US-based Medtronic presented seven-year clinical and radiographic outcomes of artificial disc replacement with PRESTIGE cervical disc compared to anterior cervical discectomy and fusion (ACDF) at the Cervical Spine Research Society Annual Meeting held in Los Angeles, California.
Of the 541 patients enrolled, 395 patients (212 PRESTIGE disc and 183 fusion patients) completed seven years of clinical follow-up. Results indicate that significant improvements in pain and functional outcomes achieved by 1.5 months in both groups were sustained at seven years.
Specific findings at seven years included:
– The rate of patient overall success – the primary study endpoint, comprising of important effectiveness and safety measures, was significantly higher (p = 0.010) in the PRESTIGE disc group (72.6%) as compared to fusion (60.0%).
– The rate of maintenance or improvement in neurological status was significantly higher (p = 0.011) compared to fusion (88.2% versus 79.7%).
– Neck pain was significantly lower (p = 0.004) compared to fusion (mean score of 13.1 versus 19.4 on a scale of 0-100).
– The rate of additional surgeries at the index level was significantly lower (p < 0.001, log-rank test from a Kaplan-Meier analysis) compared to fusion (4.8% versus 13.7%).
– At seven years, one incident of screw loosening in the investigational group classified as associated with implant/surgical procedure was observed.
PRESTIGE cervical sisc is a stainless steel device and articulates via a ball and trough mechanism. It was the first artificial cervical disc FDA-approved for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy). Risks of the PRESTIGE cervical disc include, but are not limited to: development of new radiculopathy, myelopathy or pain.
Medtronic’s Spinal business Global Cervical Spine Therapies vice president Patrick Wilson noted the company is pleased to be the first company to offer seven-year level-one clinical evidence on cervical disc replacement.
"Both physicians and patients will benefit from access to this information when making decisions about the PRESTIGE® Disc," Wilson added.