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ProDisc–C versus anterior cervical discectomy and fusion for the surgical treatment of symptomatic cervical disc disease: two-year outcomes of Asian prospective randomized controlled multicentre study

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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.

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Acknowledgements

We would like to acknowledge the administrative support provided by Keith Gerard Lopez, Sridharan Alathur Ramakrishnan, and Dr Nandika Naresh for the development of the manuscript.

Funding

The study was sponsored by DePuy Synthes. The sponsor had no role in the conduction of the study or the compilation of the study report/manuscript.

Author information

Author notes

  1. Chun-Kun Park

    Present address: Good Doctor Tntn Hospital, 775, Gyeongsu-daero, Dongan-gu, Anyang-si, Gyeonggi-do, South Korea

  2. Ruey-Mo Lin

    Present address: Orthopedic Department, China Medical University, Taichung, Taiwan

Authors and Affiliations

  1. Department of Orthopaedic Surgery, National University Health System, Level 11, Tower Block, 1E, Lower Kent Ridge Road, Singapore, 119228, Singapore

    Naresh Kumar, Sirisha Madhu & Hee-Kit Wong

  2. Orthopaedic Department and Spinal Institute, Peking University Third Hospital, Beijing, China

    Zhong Jun Liu & Yu Sun

  3. Division of Neurosurgery, Department of Surgery, Faculty of Medicine, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China

    Wai Sang Poon & Wai Kit Mak

  4. Kangnam St. Mary’s Hospital, Seoul, South Korea

    Chun-Kun Park

  5. Orthopedics Department, National Cheng Kung University Hospital, Tainan, Taiwan

    Ruey-Mo Lin

  6. Department of Neurosurgery, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Republic of Korea

    Kyoung-Suok Cho & Sang-Bok Lee

  7. Spine Division, Department of Orthopaedics, Chang Gung Memorial Hospital, Taoyuan City, Taiwan

    Chi Chien Niu

  8. Taipei City Hospital, Yang Ming Branch, Shilin District, Taipei, Taiwan

    Hung Yi Chen & Fu-I Tung

  9. Biostatistics Unit, Yong Loo Lin School of Medicine, Clinical Research Centre, National University of Singapore, Block MD11, 10 Medical Drive, Singapore, 117597, Singapore

    Liang Shen

  10. Spine Section, Orthopedics Department, National Cheng Kung University, Tainan, Taiwan

    Cheng Li Lin

  11. Thomas Medical Foundation, Wiltse Memorial Hospital, Suwon-si, Republic of Korea

    Choon Keun Park & Dong Chan Lee

  12. Department of Orthopaedic Surgery, Yong Loo Lin School of Medicine, National University of Singapore, 10 Medical Drive, Singapore, 117597, Singapore

    Naresh Kumar & Hee-Kit Wong

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  1. Naresh Kumar
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Corresponding author

Correspondence to Naresh Kumar.

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The study was conducted after receiving approval from the Institutional Review Board or Ethics Committee at each of the nine study centres.

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Kumar, N., Liu, Z.J., Poon, W.S. et al. ProDisc–C versus anterior cervical discectomy and fusion for the surgical treatment of symptomatic cervical disc disease: two-year outcomes of Asian prospective randomized controlled multicentre study. Eur Spine J 31, 1260–1272 (2022). https://doi.org/10.1007/s00586-021-07055-0

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  • DOI: https://doi.org/10.1007/s00586-021-07055-0

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