Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorProvidence Medical Technology, Inc.
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 questions it aims to answer are:
Is there fusion success at the treated posterior anatomy of each level? Is there an absence of major adverse device related events? Is there an absence of injections (steroid, facet joint, nerve block) or subsequent revision surgery at index levels for symptoms related to back or leg pain?
Researchers will compare a control arm to the treatment arm to see if research results vary from standard minimally invasive supplemental posterior fusion.
Eligible participants will undergo one of the below interventions:
* Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the study device, including pedicle screw and rod fixation. * Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation.
Participants will also be asked to read, understand, and sign the informed consent, attend a Screening/Baseline visit, undergo surgery for their designated intervention, and participate in 5 additional study visits where they will complete surveys for patient reported outcomes and SOC procedures. These visits will occur at the below intervals (based upon surgery day as day 0):
* 6 weeks * 3 months * 6 months * 12 months * 24 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years (Skeletally Mature)
Oswestry Disability Index Score of > 40/100 (Severe Disability).
At least six weeks from symptom onset; or
Have the presence of progressive symptoms or signs of nerve root/ spinal cord compression despite continued non-operative conservative treatment.
Disqualifiers
Any disease or condition that, in the investigator's opinion, would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity).
Any anatomy or condition that makes posterior fusion treatment infeasible (e.g. fused facets).
Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders).
Active systemic infection or infection at the operative site.
Trial design
Design model
Parallel
Treatments tested in this trial
Supplemental Posterior Fusion with Study Device
DeviceTwo-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with supplemental posterior fusion performed using the Study Device, including pedicle screw and rod fixation.
Supplemental Posterior Fusion with Standard Technique
DeviceTwo-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Standard Supplemental Posterior Fusion TechniqueActive comparator 1 intervention
Group B: Supplemental Posterior Fusion with Study DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with fusion success at the treated posterior anatomy of each level.
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.
Time frame
12 months post procedure2
Proportion of participants with freedom from serious adverse event with definite relationship to treatment devices (interbody or posterior devices).
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.
Time frame
12 months post procedure3
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.
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.
Time frame
12 months post procedureSecondary outcomes
1
Proportion of participants with the presence of Interbody bridging bone.
An individual subject is considered a success if there is evidence of bridging trabecular bone across the interbody space identified at both index levels determined using thin-slice CT and assessed by a third-party core imaging laboratory.
Time frame
12 month visit2
Differences in average segmental range of motion of the treated levels
Range of motion for each of the two treated levels will be measured by a third-party core imaging lab.
Time frame
12 month visit3
Differences in average change in disc height of the treated levels
Change in disc height for each of the two treated levels will be measured between the week-6 and 12-month visits by a third-party core imaging lab.
Time frame
12 month visit4
Proportion of participants with freedom from injections (steroid, facet joint, nerve block) or subsequent revision surgery at treated levels for symptoms related to back or leg pain.
A subject will be considered a failure for this endpoint if they require injections or subsequent revision surgery to treat new or recurrent symptoms of back or leg pain after their index surgery.
Time frame
through 24 month visitSponsors and contacts
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Source ClinicalTrials.gov