Clinical Trial TitleSafety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an adjunct to posterior cervical fusion, when used in combination with ACDF in the treatment of multi-level cervical degenerative disease.
National Clinical Trial Number:NCT04229017
Clinical Trial Protocol Description:
The FUSE study is a prospective, multi-center, randomized, controlled study to assess the safety and effectiveness of the Posterior Cervical Stabilization System (PCSS) as an adjunct to posterior cervical fusion (PCF), when used in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease (for patients requiring 3 level (C3-C7) cervical fusion, for the treatment of symptomatic cervical degenerative disc disease).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18-80 years of age (Skeletally Mature).
- Have been indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 3 contiguous levels as determined by the following:
- Diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: Neck and/or arm pain, decreased muscle strength, abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.
- Radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, Degenerative spondylosis on MRI, Disc herniation on MRI;
- Have an NDI Score of ≥15/50.
- Are unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- At least six weeks from radiculopathy or myeloradiculopathy symptom onset.
- Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have a Body Mass Index (BMI) greater than 40 kg/m2.
- Have had previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placements.
- Have had a prior spine surgery or pseudoarthrosis at the operative levels.
- Have used epidural steroids within 14 days prior to surgery.
- Have a known allergy to titanium (Ti).
- Are pregnant or nursing at time of screening, or with plans to become pregnant within the next three years.
- Have a current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) that required treatment.
- Have had long term use (>6 months) of opioids (max. daily amount=120 mg morphine equivalents).
- Have a mental illness or belong 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.
- Have any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible.
- Have used any other investigational drug or medical device within the last 30 days prior to surgery.
- Have anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.