal Stenosis Clinical Trial

Official title:
Evidence For Fusion In Spine With Orthoss®

Clinical Trial Summary

This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).

Clinical Trial Description

This clinical investigation is a prospective, non-interventional, uncontrolled clinical trial, organized to generate clinical data on performance and safety of Orthoss® as a bone graft extender mixed with local bone at ratio of 1:1 and pedicle bone marrow aspirate in lumbar spondylodesis involving 1-2 levels. (Orthoss® is CE marked for this indication). If you as a patient have a wear and tear disease of the spine, an operation serves to restore the stability of the spinal column. In order to promote a bony build-up of the lumbar spine segment (fusion), bone replacement material is used in your case as standard. The aim of this observational study is to determine fusion in order to address clinical performance of that bone replacement material. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03853356
Study type Observational
Source Geistlich Pharma AG
Contact Nina Schnüriger
Phone +41 41 492 68 37
Email nina.schnueriger@geistlich.com
Status Recruiting
Phase
Start date January 18, 2019
Completion date January 2026
View Details
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