Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up

BMC Musculoskeletal Disorders

Jianzhong Xu¹  Wenjie Wu¹  Xiaoliang Tao¹  Xiaofei Wang²  Beiyu Wang²  Yingjun Guo²  Ying Hong²  Yuxiao Deng²  Yang Meng²  Hao Liu²  Chen Ding² 

[1] Department of Orthopaedics, Southwest Hospital, Third Military Medical University, Chongqing, China;Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, China;

关键词: Cervical disc arthroplasty;    Pretic-I;    Discover;    Adjacent segment disease;    Heterotopic ossification;   

DOI  :  10.1186/s12891-021-04813-5

来源: Springer

【 摘 要 】

BackgroundThe newly designed cervical disc prosthesis, Pretic-I, had been finished its limited clinical use for over 5 years. At a short-term follow-up of 2 years, we obtained satisfactory clinical results. The long-term clinical efficacy and safety of Pretic-I will now be analyzed.MethodsPeri-operative parameters included intra-operative blood loss, operation time, off-bed time. Clinical parameters included visual analogue scale (VAS) for arm and neck, neck disability index (NDI), and Japanese Orthopaedic Association (JOA) score. Radiological parameters included C2–7 Cobb angle, Shell angle, and the range of motion (ROM) of C2–7, functional segment unit (FSU), and adjacent FSU. The CDA-related complications included adjacent segment degeneration (ASDeg), adjacent segment disease (ASDis), heterotopic ossification (HO), prosthesis subsidence, prosthesis displacement, and dysphagia.ResultsA total 64 patients from two independent centers received a single-level CDA with Discover (n = 32) and Pretic-I (n = 32), and all of patients finished a 5-year follow-up. There’re no significant differences between two groups in peri-operative parameters. The clinical parameters improved greatly in Pretic-I group (p<0.0001), and there’s no statistical difference from Discover group. Furthermore, Pretic-I could slightly improve the cervical curvature (15.08 ± 11.75 to 18.00 ± 10.61, p = 0.3079) and perfectly maintain the Shell angle (3.03 ± 3.68 to 2.23 ± 4.10, p = 0.1988), cervical ROM (52.48 ± 14.31 to 53.30 ± 11.71, p = 0.8062) and FSU ROM (12.20 ± 4.52 to 10.73 ± 4.45, p = 0.2002). The incidence of high-grade HO (Grade III-IV) at the final follow-up was significantly lower in Pretic-I group than in Discover group (12.50% vs. 34.38%, p = 0.0389, Statistical Power = 95.36%). The incidences of other CDA-related complications in Pretic-I group were also well-accepted, comparable to the Discover group, without significant differences.ConclusionCDA with Pretic-I demonstrated a well-accepted and sustained clinical outcome, with a significantly lower incidence of high-grade HO. This newly designed prosthesis is expected to become an alternative choice for cervical disc prosthesis in the future.

【 授权许可】

CC BY