Radiculopathy LumbarILIFNCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
A study testing Supplemental Posterior Fusion with Study Device and Supplemental Posterior Fusion with Standard Technique in people with Radiculopathy Lumbar and Degenerative Lumbar Disc Disease, run by Providence Medical Technology, Inc. at 12 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiculopathy Lumbar, Degenerative Lumbar Disc Disease
- What is being tested?
- Supplemental Posterior Fusion with Study Device and Supplemental Posterior Fusion with Standard Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Dec 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years (Skeletally Mature)
- Indicated for lumbar interbody fusion for treatment of degenerative lumbosacral disease at two contiguous disc levels between L4-S1 as determined by the following:
- Diagnosis of radiculopathy of the lumbar spine, with pain, including at least one of the following: i) Leg and/or buttock pain, weakness, numbness, or paresthesia ii) Low back pain iii) Neurogenic claudication b) Radiographically determined pathology (CT, MRI, X-rays) at the levels to be treated correlating to primary symptoms including at least one of the following: i) Decreased disc height in comparison to a normal adjacent disc. ii) Degenerative instability ≤ grade 1 spondylolisthesis (<25% slip). iii) Recurrent disc herniation. iv) Central and/or foraminal stenosis.
- Oswestry Disability Index Score of > 40/100 (Severe Disability).
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- At least six weeks from symptom onset; or
Show all 11Show fewer
- Have the presence of progressive symptoms or signs of nerve root/ spinal cord compression despite continued non-operative conservative treatment.
- Reported to be medically cleared for surgery.
- Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms
- Willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
- Written informed consent provided by subject.
Who cannot join
- 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.
- Anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- Previous trauma to any of the L3 to S1 levels resulting in significant bony or disco-ligamentous lumbar spine injury that may prevent device placements.
Show all 33Show fewer
- Prior instrumented surgery or pseudoarthrosis at the operative or adjacent levels.
- Indicated for or history of laminectomy at any of the index or adjacent levels
- Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgery
- Leg, buttocks, or back pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.
- Symptomatic disc degeneration requiring surgical intervention at more or less than two levels.
- Diagnosis of spondylolisthesis, grade >1.
- Diagnosis of lytic spondylolisthesis
- Diagnosis of iatrogenic, traumatic, or dysplastic spondylolisthesis
- Congenital bony and/or spinal cord abnormalities affecting spinal stability.
- Diagnosis of Paget's disease, osteomalacia or any other metabolic bone disease other than osteopenia.
- Diagnosis of osteoporosis, defined as a previous DEXA bone density T-score of ≤-2.5.
- Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years.
- Has an uncontrolled seizure disorder.
- Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
- Use of epidural steroids within 14 days prior to surgery.
- A concomitant condition requiring daily, high-dose oral steroids.
- High dose steroid use is defined as:
- Daily, chronic use of oral steroids of 5 mg/day or greater (steroid inhalers are not exclusionary).
- Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40 mg within one month of the study procedure.
- Long-term use (>6 months) of opioids >120 mg morphine equivalents.
- Known allergy to titanium (Ti)
- A current or recent history (≤1 year prior to screening) of substance abuse that required medical treatment.
- Is pregnant, nursing, or interested in becoming pregnant within the next 3 years from the time of screening.
- Participation as a subject in any other clinical studies involving medical devices or drugs in the last 30 days prior to surgery
- A pending personal litigation relating to spinal injury (worker's compensation is not exclusionary).
- Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.
- A mental illness or belongs to a vulnerable population, as determined by the investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 11 recruiting
- Not yet recruiting
Olympia Neurological Institute
Austin, Texas, 78745
Nguyen Nguyen Clinical Research Coordinator, 512-409-9903, texas.ini.research@inifoundation.org
Jordan Amadio, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Allison Reynolds Clinical Research Coordinator, 614-814-6768, Allison.Reynolds@osumc.edu
Allie Garvin Clinical Research Coordinator, 614-688-8304, Allison.garvin@osumc.edu
- Terminated
Spine Physician Institute
Dallas, Texas, 75234
- Recruiting
American Neurospine Institute
Frisco, Texas, 75033
Gladcy Mathew, Clinical Research Coordinator, 469 989 3768, Gladcy.Mathew@hcahealthcare.com
Ripul Panchal, MD
- Recruiting
Orthopaedic Spine Institute
Hinsdale, Illinois, 60521
Shanti Badra, Clinical Research Coordinator, 630-381-1381, ma@osiclinic.com
Vivek Mohan, MD
- Recruiting
California Spine
Los Angeles, California, 90033
Inaara Bhola, Clinical Research Coordinator, 323-573-5116, inaara@california-spine.com
Mohsin Fidai, MD
- Recruiting
Golden State Orthopedics & Spine
Los Gatos, California, 95032
Alaa Khabaza Clinical Research Coordinator, (800) 943-8099, alaa.khabaza@goldenstateortho.com
Will Zirl Clinical Research Coordinator, (800) 943-8099, wzirl@goldenstateortho.com
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Catherine Gang Clinical Research Coordinator, 212-224-7980, gangh@hss.edu
Madison Myers Clinical Research Coordinator, myersm@hss.edu
- Recruiting
Huntsman Spine
Salt Lake City, Utah, 84124
Alex Reedy, Clinical Research Coordinator, 801-346-7788 ext. 1013, areedy@saon.net
Kade Huntsman, MD
- Recruiting
Barrow Brain & Spine
Scottsdale, Arizona, 85251
Helen Riahi, Clinical Research Coordinator, 480-583-0295, hriahi@honorhealth.com
Bryan Lee, MD
- Recruiting
HonorHealth Neurology
Scottsdale, Arizona, 85251
Mattie Wheeler, Clinical Research Coordinator, 480-534-4525, mawheeler@honorhealth.com
Abhineet Chowdhary, MD
- Recruiting
Atlantic Brain and Spine
Wilmington, North Carolina, 28401
Bridgette Smith Clinical Research Coordinator, (910) 763-3333 ext. 403, b.smith@atlanticbrainandspine.com
Amy Castrovinci Clinical Research Coordinator, (910) 763-3333 ext. 308, a.castrovinci@atlanticbrainandspine.com
About this study
Official title: Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes for the Treatment of Degenerative Lumbosacral Disc Disease.
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?
Read more
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
Read the detailed description
The study device is designed to provide surgeons a tissue-sparing solution for both preparing a fusion bed around the facet space in addition to stabilizing the joint in sync with percutaneous pedicle screw and rod fixation. There have been few rigorous studies looking at the posterior fusion aspect of circumferential lumbar fusion. Through a randomized controlled trial design and multi-modal imaging protocol, we aim to explore whether the opportunity for improved outcomes exists.
This randomized controlled trial was designed to compare outcomes in subjects treated with interbody fusion including supplemental posterior fusion for the treatment of degenerative lumbosacral disease. For the control arm subjects, supplemental posterior fusion will be performed with each surgeon's standard protocol for fusion with pedicle screw and rods. Treatment arm subjects will also receive percutaneous pedicle screw fixation but will also have the posterior anatomy prepared for fusion using the study device. In both arms, all posterior instrumentation will be placed using navigation technology. Study success will be defined as the demonstration of statistical superiority by the treatment arm over the control arm with respect to the primary endpoint, which is the incidence of arthrodesis achieved across the posterior anatomy. Additional data of interest will be collected to explore relationships between observed arthrodesis rates at the posterior anatomy and the rates of arthrodesis across the interbody space, serious device-related adverse events, device failure, subsequent surgical revisions, patient-reported outcomes, and return-to-work measures assessed through 24 months. Eligible subjects will be those with degenerative lumbosacral disease diagnosed at 2 levels between the L4 and S1 segments who are indicated for treatment using an interbody fusion approach supplemented with posterior fusion including pedicle screw and rod fixation. Major exclusionary factors will be history of prior instrumentation at the index or adjacent levels, fused facet or facet hypertrophy that prohibits device implantation, and a diagnosis of osteoporosis.
- Being tested
- Supplemental Posterior Fusion with Study Device, Supplemental Posterior Fusion with Standard Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Posterior Fusion with Study DeviceDevice
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.
Supplemental Posterior Fusion with Standard TechniqueDevice
Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Supplemental Posterior Fusion Technique | Active comparator | Two-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard supplemental posterior fusion including pedicle screw and rod fixation. Receives: Device: Supplemental Posterior Fusion with Standard Technique |
| Supplemental Posterior Fusion with Study Device | Experimental | 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. Receives: Device: Supplemental Posterior Fusion with Study Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post procedure
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.
Measured: 12 months post procedure
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.
Measured: 12 months post procedure
Secondary outcomes (4)
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.
Measured: 12 month visit
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.
Measured: 12 month visit
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.
Measured: 12 month visit
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.
Measured: through 24 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start1 Dec 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Medical Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Jenkins, Study director, Providence Medical Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222787
- Sponsor's protocol ID
- PMT0004
- Acronym
- ILIF
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Specific IPD will be shared on a case-by-case basis after review of proposals by the Sponsor and Investigators.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes for the Treatment of Degenerative Lumbosacral Disc Disease.
- ClinicalTrials.gov ID
- NCT07222787
- Acronym / sponsor ID
- ILIF / PMT0004
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Providence Medical Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study device is designed to provide surgeons a tissue-sparing solution for both preparing a fusion bed around the facet space in addition to stabilizing the joint in sync with percutaneous pedicle screw and rod fixation. There have been few rigorous studies looking at the posterior fusion aspect of circumferential lumbar fusion. Through a randomized controlled trial design and multi-modal imaging protocol, we aim to explore whether the opportunity for improved outcomes exists.
This randomized controlled trial was designed to compare outcomes in subjects treated with interbody fusion including supplemental posterior fusion for the treatment of degenerative lumbosacral disease. For the control arm subjects, supplemental posterior fusion will be performed with each surgeon's standard protocol for fusion with pedicle screw and rods. Treatment arm subjects will also receive percutaneous pedicle screw fixation but will also have the posterior anatomy prepared for fusion using the study device. In both arms, all posterior instrumentation will be placed using navigation technology. Study success will be defined as the demonstration of statistical superiority by the treatment arm over the control arm with respect to the primary endpoint, which is the incidence of arthrodesis achieved across the posterior anatomy. Additional data of interest will be collected to explore relationships between observed arthrodesis rates at the posterior anatomy and the rates of arthrodesis across the interbody space, serious device-related adverse events, device failure, subsequent surgical revisions, patient-reported outcomes, and return-to-work measures assessed through 24 months. Eligible subjects will be those with degenerative lumbosacral disease diagnosed at 2 levels between the L4 and S1 segments who are indicated for treatment using an interbody fusion approach supplemented with posterior fusion including pedicle screw and rod fixation. Major exclusionary factors will be history of prior instrumentation at the index or adjacent levels, fused facet or facet hypertrophy that prohibits device implantation, and a diagnosis of osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Supplemental Posterior Fusion Technique | Active comparator | Device: Supplemental Posterior Fusion with Standard TechniqueTwo-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard supplemental posterior fusion including pedicle screw and rod fixation. |
| Supplemental Posterior Fusion with Study Device | Experimental | Device: Supplemental Posterior Fusion with Study 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-80 years (Skeletally Mature)
- Indicated for lumbar interbody fusion for treatment of degenerative lumbosacral disease at two contiguous disc levels between L4-S1 as determined by the following:
- Oswestry Disability Index Score of > 40/100 (Severe Disability).
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- Reported to be medically cleared for surgery.
Key exclusion criteria (33 listed)
- 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.
- Anticipated treatment for active systemic infection, including HIV or Hepatitis C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental Posterior Fusion with Study 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. | Device | Supplemental Posterior Fusion with Study Device |
| Supplemental Posterior Fusion with Standard TechniqueTwo-level lumbar interbody fusion at L4-L5 \& L5-S1 segments, with standard minimally invasive supplemental posterior fusion including pedicle screw and rod fixation. | Device | Standard Supplemental Posterior Fusion Technique |
Primary outcome
Proportion of participants with fusion success at the treated posterior anatomy of each level.
Time frame: 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).
Time frame: 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.
Time frame: 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.
4 secondary outcomes
Proportion of participants with the presence of Interbody bridging bone.
Time frame: 12 month visit
Differences in average segmental range of motion of the treated levels
Time frame: 12 month visit
Differences in average change in disc height of the treated levels
Time frame: 12 month visit
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.
Time frame: through 24 month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Services US Department of Health and Human. Guidance document for the preparation of IDEs for spinal systems. Washington (DC): Food and Drug Administration Center for Devices and Radiological Health. 2000.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Specific IPD will be shared on a case-by-case basis after review of proposals by the Sponsor and Investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matt Jenkins study director
Providence Medical Technology
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental Posterior Fusion with Study Device and Supplemental Posterior Fusion with Standard Technique in people with Radiculopathy Lumbar and Degenerative Lumbar Disc Disease, run by Providence Medical Technology, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Jenkins (805-450-4965, ILIF@providencemt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with fusion success at the treated posterior anatomy of each level. (time frame: 12 months post procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.