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

Abstract Background The 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. Method...

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Autores principales:	Yingjun Guo, Hao Liu, Jianzhong Xu, Yuxiao Deng, Xiaoliang Tao, Yang Meng, Xiaofei Wang, Ying Hong, Beiyu Wang, Chen Ding, Wenjie Wu
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Cervical disc arthroplasty Pretic-I Discover Adjacent segment disease Heterotopic ossification Diseases of the musculoskeletal system RC925-935
Acceso en línea:	https://doaj.org/article/8e1070ab72cc40bc8bab37c81f848769
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spelling	oai:doaj.org-article:8e1070ab72cc40bc8bab37c81f8487692021-11-28T12:24:33ZPretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up10.1186/s12891-021-04813-51471-2474https://doaj.org/article/8e1070ab72cc40bc8bab37c81f8487692021-11-01T00:00:00Zhttps://doi.org/10.1186/s12891-021-04813-5https://doaj.org/toc/1471-2474Abstract Background The 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. Methods Peri-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. Results A 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. Conclusion CDA 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.Yingjun GuoHao LiuJianzhong XuYuxiao DengXiaoliang TaoYang MengXiaofei WangYing HongBeiyu WangChen DingWenjie WuBMCarticleCervical disc arthroplastyPretic-IDiscoverAdjacent segment diseaseHeterotopic ossificationDiseases of the musculoskeletal systemRC925-935ENBMC Musculoskeletal Disorders, Vol 22, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Cervical disc arthroplasty Pretic-I Discover Adjacent segment disease Heterotopic ossification Diseases of the musculoskeletal system RC925-935
spellingShingle	Cervical disc arthroplasty Pretic-I Discover Adjacent segment disease Heterotopic ossification Diseases of the musculoskeletal system RC925-935 Yingjun Guo Hao Liu Jianzhong Xu Yuxiao Deng Xiaoliang Tao Yang Meng Xiaofei Wang Ying Hong Beiyu Wang Chen Ding Wenjie Wu Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
description	Abstract Background The 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. Methods Peri-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. Results A 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. Conclusion CDA 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.
format	article
author	Yingjun Guo Hao Liu Jianzhong Xu Yuxiao Deng Xiaoliang Tao Yang Meng Xiaofei Wang Ying Hong Beiyu Wang Chen Ding Wenjie Wu
author_facet	Yingjun Guo Hao Liu Jianzhong Xu Yuxiao Deng Xiaoliang Tao Yang Meng Xiaofei Wang Ying Hong Beiyu Wang Chen Ding Wenjie Wu
author_sort	Yingjun Guo
title	Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
title_short	Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
title_full	Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
title_fullStr	Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
title_full_unstemmed	Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
title_sort	pretic-i was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up
publisher	BMC
publishDate	2021
url	https://doaj.org/article/8e1070ab72cc40bc8bab37c81f848769
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Pretic-I was a safe and effective artificial cervical disc prosthesis--a retrospective and comparative study with 5-year follow-up

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