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Article: 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
Title | 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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Authors | |
Keywords | Anterior cervical discectomy and fusion Cervical disc disease ProDisc-C Randomized controlled trial Total disc replacement |
Issue Date | 1-May-2022 |
Publisher | Springer |
Citation | European Spine Journal, 2022, v. 31, n. 5, p. 1260-1272 How to Cite? |
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. |
Persistent Identifier | http://hdl.handle.net/10722/338833 |
ISSN | 2021 Impact Factor: 2.721 2020 SCImago Journal Rankings: 1.448 |
DC Field | Value | Language |
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dc.contributor.author | Kumar, N | - |
dc.contributor.author | Liu, ZJ | - |
dc.contributor.author | Poon, WS | - |
dc.contributor.author | Park, CK | - |
dc.contributor.author | Lin, RM | - |
dc.contributor.author | Cho, KS | - |
dc.contributor.author | Niu, CC | - |
dc.contributor.author | Chen, HY | - |
dc.contributor.author | Madhu, S | - |
dc.contributor.author | Shen, L | - |
dc.contributor.author | Sun, Y | - |
dc.contributor.author | Mak, WK | - |
dc.contributor.author | Lin, CL | - |
dc.contributor.author | Lee, SB | - |
dc.contributor.author | Park, CK | - |
dc.contributor.author | Lee, DC | - |
dc.contributor.author | Tung, FI | - |
dc.contributor.author | Wong, HK | - |
dc.date.accessioned | 2024-03-11T10:31:53Z | - |
dc.date.available | 2024-03-11T10:31:53Z | - |
dc.date.issued | 2022-05-01 | - |
dc.identifier.citation | European Spine Journal, 2022, v. 31, n. 5, p. 1260-1272 | - |
dc.identifier.issn | 0940-6719 | - |
dc.identifier.uri | http://hdl.handle.net/10722/338833 | - |
dc.description.abstract | <p>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.</p> | - |
dc.language | eng | - |
dc.publisher | Springer | - |
dc.relation.ispartof | European Spine Journal | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Anterior cervical discectomy and fusion | - |
dc.subject | Cervical disc disease | - |
dc.subject | ProDisc-C | - |
dc.subject | Randomized controlled trial | - |
dc.subject | Total disc replacement | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s00586-021-07055-0 | - |
dc.identifier.scopus | eid_2-s2.0-85126721959 | - |
dc.identifier.volume | 31 | - |
dc.identifier.issue | 5 | - |
dc.identifier.spage | 1260 | - |
dc.identifier.epage | 1272 | - |
dc.identifier.eissn | 1432-0932 | - |
dc.identifier.issnl | 0940-6719 | - |