Clinical study shows patient satisfaction with ROTAIO®

Clinical study shows patient satisfaction with ROTAIO®

A US patent has been granted for the artificial cervical disc prosthesis ROTAIO by SIGNUS. 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).

A recently published prospective observational study with 24-month follow-up [1] 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 anterior cervical discectomy and fusion (ACDF), which is often associated with a high rate of arthrodesis and a loss of segmental mobility, and consequent pseudo-arthritis or adjacent segment degeneration (ASD) [2,3]. Cervical disc arthroplasty (CDA) seems an alternative for ACDF as it minimises the risk of ASD.

In a non-interventional study, 45 patients (aged 18 to 65) were treated with a ROTAIO prosthesis. Based on standardised 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.

For all parameters studied, 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: 66.7 per cent of patients took pain relievers ‘often’ or ‘always’ prior to implantation. At the last follow-up a reduction was observed. 45.8 per cent of the patients rated their use of pain relievers as ‘never‘, 33.3 per cent as ‘seldom‘. All patients (100 per cent) 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 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.

 

References

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

Fraser JF, Härtl R. Anterior approaches to fusion of the cervical spine: a metaanalysis of fusion rates. J Neurosurg Spine. 2007;6:298-303

Upadhyaya CD, et al. Analysis of the three US Food and Drug Administration investigational device exemption cer- vical arthroplasty trials. J Neurosurg Spine. 2012;16:216-228

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