NCT02805985

Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Expanding Orthopedics Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.

Detailed description

As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis
• Retrolisthesis

Interventions

Type	Name	Description
DEVICE	FLXfit™ TLIF Interbody Fusion Device	The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-06-20
• Last updated: 2017-01-25

Locations

1 site across 1 country: United States