Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures

Status unconfirmed

Conditions studied: Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)

In brief

The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.

Key facts

Study ID

NCT02171169

Run by

Baxano Surgical, Inc.

People needed

200

Starts

2014-06-01

Expected to finish

2015-05-01

Last updated by the study team

2014-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult aged 18 years or older
• Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
• Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons

You may not qualify if…

• Subject had history of previous back operations at the time of the index procedure
• Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
• Severe scoliosis in the lumbar region
• Subject was or is currently involved in active litigation
• Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery.

Where it is running

• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Michigan Spine Institute — Waterford, Michigan, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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