76. Reduction in opioid medication use after arthroplasty with Prestige LP cervical disc as compared to ACDF in patients with two-level surgery: a randomized study with 10-year follow-up

BACKGROUND CONTEXT Evaluation of 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) using the Prestige LP™ disc to treat degenerative cervical spine disease at two adjacent levels has been completed and published. One of the contributing factors to the current opioid crisis in the U. is increased opioid prescription for back and neck pain. Better surgical outcomes may lead to less use of pain medications for CDA patients. PURPOSE To compare narcotic medication use between cervical disc arthroplasty (CDA) with the Prestige LP disc and anterior cervical discectomy and fusion (ACDF) at two levels. STUDY DESIGN/SETTING Multicenter, prospective, randomized, controlled, FDA-approved clinical trial. PATIENT SAMPLE A total of 397 subjects having 2-level intractable cervical radiculopathy and/or myelopathy were randomized to receive CDA (n=209) or ACDF (n=188) in an FDA-regulated clinical trial. The 10-year follow-up rate was 86% after excluding subjects at sites not participating in the PAS study, deaths, and withdrawals. OUTCOME MEASURES Subject ratings of use of pain medications for neck/arm pain, respectively for each of four types of medications: (1) weak narcotic, (2) strong narcotic, (3) non-narcotic, and (4) muscle relaxant, in a frequency scale: “not at all,” “once a week/as needed,” “once a couple of days,” “once or twice a day,”, and “three times or more a day.” Weak and strong narcotic medication use was combined for a total narcotic use score and further categorized into “ METHODS Data were obtained during the FDA-approved clinical trial, and although not considered as safety or efficacy outcomes for the trial, data were later analyzed for the current study. At preoperative and all postoperative visits up to 10 years, subjects were asked how often during the last week they used pain medications. Pain medication use was statistically compared between CDA and control group ACDF patients at 6 weeks, 3 and 6 months, and 1, 2, 3, 5, 7, and 10 years postoperatively. RESULTS Prevalence of preoperative use of narcotic medications once or more a day was not significantly different between the treatment groups (47.8% for CDA and 44.4% for ACDF). Prevalence decreased substantially for both groups after surgery, but was significantly lower for CDA than ACDF (p CONCLUSIONS The percentage of subjects who used opioid medications once or more a day after receiving the Prestige LP CDA was statistically lower than that in the ACDF group overall and at most postoperative time points. The greater clinical outcome improvements shown in the clinical trial may have led to less use of narcotic medications for CDA patients. For future studies, the use of narcotics after surgery might be considered as a treatment outcome in addition to patient-reported functional and pain outcomes. FDA DEVICE/DRUG STATUS Prestige LP™ Disc, approved for 2-level cervical disc arthroplasty in 2016 (Approved for this indication).