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  • Two-level Cervical Total Disc Arthroplasty Vs. Anterior Discectomy and Fusion: A Prospective, Randomized, Controlled Multicenter Clinical Trial with 5-year Results

    Final Number:
    683

    Authors:
    Jeffrey McConnell MD; Randall Dryer; Todd H. Lanman MD, FACS; John Kenneth Burkus; Matthew F Gornet MD; Scott Hodges DO

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2015 Annual Meeting

    Introduction: Cervical disc arthroplasty (CDA) is intended to treat symptomatic cervical disc disease (SCDD) while preserving motion. Anterior discectomy and fusion (ACDF) has been the standard treatment, but at the expense of lost motion.Few studies have focused on the safety and efficacy of CDA at 2 levels. At 24 months the PRESTIGE-LP CDA demonstrated superior overall success results vs. 2-level ACDF. This study compares outcomes at 5 years.

    Methods: An FDA IDE trial of the PRESTIGE LP disc was conducted at 30 centers in the US. 397 patients with 2-level SCDD from C3-C7 were randomized and treated with cervical CDA (n=209) or the control treatment, ACDF (n=188). Overall clinical success was defined as improvement in Neck Disability Index (NDI) of 15 points or greater; maintenance or improvement of neurologic status; no implant or surgical related adverse events (AE); and no additional surgical procedures at the index level. NDI, numerical pain scales for neck and arm pain, SF36, radiographic outcomes and patient satisfaction were used to analyze clinical effectiveness.

    Results: At 5 years CDA patients demonstrated statistical superiority over ACDF patients based on Overall Success (79.5% vs 65.9%, posterior probability of superiority (pps) = 99.6%), NDI Success (89.2% vs 77.8%, pps = 99.6%), Neck Pain Success (97.0% vs 91.9%, pps = 97.4%) and SF-36 PCS Success (88.8% vs 80.2%, pps = 98.0%). Subsequent index level surgeries were significantly lower in the CDA group (4.2%) vs ACDF (11.5%). Grade 4 heterotopic ossification occurred in 8.5% of inferior and superior levels in the CDA group.

    Conclusions: The results of this long term study represent Level I clinical evidence in support of cervical disc arthroplasty at two contiguous levels for the treatment of symptomatic cervical disc disease in appropriately selected patients. Motion preservation with cervical disc arthroplasty is a viable alternative to ACDF.

    Patient Care: Superior clinical outcomes can be achieved in patients with two level symptomatic cervical degenerative disc disease using motion preservation with cervical disc arthroplasty versus the traditional treatment of discectomy and fusion.

    Learning Objectives: By the conclusion of this session, participants should be able to: 1. Describe the importance of motion preservation as an alternative to fusion in treating symptomatic cervical disc disease. 2. Identify appropriate patients for two level cervical disc arthroplasty. 3. Discuss Level-1 clinical data comparing two level cervical arthroplasty versus fusion for symptomatic cervical disc disease.

    References: Burkus JK, Traynelis VC, Haid RW Jr, Mummaneni PV. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. 2014 Oct;21(4):516-28.

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