Prospective Multicenter Trial of Cervical Arthroplasty With the ROTAIO® Cervical Disc Prosthesis

Fleck, Steffen; Lang, Anna Maria; Lehmberg, Jens; Landscheidt, Julia Fee; Gerlach, Rüdiger; Rathert, Julian; Schär, Ralph T.; Ulrich, Christian; Müller, Jan-Uwe; Hartmann, Sebastian; Thomé, Claudius (2021). Prospective Multicenter Trial of Cervical Arthroplasty With the ROTAIO® Cervical Disc Prosthesis Research Square 10.21203/rs.3.rs-450035/v1

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Objective

Anterior Cervical Discectomy and Arthroplasty (ACDA) is an established treatment for degenerative cervical disc disease and seems to be an alternative to fusion in minimizing the risk of Adjacent Segment Disease (ASD). The ROTAIO® cervical disc prosthesis is a novel unconstrained implant with a variable center of rotation aiming at physiological motion. The objective of this multicenter prospective trial was to evaluate clinical outcome and complications within 2 years.

Material and Methods

120 patients (72 females and 48 males with a median age of 43.0 years; range: 23 to 60 years) underwent ACDA (ROTAIO®, SIGNUS Medical, Alzenau, Germany) and were prospectively followed for 24 months. Preoperative complaints were mainly associated with radiculopathy (n=104) or myelopathy (n=16). There were 108 monosegmental and 12 bisegmental procedures including 6 hybrid constructs.

Clinical outcome was evaluated at 3, 12 and 24 months by the Visual Analogue Scale (VAS) for head, neck and arm pain, the Neck Disability Index (NDI), the Work Limitation Questionnaire (WL-26), the Patient`s Satisfaction Index (PSI) and a Quality of Life Questionnaire (SF-36). The Nurick Score, the Modified Japanese Orthopaedic Association Score (mJOA) plus a Composite Success Rate have been additionally applied. Finally, complications, the patient`s overall satisfaction and the amount of analgesics were assessed.

Results

Highly significant clinical improvements were observed according to NDI and VAS (p<0.0001 (arm); p<0.001 (neck); p=0.002 (head)) at all postoperative time points. Analgetic medication could be reduced after 3 months in 91.3%, after 12 months in 87.1% and after 24 months in 95.2% of patients. Doctor`s visits for cervical spine problems have been reduced in 93.8% after 24 months.

Patient`s overall satisfaction was high after 3, 12 and 24 months with 83.5%, 78.4% and 79.1% of patients, while 4.1%, 6.8% and 7.0% respectively were not satisfied. The composite success rate was 77.5% after 12 months and 76.9% after 24 months. There were no major complications in this series. Slight subsidence of the prosthesis was observed in 2 patients and 3 patients demonstrated fusion after 24 months. 2 patients developed symptomatic foraminal stenosis, so that implant removal and fusion was performed.

Conclusion

The ROTAIO® cervical disc prosthesis is a safe and efficient treatment option for symptomatic degenerative disc disease demonstrating excellent clinical results at 2 years. Outcome proves to be stable over time with very low revision rates.

Interest & Impact

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