NCT03797144

Fenestrated Screw Study

A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.

Conditions

• Degenerative Spinal Disease
• Deformity of Spine

Interventions

Type	Name	Description
DEVICE	CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement	The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.

Timeline

• Start date: 2019-04-18
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2019-01-09
• Last updated: 2021-08-24
• Results posted: 2021-08-24

Locations

6 sites across 5 countries: Belgium, Finland, France, Greece, Italy

Regulatory

• FDA-regulated device study