LDR Releases 48-Month Trial Results for Spine Device
Hyun Bae, M.D., medical director and director of spine education at Cedars-Sinai Hospital in Los Angeles, Calif., presented data from Austin, Texas-based LDR Holdings Corporation’s Mobi-C trial at the annual meeting of the North American Spine Society, held early October in New Orleans, La. The presentation focused on the 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).
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.
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 percent and 4.0 percent for the one and two-level Mobi-C patients respectively, and 9.9 percent and 15.2 percent for the ACDF patients respectively; and
- 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.
Bae concluded that unlike with 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. He also said that the study results remained consistent from the primary 24-month endpoint through 48-months. Finally, Bae mentioned that the 48-month data might indicate an advantage of cervical disc replacement over ACDF, especially when treating two-level disease.
Austin, Texas-based LDY Holdings makes proprietary spinal surgical technologies.