Naresh Kumar1,2, Zhong Jun Liu3, Wai Sang Poon4, Chun-Kun Park5,6, Ruey-Mo Lin7,8, Kyoung-Suok Cho9, Chi Chien Niu10, Hung Yi Chen11, Sirisha Madhu12, Liang Shen13, Yu Sun3, Wai Kit Mak4, Cheng Li Lin14, Sang-Bok Lee9, Choon Keun Park15, Dong Chan Lee15, Fu-I Tung11, Hee-Kit Wong12,16. 1. Department of Orthopaedic Surgery, National University Health System, Level 11, Tower Block, 1E, Lower Kent Ridge Road, Singapore, 119228, Singapore. dosksn@nus.edu.sg. 2. Department of Orthopaedic Surgery, Yong Loo Lin School of Medicine, National University of Singapore, 10 Medical Drive, Singapore, 117597, Singapore. dosksn@nus.edu.sg. 3. Orthopaedic Department and Spinal Institute, Peking University Third Hospital, Beijing, China. 4. Division of Neurosurgery, Department of Surgery, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China. 5. Kangnam St. Mary's Hospital, Seoul, South Korea. 6. Good Doctor Tntn Hospital, 775, Gyeongsu-daero, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea. 7. Orthopedics Department, National Cheng Kung University Hospital, Tainan, Taiwan. 8. Orthopedic Department, China Medical University, Taichung, Taiwan. 9. Department of Neurosurgery, Uijeongbu St. Mary's Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Republic of Korea. 10. Spine Division, Department of Orthopaedics, Chang Gung Memorial Hospital, Taoyuan City, Taiwan. 11. Taipei City Hospital, Yang Ming Branch, Shilin District, Taipei, Taiwan. 12. Department of Orthopaedic Surgery, National University Health System, Level 11, Tower Block, 1E, Lower Kent Ridge Road, Singapore, 119228, Singapore. 13. Biostatistics Unit, Yong Loo Lin School of Medicine, Clinical Research Centre, National University of Singapore, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore. 14. Spine Section, Orthopedics Department, National Cheng Kung University, Tainan, Taiwan. 15. Thomas Medical Foundation, Wiltse Memorial Hospital, Suwon-si, Republic of Korea. 16. Department of Orthopaedic Surgery, Yong Loo Lin School of Medicine, National University of Singapore, 10 Medical Drive, Singapore, 117597, Singapore.
Abstract
PURPOSE: Our study aimed to evaluate non-inferiority of ProDisc-C to anterior cervical discectomy and fusion (ACDF) in terms of clinical outcomes and incidence of adjacent segment disease (ASD) at 24-months post-surgery in Asian patients with symptomatic cervical disc disease (SCDD). METHODS: This multicentre, prospective, randomized controlled trial was initiated after ethics committee approval at nine centres (China/Hong Kong/Korea/Singapore/Taiwan). Patients with single-level SCDD involving C3-C7-vertebral segments were randomized (2:1) into: group-A treated with ProDisc-C and group-B with ACDF. Assessments were conducted at baseline, 6-weeks, 3/6/12/18/24-months post-surgery and annually thereafter till 84-months. Primary endpoint was overall success at 24-months, defined as composite of: (1) ≥ 20% improvement in neck disability index (NDI); (2) maintained/improved neurologic parameters; (3) no implant removal/revision/re-operation at index level; and (4) no adverse/severe/life-threatening events. RESULTS: Of 120 patients (80ProDisc-C,40ACDF), 76 and 37 were treated as per protocol (PP). Overall success (PP) was 76.5% in group-A and 81.8% in group-B at 24-months (p = 0.12), indicating no clear non-inferiority of ProDisc-C to ACDF. Secondary outcomes improved for both groups with no significant inter-group differences. Occurrence of ASD was higher in group-B with no significant between-group differences. Range of motion (ROM) was sustained with ProDisc-C but lost with ACDF at 24-months. CONCLUSION: Cervical TDR with ProDisc-C is feasible, safe, and effective for treatment of SCDD in Asians. No clear non-inferiority was demonstrated between ProDisc-C and ACDF. However, patients treated with ProDisc-C demonstrated significant improvement in NDI, neurologic success, pain scores, and 36-item-short-form survey, along with ROM preservation at 24-months. Enrolment difficulties resulted in inability to achieve pre-planned sample size to prove non-inferiority. Future Asian-focused, large-scale studies are needed to establish unbiased efficacy of ProDisc-C to ACDF.
PURPOSE: Our study aimed to evaluate non-inferiority of ProDisc-C to anterior cervical discectomy and fusion (ACDF) in terms of clinical outcomes and incidence of adjacent segment disease (ASD) at 24-months post-surgery in Asian patients with symptomatic cervical disc disease (SCDD). METHODS: This multicentre, prospective, randomized controlled trial was initiated after ethics committee approval at nine centres (China/Hong Kong/Korea/Singapore/Taiwan). Patients with single-level SCDD involving C3-C7-vertebral segments were randomized (2:1) into: group-A treated with ProDisc-C and group-B with ACDF. Assessments were conducted at baseline, 6-weeks, 3/6/12/18/24-months post-surgery and annually thereafter till 84-months. Primary endpoint was overall success at 24-months, defined as composite of: (1) ≥ 20% improvement in neck disability index (NDI); (2) maintained/improved neurologic parameters; (3) no implant removal/revision/re-operation at index level; and (4) no adverse/severe/life-threatening events. RESULTS: Of 120 patients (80ProDisc-C,40ACDF), 76 and 37 were treated as per protocol (PP). Overall success (PP) was 76.5% in group-A and 81.8% in group-B at 24-months (p = 0.12), indicating no clear non-inferiority of ProDisc-C to ACDF. Secondary outcomes improved for both groups with no significant inter-group differences. Occurrence of ASD was higher in group-B with no significant between-group differences. Range of motion (ROM) was sustained with ProDisc-C but lost with ACDF at 24-months. CONCLUSION: Cervical TDR with ProDisc-C is feasible, safe, and effective for treatment of SCDD in Asians. No clear non-inferiority was demonstrated between ProDisc-C and ACDF. However, patients treated with ProDisc-C demonstrated significant improvement in NDI, neurologic success, pain scores, and 36-item-short-form survey, along with ROM preservation at 24-months. Enrolment difficulties resulted in inability to achieve pre-planned sample size to prove non-inferiority. Future Asian-focused, large-scale studies are needed to establish unbiased efficacy of ProDisc-C to ACDF.
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