Comparison of outcomes between Zero-p implant and anterior cervical plate interbody fusion systems for anterior cervical decompression and fusion: a systematic review and meta-analysis of randomized controlled trials

Zhang, Tingxin; Guo, Ning; Gao, Gang; Líu, Hao; Li, Yanhong; Gao, Feng; Zhang, Qingxin; Tao, Xiaoyang; Yang, Wupeng; Wang, Yongjiang

doi:10.1186/s13018-022-02940-w

Cited by 15 publications

(12 citation statements)

References 32 publications

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“…In addition, a systematic review of anterior cervical spine surgery had reported dysphagia-related occurrences of up to 5.3% [ 17 ]. There was a systematic review, and meta-analysis illustrated that ACDF with zero-profile fixation was better than anterior cervical plate fixation regarding the incidence of postoperative dysphagia (P < 0.05), which further demonstrates the robustness of our study and substantiates the distinctive benefits of Zero-P fixation in mitigating postoperative dysphagia [ 18 ]. However, an alternate review reported no significant difference in dysphagia incidence between ACDF with and without anterior plate fixation, suggesting the need for more studies to elucidate the factors influencing dysphagia [ 19 ].…”

Section: Discussionsupporting

confidence: 67%

Anterior cervical discectomy and fusion with a zero-profile VA spacer device: a clinical and radiological study with two-year follow-up

Zhao,

Xu,

Wang

et al. 2024

J Orthop Surg Res

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Study design A retrospective study. Objective The aim of this study was to compare clinical and radiological outcomes of the anterior cervical discectomy and fusion (ACDF) with a novel zero-profile variable-angle (Zero-P VA) spacer and a traditional poly-ether-ether-ketone (PEEK) cage and plate system in cases pertaining to cervical radiculopathy/myelopathy. Summary of background data There are two conventional types of ACDF procedures aimed at treating symptomatic cervical spondylosis. The first one involves an uninstrumented “stand-alone” approach utilizing bone graft/cage, while the second incorporates bone graft/cage in conjunction with a front plate positioned before the vertebral bodies. Both procedures have their own inherent advantages and disadvantages. The Zero-P VA spacer, however, represents a unique synthesis by amalgamating the advantages of both traditionally typical procedures. Notably, this spacer can potentially circumvent the issue related to prevertebral soft-tissue disturbance and reduce the occurrence of dysphagia. Methods Using our surgical database, the authors systematically conducted a retrospective analysis encompassing all patients who underwent single-level ACDF between January 2018 and January 2019, with a minimum two-year follow-up. Patients either received a Zero-P VA implant or PEEK cage coupled with plating. The Japanese Orthopedic Association (JOA) score and Visual Analogue Scale (VAS) for arm and neck pain were documented. Dysphagia was evaluated using the Eating Assessment Tool-10 (ETA-10). Additional parameters such as cervical alignment, fusion rate and the incidence of postoperative complications were assessed. Results According to the outcomes of the statistical analysis, there was no substantial disparity that emerged in the advancements observed in the JOA and VAS metrics between the two study cohorts. Noteworthy, however, the ETA-10 scores were statistically significantly reduced in the Zero-P VA group compared to the cage and plating group (p < 0.05). At the final follow-up, there were no statistically significant differences in the height of the operated segment, Cobb angle of the fused segment, C2–C7 Cobb angle and fusion rate between the two groups (p > 0.05). However, postoperative complications were slightly lower in patients with the Zero-P VA group (7.69%) as compared to the cage and plating group (16.67%). Conclusion The clinical outcomes observed with the Zero-P VA spacer used for single-level ACDF were found to be satisfactory. The performance of this device is comparable or even superior to the traditional cage and plating method in preventing postoperative dysphagia and mitigating potential complications associated with the use of a plate.

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Section: Discussionsupporting

confidence: 67%

Anterior cervical discectomy and fusion with a zero-profile VA spacer device: a clinical and radiological study with two-year follow-up

Zhao,

Xu,

Wang

et al. 2024

J Orthop Surg Res

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“…There was no anterior plating performed, which is common in European countries but differs from countries such as the US. One could argue that this influenced our results; however, systematic reviews and meta-analyses of studies on fusion found no clinical benefit from the use of additional plating …”

Section: Discussionmentioning

confidence: 81%

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year

et al. 2023

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ImportanceThe choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial.ObjectiveTo investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year.Design, Setting, and ParticipantsThis multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior).InterventionsPatients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion.Main Outcomes and MeasuresPrimary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections.ResultsAmong 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, −0.11 percentage points; 1-sided 95% CI, −0.01) and the between-group difference in arm pain was −2.8 (1-sided 95% CI, −9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences.Conclusions and RelevanceIn this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making.Trial RegistrationNetherlands Trial Register Identifier: NTR5536

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“…Furthermore, the procedure for Z-P implantation has a reduced operation time and decreased dysphagia incidence post-operatively compared to plating [ 28 ]. The reasoning behind this is that inserting the Z-P device reduces oesophageal stimulation and thus reduces the risk of oesophageal oedema and adhesions [ 29 , 30 ]. As anterior plating is not routinely performed in the spinal centre in Northern Ireland, it would be unjust to comment on our experience with this particular procedure and compare it against Z-P or Cage implants.…”

Section: Discussionmentioning

confidence: 99%

A Retrospective Evaluation and Review of Radiographic Outcomes for Anterior Cervical Discectomy and Fusion (ACDF) Procedures: Northern Ireland's Experience

McKee¹,

Espey²,

O'Halloran³

et al. 2023

Cureus

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Introduction Anterior Cervical Discectomy and Fusion (ACDF) is the gold standard treatment for symptomatic cervical spondylosis refractory to analgesic medical management. Currently, there are numerous approaches and devices used; however, there is no single implant that is preferred for this procedure. The aim of this study is to evaluate the radiological outcomes of ACDF procedures performed in the regional spinal surgery centre in Northern Ireland. The results of this study will aid surgical decision-making, specifically with regard to the choice of implant. The implants that will be assessed in this study are the stand-alone polyetheretherketone (PEEK) cage (Cage) and the Zero-profile augmented screw implant (Z-P). Methods A total of 420 ACDF cases were reviewed retrospectively. Following exclusion and inclusion criteria, 233 cases were reviewed. In the Z-P group, there were 117 patients, with 116 in the Cage group. Radiographic assessment was carried out at the pre-operative stage, day one post-operation, and follow-up (> three months). Measured parameters included segmental disc height, segmental Cobb angle, and spondylolisthesis displacement distance. Results Patient characteristic features showed no significant difference between the two groups (p>0.05) and no significant difference in mean follow-up time (p=0.146). The Z-P implant was superior in increasing and maintaining disc height post-operatively (+0.4±0.94mm, 5.20±0.66mm) compared to the Cage (+0.1±1.00mm, 4.40±0.95mm) (p<0.001). Z-P was also more successful in restoring and maintaining cervical lordosis in comparison to the Cage group, as it had a significantly smaller kyphosis incidence (0.85% vs. 34.5%) at follow-up (p<0.001). Conclusions Results of this study show a more advantageous outcome in the Zero-profile group as it restores and maintains both disc height and cervical lordosis; it is also more successful in treating spondylolisthesis. This study advocates cautious endorsement of the use of the Zero-profile implant in ACDF procedures for symptomatic cervical disc disease.

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Comparison of outcomes between Zero-p implant and anterior cervical plate interbody fusion systems for anterior cervical decompression and fusion: a systematic review and meta-analysis of randomized controlled trials

Cited by 15 publications

References 32 publications

Anterior cervical discectomy and fusion with a zero-profile VA spacer device: a clinical and radiological study with two-year follow-up

Anterior cervical discectomy and fusion with a zero-profile VA spacer device: a clinical and radiological study with two-year follow-up

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year

A Retrospective Evaluation and Review of Radiographic Outcomes for Anterior Cervical Discectomy and Fusion (ACDF) Procedures: Northern Ireland's Experience

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