The effectiveness of prophylactic foraminotomy in preventing C5 palsy paralysis: a meta- analysis

doi:10.21203/rs.3.rs-1548200/v1

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The effectiveness of prophylactic foraminotomy in preventing C5 palsy paralysis: a meta- analysis

https://doi.org/10.21203/rs.3.rs-1548200/v1

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Background: With the development of medical science, surgical treatment of cervical spondylosis has increasingly achieved positive results. However, postoperative complications have also gradually increased, cervical 5 (C5) nerve root paralysis syndrome is one of the more serious complications. Different theories have been formulated regarding what causes this after posterior cervical surgery and studies have been conducted to test these theories, but no consensus has been reached.

Methods: We systematically searched the literature for studies on the clinical effect of foraminotomy on C5 nerve root palsy; our search included the MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Embase and Allied Health Literature (CINAHL) databases from their establishment to present.

Results: A total of 6 studies meeting the inclusion criteria and including 1174 patients were included in this meta-analysis: Prophylactic foraminotomy was performed in 498 patients and foraminoplasty was performed in 676 patients. There was no significant difference in the incidence of C5 palsy or the Japanese Orthopedic Association（JOA）scores between prophylactic foraminotomy and ordinary cervical spine surgery [OR = 0.67, 95% Cl (0.15,3.10), P = 0.61], [SMD = 0.15, 95% Cl(−0.06,0.36), P = 0.15]. However, the duration of prophylactic foraminotomy was longer than that of conventional cervical surgery [MD = 27.38, 95% Cl (21.73,33.02), P < 0.00001].

Conclusions: Meta-analysis results showed that prophylactic foraminotomy was not significant in preventing the incidence of C5 nerve palsy and JOA score , but prolonged the operation time Therefore, we do not recommend prophylactic foraminotomy to prevent postoperative C5 nerve root palsy in light of the current evidence.

Prophylactic foraminotomy

C5 palsy

cervical spine surgery

foraminoplasty

JOA score

In recent years, due to aging^[^] and changes in people’s lifestyles, the incidence of cervical spondylosis is increasing annually. People spend far more time sitting at work than physically active[].The current incidence rate of cervical spondylosis is 8.3 per 100,000 population, and the prevalence rate is 3.3 cases per 1000 people []. Cervical spondylosis seriously affects patients’ quality of life [^]. In our clinical practice, in addition to typical symptoms such as neck and shoulder pain, numbness or hypersensitivity of arms, and impairment of the fine-motor performance of the extremities, patients with cervical spondylosis often report such atypical symptoms as vertigo, headache, nausea, tinnitus, blurred vision, palpitation, hypomnesia, and gastrointestinal discomfort [^]. Furthermore, due to physical discomfort and related limitations in their activities, patients with cervical spondylosis experience anxiety, depression, and other mental health symptoms, which have a certain impact on their quality of life [^]. Surgery is usually recommended for patients who do not respond to conservative treatment and for trauma patients^[^], many of whom are in the productive stage of their life and are part of the community workforce. Temporary disability caused by this condition may lead to significant loss of productivity; therefore, the therapeutic effect of surgery in such cases is particularly important.

Results of a meta-analysis [] suggest that surgical treatment may be more beneficial than conservative treatment for patients with myelopathy. Laminoplasty is a routine treatment for cervical spondylosis; however, it can lead to kyphosis, which can cause a number of adverse reactions [^]. Postoperative upper limb paralysis (ULP) is a recognized complication of cervical spine surgery, also known as C5 paralysis. According to relevant research [^], of the more than 30,000 posterior cervical fusions performed annually, 7–12% of patients develop this disease characterized by newly emerging deltoid weakness, with or without C5 skin lesions and biceps weakness. As a common complication after posterior open-door spondyloplasty for cervical spondylotic myelopathy, C5 nerve root paralysis was first proposed by Scoville[] and Stoops[] in 1961. Clinically, it mostly manifests as mild paralysis of the deltoid muscle and/or the biceps brachii muscle without deterioration of the spinal cord [^]. Approximately 50% of patients experience neck and shoulder pain, and the remaining 50% hypoesthesia []. Although most patients may recover from C5 nerve root palsy within a few months [], this disease can lead to a decrease in their quality of life. Therefore, its prevention is a problem worthy of study and discussion.

Currently, there is no specific treatment method in clinical practice. However, according to the possible etiological mechanism, methods for prevention and alleviation were proposed in clinical practice, such as evaluating the size of the 4–5 foraminal foramina or the cross-sectional area of C5 nerve root by ultrasound before surgery [^], or the perioperative prophylactic use of dexamethasone [^]. Other methods include intraoperative real-time electromyography (EMG) monitoring of the nerve injury [^], avoiding excessive stretching of the muscles behind the neck for long periods of time, ] ,performing prophylactic foraminotomy if necessary [^],^[^].There are studies that show that, avoid excessive opening angle and reducing laminectomy width during the operation to reduce postoperative cervical 5 nerve root palsy[^],or using ice brine and bone drill during the operation to achieve this effect [^]. Relevant studies have shown that preoperative C4-C5 foraminal stenosis is one of the risk factors for postoperative C5 nerve root palsy [^],^[^]; therefore, intraoperative foraminal decompression at this level may reduce its incidence. However, some scholars have raised objections; according to their findings [^], prophylactic foraminotomy should be performed with caution, as prophylactic surgery may instead lead to C5 paralysis, and should be limited to patients at risk of C5 paralysis. Considering this, we conducted a meta-analysis of the relevant literature on the clinical efficacy of foraminotomy against C5 nerve root palsy to provide new ideas for diagnosis and treatment after cervical decompression.

Literature search

We systematically searched the literature in the MEDLINE, CENTRAL, Embase, and CINAHL databases and retrieved studies on the effect of foraminotomy on C5 palsy as a clinical outcome. References were retrospectively included in our search and related systematic evaluations were performed, supplemented by manual retrieval. We used the following search terms in different combinations as MeSH (Medical Subject Heading) terms and as text words: C5 palsy , postoperative upper limb palsy , nerve root injury , Cervical laminoplasty, Prophylactic foraminotomy , Foraminotomy. To identify other relevant studies, we manually scanned the references lists of the retrieved trials and review articles. Two investigators independently reviewed all the subjects, abstracts, and full texts of articles that were potentially eligible based on the abstract review. The eligible trials were then selected according to the study eligibility criteria.

Study eligibility criteria

We systematically reviewed published studies according to the following criteria: (1) subjects underwent cervical spine surgery; (2) study type: randomized controlled trial; retrospective study; (3) intervention methods: the experimental group received prophylactic foraminotomy or routine cervical surgery plus foraminotomy; the control group received routine cervical spine surgery; (4) outcome indicators: C5 nerve root palsy rate operation time and intraoperative bleeding rate, JOA score. Studies without a control group were excluded from the analysis. Any disagreement between the reviewers was resolved by discussion.

Data extraction

Two reviewers independently extracted data using standardized forms. The data were collected according to the following categories: (1) basic characteristics, including publication year, study design, number of experimental subjects and intervention methods, number of controls and control measures, and outcome indicators; (2) the incidence of C5 nerve root palsy as the primary outcome; (3) secondary outcomes, including JOA score, operative time, and intraoperative blood loss.

Methodological quality assessment

The study methodological assessment was conducted using the modified Jadad scale. This is an eight-item scale designed to assess randomization, blinding, withdrawals and dropouts, inclusion and exclusion criteria, adverse effects and statistical analysis. The score for each article could range from 0 (lowest quality) to 8 (highest quality). Scores of 4–8 denoted good to excellent quality and 0–3 poor to low quality. Critical appraisal was conducted by one reviewer and was verified by another. The Newcastle-Ottawa scale (NOS)[^27] was used for risk assessment in the retrospective studies. The NOS was based on the following three subscales: selection (four items), comparability (one item), and outcome (three items). NOS ranges were 0 to 8, and scores of 0–3, 4–6, and 7–8 were interpreted as low, moderate, and high quality, respectively, for these studies—the higher the score, the better the quality (Table 2).

Statistical analysis

Meta-analysis was performed using RevMan 5.4 software to describe continuous variables using standard mean differences (SMDs). Dichotomous variables were described using relative risk (RR), OR odds ratio (OR), and 95% confidence intervals (Cl), which were calculated for all analyses. A χ² test was used to determine whether there was heterogeneity among the studies: If there was no statistical heterogeneity (P > 0.1, I² < 50%), the fixed effects model was applied; if there was heterogeneity (P < 0.1, I² > 50%), a random effects model was used; and if the source of heterogeneity could not be determined, descriptive analysis was used. The level of meta-analysis was set at α = 0.05.

Literature retrieval results

A total of 1110 relevant studies were obtained in the preliminary examination. After layer-by-layer screening, 6 studies were finally included (including 3 randomized controlled studies (RCTs) and 3 case-control studies), including a total of 1174 patients, as shown in Figure 1.

The basic characteristics of the included studies and literature quality evaluation results are shown in Table 1. Specific evaluations of randomized controlled studies are shown in Table 2.

Table 1 General information included in the studies

Included in the study	Year published	Experimental group		Intervention methods	Control measures	Outcome indicators	Research type
Masashi Komagata [²⁸]	2004		162	Prophylactic foraminotomy	Cervical laminoplasty	①	Retrospective study
Keiichi Katsumi [²⁹]	2012	141		Combined with prophylactic foraminotomy	Cervical laminoplasty	①②③	RCT
Masayuki Ohashi [³⁰]	2014	121		Prophylactic foraminotomy	Cervical laminoplasty	①②③④	RCT
HiroYuki Ishiguro [³¹]	2020	19		Combined with prophylactic foraminotomy	Cervical laminoplasty	①②③④	Retrospective study
Yoshihito Yamasaki [³²]	2021	15		Prophylactic foraminotomy	Cervical laminoplasty	①④	RCT
Dong-Ho Lee [^33]	2017	40		Combined with prophylactic foraminotomy	Cervical laminoplasty	④	Retrospective study

①Incidence of C5 paralysis ② Duration of operation ③Intraoperative blood loss ④JOA score

Table 2 Quality evaluation of the included literature

Items assessed		Keiichi Katsumi [24]		Masayuki Ohashi [25]		Yoshihito Yamasaki [27]
Was the study described as randomized?		Yes		Yes		Yes
Was the method of randomization appropriate?		Not described		Not described		Yes
Was the study described as blinded?		No		No		No
Was the method of blinding appropriate?		Not described		Not described		Not described
Was there a description of withdrawals and dropouts?		Yes		Yes		Yes
Was there a clear description of the inclusion/exclusion criteria?		Yes		Yes		Yes
Was the method used to assess adverse effects described?		Yes		Yes		Yes
Was the method of statistical analysis described?		Yes		Yes		Yes
Scores		5		5		6


	Masashi Komagata [23]		HiroYuki Ishiguro [26]		Dong-Ho Lee [28]
Representativeness of the exposed cohort	Yes		Yes		Yes
Selection of the unexposed cohort	Yes		Yes		Yes
Ascertainment of exposure	Yes		Yes		Yes
Outcome of interest not present at start of study	Yes		Yes		Yes
Control for important factors or additional factors	Yes		Yes		Yes
Outcome assessment	Yes		Yes		Yes
Follow-up long enough for outcomes to occur	Yes		Yes		Yes
Adequacy of follow-up of cohorts	No		No		Yes
Total quality score	7		7		8

Meta-analysis results

Incidence of C5 paralysis

The effect of prophylactic foraminotomy on the rate of C5 nerve root paralysis was reported in 5 studies involving 650 subjects. The meta results showed large heterogeneity (P = 0.0005, I² = 80%). Using a random-effect model, meta-analysis showed that there was no significant difference in the incidence of C5 paralysis between preventive foraminotomy and normal cervical spine surgery [OR = 0.67,95% Cl (0.15,3.10), P = 0.61] (Figure 2).

The operation times

The effect of prophylactic foraminotomy on the duration of surgery was reported in 3 studies. A total of 332 patients were included with small heterogeneity (P = 0.36, I² = 2%). Meta-analysis using a fixed-effect model showed that the surgery duration of preventive foraminotomy was longer than that of normal cervical spine surgery, and the difference was statistically significant [MD = 27.38, 95% Cl (21.73,33.02), P < 0.00001] (Figure 3).

Intraoperative blood loss

The effect of preventive foraminotomy on intraoperative blood loss was reported in 3 studies. A total of 332 cases were included with small heterogeneity of the subjects (P = 0.34, I² = 7%). Meta-analysis using a fixed-effect model showed no significant difference in the intraoperative blood loss between preventive foraminotomy and common cervical surgery [SMD = −0.07, 95% Cl (−0.23,0.09), P = 0.41] (Figure 4).

JOA scores

The effect of prophylactic foraminotomy on dysfunction was reported in 3 studies involving 227 subjects. Literature heterogeneity was small (P = 0.38, I² = 0%). Meta-analysis using a fixed-effect model showed no statistically significant difference in the JOA scores between preventive foraminotomy and common cervical surgery [SMD = 0.15, 95% Cl (−0.06,0.36), P = 0.15] (Figure 5).

Sensitivity analysis

Sensitivity analysis was performed by excluding individual studies one by one. The results showed that the main source of heterogeneity was HiroYuki’s study[31]. The possible reason for the heterogeneous results is that the subjects in this study had cervical spondylotic radiculopathy, while the subjects in the other 5 studies had cervical spondylotic myelopathy. The difference was not statistically significant after the exclusion of this study [OR = 0.39, 95% CI (0.10, 1.54), P = 0.04]. The meta-analysis results did not change, suggesting that the results were stable (Figure 6).

Publication bias

A funnel plot was drawn for the C5 paralysis rate outcome index to test publication bias, and the results showed that the left and right distributions of each study point were symmetrical, suggesting that there might be a low publication bias (Figure 7).

The 6 studies included in this review [10–15] all carried out a baseline consistency analysis of the general information of the research objects, and their experimental and control groups were comparable. The methodological quality evaluation of the included literature was generally high, ensuring a certain reference value for clinical practice.

C5 nerve root palsy is a common complication of cervical spine surgery whose specific mechanism is not yet clear [^]. Although foraminal stenosis has been shown to be an important risk factor in this regard [^], whether it can be prevented by intervertebral foramen cut remains without clear confirmation, as researchers have discussed.

Katsumi reported that prophylactic bilateral C4-C5 foraminal decompression can significantly reduce the incidence of C5 nerve root palsy, while other scholars have argued to the contrary. According to Bydon’s findings [18], foraminotomy can be a cause. The incidence of C5 nerve root palsy increased from 11.6–14.5% in patients undergoing preventive posterior foraminotomy, which may be related to the nerve injury caused by local hyperosteogeny after foraminotomy and the injury of foraminal stenosis itself.

The results of this meta-analysis suggest that preventive foraminotomy is not effective in preventing postoperative C5 nerve root palsy, so preventive foraminotomy is not recommended as a routine procedure in clinical cervical spine surgery. Of course, the efficacy of foraminotomy cannot be objectively evaluated due to the small number of RCTs included, and the results of this study should be corroborated and extended in future research.

Imaging findings of C4-C5 foraminal stenosis should be considered a high-risk factor for postoperative C5 nerve root palsy, with additional indications of decompression by nerve root canal incision. For patients without root symptoms and signs before surgery or foraminal stenosis on imaging, foraminal incision is not required. Some scholars suggest that foraminal decompression is not required routinely except for patients with preoperatively confirmed foraminal stenosis and corresponding clinical manifestations of nerve root compression ^[^]. The cervical spine surgeons should step up to the importance of the complications, according to the variety of possible risk factors, by perfecting the preoperative assessment of compression degree of the spinal cord lesions; strictly grasping the decompression surgical indications, establishing reasonable decompression surgery, and aiming to carry out preventive measures, such as intervertebral foramen incision, are expected to a certain extent to reduce the occurrence of C5 nerve root palsy [21].

The limitations of this study include the fact that different types of spinal disease in patients enrolled in different studies may bias the results of preventive foraminotomy, and that the number of included studies and the sample size of some studies was also small, with only 3 RCTs [10,11,14].

In summary, current evidence suggests that preventive foraminotomy makes no significant difference in reducing the incidence of C5 nerve root palsy and improving neurological function in patients after cervical spine surgery compared with ordinary cervical surgery. Limited by the quality of the included studies, these conclusions need to be further verified by large-sample, high-quality RCTs.

RCTs = randomized controlled trials

JOA scores=Japanese Orthopedic Association scores

CI = confidence interval

NOS=The Newcastle-Ottawa scale

Authors’ contributions

XY carried out the entire procedure including the literature search, data extraction, performed the statistical analysis, drafted the manuscript, revised submitted the manuscript. ZLY conceived of the study, coordinated and participated in the entire process of drafting and revised the manuscript. All authors read and approved the final manuscript.

Funding

The authors have no financial support to declare.

Availability of data and materials

All data generated or analysed during this study are included in this published article. Additional information may be requested directly from the study authors.

Ethics approval and consent to participate

This article does not contain any studies with human or animal subjects performed by any of the authors.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Acknowledgements

We wish to express our warm thanks to all the authors who have contributed to the study.And we would like to thank Editage (www.editage.cn) for English language editing.

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No competing interests reported.

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The effectiveness of prophylactic foraminotomy in preventing C5 palsy paralysis: a meta- analysis

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