NCT02704689

AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Stryker Spine · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.

Detailed description

Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis, Grade 1
• Retrolisthesis

Interventions

Type	Name	Description
DEVICE	AccuLIF expandable TLIF cage	AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.

Timeline

• Start date: 2016-06-08
• Primary completion: 2017-01-19
• Completion: 2017-01-19
• First posted: 2016-03-10
• Last updated: 2018-04-24
• Results posted: 2018-04-24

Locations

1 site across 1 country: United States