CORUS-LX System for Lumbar Interbody Fusion
This study is looking at the safety and effectiveness of the CORUS-LX System. This system is used along with lumbar interbody fusion surgery for people with degenerative disc disease and radiculopathy (nerve pain in the leg or buttock) at two levels in their lower back (L4-L5 and L5-S1). The study wants to see if the CORUS-LX System helps achieve successful fusion, prevents serious problems related to the devices, and reduces the need for pain injections or repeat surgeries for back or leg pain. You might be able to join if you are between 18 and 80 years old and need this type of back surgery. The study's current status is unclear.
- Study design
- This is an interventional, randomized controlled trial with a planned enrollment of 250 participants. It compares the CORUS-LX System to standard surgical techniques.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the procedure to assess fusion success and other outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
At a glance
Conditions
Where it's being run
10 sites across 6 statesStudy leadership
- Erik M Summerside, PhD · STUDY_DIRECTOR · Providence Medical Technology
Who to contact
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What this trial measures
- Proportion of participants with fusion success at the treated posterior anatomy of each level.12 months post procedure
An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across the posterior anatomy identified at both index levels determined using thin-slice CT and assessed by a third-party core imaging laboratory.
- Proportion of participants with freedom from serious adverse event with definite relationship to treatment devices (interbody or posterior devices).12 months post procedure
The seriousness and relationship of each adverse event will be adjudicated by a clinical events committee. A subject will be considered a primary endpoint failure if an adverse event is determined by the committee to be serious and to have a relationship to any of the devices used in the procedure including both interbody and posterior devices.
- Proportion of Participants with freedom from injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain.12 months post procedure
A subject will be considered a primary endpoint failure if they require injections or subsequent revision surgery to treat new or recurrent symptoms of back or leg pain after their index surgery.