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Not Yet Recruiting NCT07721493

Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

Conditions: Degenerative Disc Disease(DDD)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 225
Sponsor: Providence Medical Technology, Inc.

Location: The Orthopaedic Institute Paducah Kentucky

Summary

The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures. The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit. Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.

Eligibility Criteria

Inclusion Criteria: * At least 18 years of age (Skeletally Mature) * Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following: 1. diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and/or arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes. 2. radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI. * NDI Score of ≥ 15/50 * Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: 1. at least six weeks from radiculopathy or myeloradiculopathy symptom onset; or 2. 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 and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol; * Written informed consent provided by subject. Exclusion Criteria: * Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity) * Active systemic infection or infection at the operative site * History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C * Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement * A prior spine surgery or pseudoarthrosis at the operative levels * Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention * Symptomatic DDD or significant cervical spondylosis at more than two levels * Diagnosis of Spondylolisthesis, grade \>2 * Overt (Segmental) instability measured as a movement on dynamic flex/extend x-rays \> 3.5 mm * Congenital bony and/or spinal cord abnormalities that affect spinal stability * Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia * Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured 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 * Use of epidural steroids within 14 days prior to surgery * A concomitant condition requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as: 1. daily, chronic use of oral steroids of 5 mg/day or greater. 2. 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. * Known allergy to titanium (Ti) * Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression * Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders) * Is pregnant or nursing at time of screening, or with plans to become pregnant throughout the duration of the study. * A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment * Long term use (\>6 months) of opioids (max. daily amount=120 mg morphine equivalents) * 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 * Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible * Use of any other investigational drug or medical device within the last 30 days prior to surgery * 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.

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Source: ClinicalTrials.gov (NCT07721493). StuddyBuddy aggregates publicly available trial information.