Is NCT07222787 recruiting in Frisco, TX?

Yes, NCT07222787 is currently recruiting participants at its Frisco, TX location. This radiculopathy lumbar clinical trial is actively enrolling qualified participants.

How do I join the radiculopathy lumbar clinical trial in Frisco?

To join this clinical trial in Frisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Frisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Radiculopathy Lumbar Clinical Trial in Frisco, TX

About This Radiculopathy Lumbar Study in Frisco

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

Sponsor: Providence Medical Technology, Inc.

Who Can Participate

Inclusion Criteria

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: a) 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

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.

Exclusion Criteria

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Frisco?

Yes, this clinical trial (NCT07222787) has an active research site in Frisco, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Radiculopathy Lumbar Treatment Options in Frisco, TX

If you're searching for radiculopathy lumbar treatment options in Frisco, TX, this clinical trial (NCT07222787) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Frisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced radiculopathy lumbar specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all radiculopathy lumbar clinical trials near you to find additional studies recruiting in your area.

Radiculopathy Lumbar Clinical Trial in Frisco, TX

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