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Cervical disc arthroplasty improved outcomes vs. anterior cervical discectomy and fusion
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July 2016
Cervical disc arthroplasty improved outcomes vs. anterior cervical discectomy and fusion
Study Type:Meta-analysis/Systematic Review
OE Level Evidence:1
Journal Level of Evidence:N/A
Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials
PLoS One. 2016 Feb 12;11(2):e0149312Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
8 randomized controlled trials comparing cervical disc arthroplasty (CDA) to anterior cervical discectomy and fusion (ACDF), for the treatment of symptomatic cervical disc disease (1-level or 2-level), were included. The purpose of this study was to assess the safety and efficacy of these procedures at a minimum of 48 months, through a quantitative analysis of available literature. The results indicated that patients receiving CDA displayed higher rates of overall success, Neck Disability Index success, neurological success, and lower rates of serious treatment-related adverse events and secondary procedures when compared to ACDF patients. Functional results, patient satisfaction and the incidence of superior adjacent level degeneration were significantly better in the CDA group as well.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
China Scholarship Council
Conflicts:
None disclosed
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
4/4
Introduction
4/4
Accessing Data
2/4
Analysing Data
4/4
Results
2/4
Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Anterior cervical discectomy and fusion (ACDF) is the standard treatment for radiculopathy and myelopathy caused by disc disease. Potential drawbacks to this procedure include pseudarthrosis and adjacent segment degeneration. Cervical disc arthroplasty (CDA) is an alternative technique that has been introduced to potentially avoid adjacent segment degeneration, as it has previously been shown to maintain segmental range of motion and cervical kinematics. However, this treatment is associated with its own adverse effects, and previous studies comparing CDA and ACDF have led to inconclusive results. The present study was conducted to clarify whether CDA provides beneficial neurological outcomes and reduced the risk of adjacent segment degeneration by quantitatively assessing the available body of evidence.
What was the principal research question?
How did the mid- to long-term efficacy and safety of cervical disc arthroplasty compare to anterior cervical discectomy and fusion, in the treatment of 1- or 2-level symptomatic cervical disc disease?
Study Characteristics
-
Data Source:
A computerized database search was conducted using Medline, Embase, and the Cochrane Central Register of Controlled Trials, for studies published in English, up to January 2016. Reference lists of selected studies and relevant reviews were also assessed.
Index Terms:
Search terms included: "cervical disc arthroplasty", "fusion", "arthrodesis", and "randomized controlled trial".
Study Selection:
Inclusion criteria were prospective randomized controlled trials (RCTs) comparing CDA with ACDF, with a minimum of 48-month follow-up; a patient group older than 18 years of age with 1-level or 2-level symptomatic cervical disc disease and unresponsive to non-operative treatment for at least 6 weeks; and studies reporting at least 1 desirable outcome. Two independent reviewers assessed articles for adherence to inclusion criteria and disagreements were resolved via discussion and consensus. 8 studies were included (n=2368; 1317 CDA patients; 1051 ACDF patients).
Data Extraction:
Two independent reviewers extracted data. Outcomes included overall success, neurological success, Neck Disability Index (NDI) success, patient satisfaction & recommendation, implant/surgery-related serious adverse events, secondary procedure, NDI, neck and arm pain scores, the Short Form 36 Health Survey physical component score (SF-36 PCS), and adjacent segment degeneration.
Data Synthesis:
Meta-analyses were conducted using Review Manager (Version 5.3). Dichotomous variables were expressed as relative risk (RR) and continuous variables were expressed as weighted mean difference (WMD), both with corresponding 95% confidence intervals (CIs). Heterogeneity was assessed using the chi-square test and Higgin's I2 test, significance (p<0.10 or I2>50%) dictated the use of a random effects model, otherwise a fixed-effects model was used. Subgroup analyses were performed for patients with 1-level cervical disc disease. Significance was set at p<0.05.
What were the important findings?
- Overall success (NDI success, neurological success, absence of implant/surgery-related serious adverse events and secondary procedures) was significantly greater in the CDA group when compared to the ACDF group (2 studies; 714 patients; RR 1.17 [95% CI 1.07, 1.28]; I2=0%; p=0.0005) as was NDI success (15 point increase) (3 studies; 999 patients; RR 1.10 [95% CI 1.04, 1.18]; I2=17%; p=0.002)
- Neurological success was significantly greater in the CDA Group vs. the ACDF group (6 studies; 1671 patients; RR 1.04 [95% CI 1.01, 1.08]; I2=9%; p=0.01)
- Implant/surgery-related serious adverse events were comparable between groups (4 studies; 1201 patients; RR 0.62 [95% CI 0.39, 1.01]; I2=0%; p=0.05). Secondary procedures were significantly less common in the CDA group (7 studies; 2037 patients; RR 0.55 [95% CI 0.42, 0.73]; I2=29%; p<0.0001). These results were confirmed in the 6 and 4 studies assessing secondary procedures at the index level and at the adjacent level, respectively.
- In terms of functional scores, significantly better scores were noted in the CDA group with respect to NDI scores (3 studies; p<0.00001), neck pain (2 studies; p<0.0001), arm pain (2 studies; p=0.05), and SF-36 PCS (2 studies; p=0.002). As well, the CDA group displayed greater overall improvements in NDI score, neck pain, and SF-36 PCS, and favourable but nonsignificant arm pain scores.
- Patient satisfaction was significantly greater in the CDA group (3 studies; 829 patients; RR 1.09 [95% CI 1.03, 1.16]; I2=0%; p=0.002), as was patient recommendation (3 studies; 829 patients; RR 1.10 [95% CI 1.05, 1.16]; I2=0%; p=0.0004) compared to the ACDF group
- Significantly less superior adjacent level degeneration was noted in the CDA group (2 studies; p<0.0001) and no differences were noted between groups in terms of the incidence of inferior adjacent level degeneration (2 studies; p=0.09)
What should I remember most?
Patients receiving cervical disc arthroplasty displayed higher rates of overall success, Neck Disability Index success, neurological success, and lower rates of serious adverse events and secondary procedures when compared to anterior cervical discectomy and fusion. Functional results were significantly better in the CDA group, as was patient satisfaction, and the incidence of superior adjacent level degeneration was significantly lower in the CDA group.
How will this affect the care of my patients?
The results of this meta-analysis displayed that the mid- to long-term success rates, functional outcomes, adverse events, secondary procedures, patient satisfaction, and the incidence of superior adjacent level degeneration was significantly better in the patients receiving cervical disc arthroplasty when compared to patients receiving anterior cervical discectomy and fusion for symptomatic cervical disc disease. However, a number of these outcomes were only assessed in a few studies and should be interpreted with caution. Additionally, while these results support the use of cervical disc arthroplasty, cost-effectiveness analyses are needed before this treatment can be recommended over anterior cervical discectomy and fusion.
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