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.
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:
NDI Score of ≥ 15/50
Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
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:
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.
mjenkins@providencemt.com805-450-4965
Participants will be randomly assigned to either the treatment or control arms at 1:1 ratio.
Anterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure
Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF)
sunderwood@providencemt.com520-262-3704
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