NCT03853356

Evidence For Fusion In Spine With Orthoss®

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Geistlich Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Lumbar Spondylolisthesis Involving L4-L5
• Lumbar Spondylolisthesis Involving L5-S1
• Lumbar Spinal Stenosis
• Lumbar Disc Degeneration

Interventions

Type	Name	Description
DEVICE	Orthoss	Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.

Timeline

• Start date: 2019-01-18
• Primary completion: 2025-07-17
• Completion: 2027-01-01
• First posted: 2019-02-25
• Last updated: 2025-09-10

Locations

3 sites across 1 country: Germany