NCT02678130

A Prospective Study of the InterFuse T(tm),

A Prospective Study of the InterFuse T(tm)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vertebral Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.

Detailed description

The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in \[patients undergoing interbody fusion. The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DEVICE	InterFuse T	Transforaminal Lumbar Interbody fusion (TLIF)
DEVICE	Standard of Care TLIF (Stryker AVS Unilif)	Transforaminal Lumbar Interbody Fusion (TLIF)

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-06-01
• Completion: 2019-01-01
• First posted: 2016-02-09
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States