LDR Holding Corporation, a global medical device company focused on designing novel and proprietary spinal surgical technologies, announced that Dr Hyun Bae, pictured, Medical Director and Director of Spine Education at Cedars-Sinai, Los Angeles, presented 48-month safety and efficacy data of both one-level and two-level cervical disc replacement with Mobi-C® compared to traditional anterior cervical discectomy and fusion (ACDF).
Specific findings presented included:
Mean neck disability index (NDI) scores and improvement was similar in both the one-level and two-level Mobi-C® patient cohorts.
Two-level ACDF patients demonstrated statistically significantly less NDI improvement through four years as compared to the one-level ACDF patients.
Reoperation rates at four years were 3.0% and 4.0% for the one and two-level Mobi-C® patients respectively, and 9.9% and 15.2% for the ACDF patients respectively.
Mean range of motion was maintained through four years at the operative levels in both the one-level and two-level Mobi-C® patient cohorts.
In his conclusions, Dr Bae presented that the results of the study suggest that, unlike ACDF, there is no evidence of a reduction in efficacy as the number of levels treated with cervical disc replacement increases from one level to two levels. Further, he stated that the study results remained consistent from the primary 24-month endpoint through 48-months. Finally, Dr Bae mentioned that the 48-month data might indicate an advantage of cervical disc replacement over ACDF, especially when treating two-level disease.
Mobi-C® is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile-bearing feature, Mobi-C® offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.