Presse release ROTAIO®

SIGNUS receives US patent for cervical disc prosthesis

US patent for ROTAIO®

Alzenau, March 1, 2016. A patent was granted for the artificial cervical disc prosthesis ROTAIO® by the United States Patent and Trademark Office. The patent* relates to the anatomical prosthesis design capable of resisting the high forces exerted while the patient is moving (e.g. pivoting, torsional, and combined pivoting and torsional motions). Furthermore, the design allows insertion as a premounted assembly. A recently published prospective observational study with 24 month follow-up1 demonstrates that the ROTAIO® implant is safe and effective in the treatment of symptomatic degenerative cervical disc disease. The study data confirms ROTAIO® as an alternative to ACDF (anterior cervical discectomy and fusion).

Cervical spondylosis and degenerative disc diseases often lead to a compression of one or more nerve roots and/or the spinal cord resulting frequently in cervical radiculopathy and myelopathy. If non-surgical therapies fail, the most common form of treatment is an ACDF.2 However, this intervention is associated with a high rate of arthrodesis and a loss of segmental mobility. The consequences can be pseudo arthritis or adjacent segment degeneration (ASD).3,4

Cervical disc arthroplasty (CDA) - such as the ROTAIO® prosthesis - seems an alternative for ACDF as it minimizes the risk of ASD. The variable rotation center of the implant allows physiologically facet-guided movements and can mimic the natural movement of the healthy disc. These were some of the aspects which were examined in a study published in January.

Clinical study shows high patient satisfaction with ROTAIO®

In a non-interventional study, 45 patients (aged 18 to 65) were treated with a ROTAIO® prosthesis. The surgeries were carried out between January 2011 and December 2012 in two centers (University Clinic for neurosurgery, Innsbruck, Austria and Clinic for Neurosurgery, Munich-Bogenhausen, Germany). Based on standardized questionnaires, various target criteria were collected: neck disability index (NDI), pain intensity in the arm and neck using the visual analogue scale (VAS score) and patient satisfaction index (PSI) as well as the use of pain medication and the overall result. A survey of patients was carried out prior to surgery, directly after the surgery, three to six months after surgery, and one year (28 patients) or two years (17 patients) after surgery. In addition, radiological examinations were carried out.

For all enquired parameters, significant improvement was demonstrated. Thus, NDI improved from 21.6 ± 9.8 prior to implantation to 10.6 ± 8.3 at the second and 10.5 ± 9.3 at the last follow-up examination. The neck VAS score improved significantly from 5.3 ± 2.8 prior to implantation to 2.4 ± 1.8 at the second and 3.3 ± 2.7 at the last follow-up examination. The arm VAS score also improved: from 5.93 ± 3.17 prior to implantation to 1.91 ± 1.81 at the second and 2.88 ± 2.27 at the last follow-up examination.

In addition, the use of pain relievers decreased significantly: 66.7% of patients took pain relievers ‘often’ or ‘always’ prior to implantation. At the last followup a significant reduction was observed. 45.8 % of the patients rated their use of pain relievers with ‘never‘, 33.3% with ‘seldom‘.

All patients (100%) described their condition as ‘good’, ‘significantly better’ or ‘excellent’ after surgery. This remained until the end of the study period for 44 patients. Only one patient (2.2%) reported a significant deterioration in the last follow-up. The PSI showed that all patients except one would definitely or probably undergo the same treatment.

There were no signs of anterior migration, dislocation or sintering in the radiological accompanying investigations. Furthermore, a significant increase of ROM (range of motion) of 6.3° ± 2.9° prior to implantation to 8.4° ± 2.5° was observed at the first follow-up examination and to 8.6° ± 2,8° during the last examination. The sagittal alignment was well restored in all cases.

*US patent number 9,138,326

further information: ROTAIO®

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Sources
1 Obernauer J et al. Cervical arthroplasty with ROTAIO® cervical disc prosthesis: first clinical and radiographic outcome analysis in a multicenter prospective trial. BMC Musculoskelet Disord. 2016 Jan 12;17(1):11.
2 Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. Orthopedics. 2011;34:889.
3 Fraser JF, Härtl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine. 2007;6:298-303.
4 Upadhyaya CD, Wu JC, Trost G, Haid RW, Traynelis VC, Tay B, et al. Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials. J Neurosurg Spine. 2012;16:216-228