Clinical studies on LDR’s Mobi-C cervical disc presented at NASS

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At the annual meeting of the North American Spine Society (NASS; 23–27 October, Dallas, USA), according to a LDR press release, the first completed investigation device exemption (IDE) trial of cervical arthroplasty for treatment of degenerative disc disease at two levels demonstrated the advantages of two-level arthroplasty with Mobi-C (LDR) over two-level anterior cervical discectomy and fusion (ACDF) in terms of improvements in pain and function and a reduction in revision rates.

Christopher Lavigne, president and CEO of LDR, said: “We are enthusiastic about the volume of clinical data that supports the use of Mobi-C in total disc replacement (TDR) as compared to anterior cervical fusion for treating one- and two-level cervical degenerative disc disease (DDD). We look forward to offering a new and potentially superior treatment alternative to indicated patients in the United States.” The data presented at NASS included:

  • Cervical disc replacement: Evolution of adjacent segments after three Years—JP Steib, et al: This study analysed 224 adjacent segments that have been evaluated after a single or multilevel cervical disc replacement in 142 patients in France. The results at three years support the hypothesis that cervical arthroplasty preserves or at least does not accelerate the degenerative process at adjacent levels. The study will continue for a total of 10 years in order to learn more about long-term adjacent disc status above and below single or multilevel cervical disc replacement.

  • Comparison of outcomes after treatment of cervical degenerative disc disease at one or two levels with total disc replacement—Reginald Davis et al:The study results, which compared the efficacy of treatment of cervical degenerative disc disease (DDD) with the Mobi-C at one or two contiguous levels of the cervical spine, suggested that unlike ACDF, there is no evidence of a reduction in efficacy or an increase in complications as the number of levels treated with Mobi-C increases from one level to two levels. This may represent an advantage of total disc replacement with Mobi-C over ACDF, especially for treating two-level cervical pathology.

  • Outcomes of cervical total disc replacement with up to five years follow-up: A prospective study of 384 Patients—JP Steib et al: This is a report on 384 patients as part of an ongoing prospective, multicenter study in France evaluating the clinical and radiological outcomes of cervical disc replacement (CDR) with the Mobi-C Cervical Disc. The results suggest that cervical disc replacement (CDR) with Mobi-C provides favourable clinical outcomes and maintains motion at the implanted levels. The reoperation rate for the initial indication and the operation rate at the adjacent disc levels are reportedly low at five years suggesting good long-term durability of the procedure.

  • Number of levels involved at index surgery significantly affects the outcomes after anterior cervical discectomy and fusion: Analysis of data from a multicenter prospective randomised controlled trial—Pierce Nunley et al: The study, which assessed and compared the outcomes for the fusion procedure at 24 months, found that rates of complications and subsequent surgical interventions are higher after two-level ACDF in the 24 months following index surgery. 


A LDR press release stated that Mobi-C has been designed for cervical intervertebral disc replacement to maintain segmental motion and restore disc height. it adds that the cobalt chrome alloy and polyethylene device is designed to accommodate the segmental instantaneous centre of rotation via a mobile-bearing core, reducing bone stresses and eliminating the need for invasive vertebral anchorage. Also, it says that the Mobi-C has been used in more than 15,000 implantations outside of the United States since 2004 in more than 20 countries and is currently under Pre-Market Approval (PMA) review by the FDA for both one- and two-level indications

 

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