Cervical disc arthroplasty seen as safe, effective for two-level cervical degenerative disc disease
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For treatment of cervical degenerative disc disease at two contiguous levels, investigators of this study found arthroplasty with a cervical artificial disc was as effective and safe as anterior cervical discectomy and fusion.
Researchers identified patients from 30 investigational sites and randomized 209 patients to undergo cervical disc arthroplasty with a Prestige LP (Medtronic) artificial disc and 188 patients to undergo anterior cervical discectomy and fusion (ACDF) with a cortical ring allograft and anterior cervical plate. All patients had degenerative disc disease at two adjacent levels, involved with myelopathy and/or radiculopathy. The Neck Disability Index (NDI), Numeric Rating Scales for neck pain and arm pain, SF-36, gait abnormality, disc height, range of motion or fusion, adverse events, additional surgeries and neurological status were used to determine efficacy and safety.
Investigators found an overall success rate at 24 months of 81.4% for patients who underwent arthroplasty and 69.4% for those who underwent ACDF. All individual components of overall success and individual effectiveness endpoints demonstrated noninferiority of treatment for patients who underwent arthroplasty, apart from the SF-36 Mental Component Summary. The NDI success was superior for those who underwent arthroplasty vs. those who underwent ACDF.
According to researchers, 93.3% of patients who underwent arthroplasty and 92% of patients who underwent ACDF experienced adverse events. The rate of patient-reported serious adverse events was significantly higher in patients who underwent ACDF vs. those who underwent arthroplasty. Investigators noted the posterior probability of superiority was 0.996. There were 51% of patients who underwent arthroplasty who achieved radiographic success vs. 82.1% of patients who had ACDF. Heterotopic ossification was seen in 27.8% of the superior levels of patients who underwent arthroplasty and 36.4% of the inferior levels at 24 months postoperatively. – by Monica Jaramillo
Disclosures: Gornet reports he is currently or previously a consultant for Medtronic. Please see the full study for a list of all other authors’ relevant financial disclosures.