Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
Recruiting
N/A
Interventional Study
Radiculopathy Lumbar
Degenerative Lumbar Disc Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Providence Medical Technology, Inc. · Industry
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About This Trial
The goal of this clinical trial is to assess the safety and effectiveness of the study device, CORUS-LX, as an adjunct to lumbar interbody fusion, when used in combination with pedicle screw and rod constructs for the treatment of lumbosacral degenerative disease in patients requiring 2 level (L4-S1) lumbar fusion, for the treatment of symptomatic degenerative lumbosacral disc disease. The main qu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18-80 years (Skeletally Mature)
2. Indicated for lumbar interbody fusion for treatment of degenerative lumbosacral disease at two contiguous disc levels between L4-S1 as determined by the following:
a) Diagnosis of radiculopathy of the lumbar spine, with pain, includi…
Contacts