NCT02659722

InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)

A Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse® S and InterFuse® T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Vertebral Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..

Detailed description

The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. While there is no concurrent control population, there is ample historical control data to be used for comparison. The study will include up to two hundred (200) patients, up to 10 centers, and provide a prospective evaluation of the InterFuse "T" and/or InterFuse "S" Interbody Fusion System. Primary endpoints will be assessed at twelve months post-surgery. All patients enrolled in the study will be followed for at least 24 months.

Conditions

• Scoliosis
• Back Pain

Interventions

Type	Name	Description
DEVICE	InterFuse	TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-06-01
• Completion: 2019-01-01
• First posted: 2016-01-20
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States