How Do You Know if Your Acdf Implant Didnt Take

Abstract

Purpose

Inductive cervical discectomy and fusion (ACDF) has proven constructive in treating radicular arm pain. Mail service-operatively, cervical spine stability is temporarily challenged, just information on bony fusion and speed of fusion are ambiguous; optimum evaluation method and criteria are debated.

Aim

To report bony fusion accomplishment and to obtain an overview of methods to evaluate fusion.

Methods

A literature search was performed in PubMed and Embase. Included studies had to written report original data apropos one- or 2-level ACDF with intervertebral device or bone graft, where bony fusion was assessed using CT scans or Ten-rays.

Results

A total of 146 articles comprising 10,208 patients were included. Bony fusion was more often than not defined as "the presence of trabecular bridging" and/or "the absence of move". Fusion was achieved in 90.ane% of patients at the last follow-up. No gilded standard for assessment could be derived from the results. Addition of plates and/or cages with screws resulted in slightly higher accomplishment of fusion, but differences were not clinically relevant. Eighteen studies correlated clinical outcome with bony fusion, and 3 found a significant correlation betwixt achievement and better clinical event.

Conclusions

In approximately xc% of patients, bony fusion is accomplished ane year after ACDF. As there is no generally accepted definition of bony fusion, different measuring techniques cannot exist compared to a aureate standard and it is impossible to determine the nearly accurate method. Variations in study pattern hamper conclusions on optimising the charge per unit of bony fusion by pick of material and/or additives. Insufficient attention is paid to correlation betwixt bony fusion and clinical outcome.

Graphical abstract

These slides can be retrieved from electronic supplementary material.

Introduction

Anterior cervical discectomy and fusion (ACDF) is a commonly used procedure to decompress cervical spinal fretfulness or the cervical medulla. The "discectomy" refers to the removal of the intervertebral disc including the herniated part to provide decompression of the nervous tissue. The "fusion" part refers to the additional surgical procedure to stabilize the two adjacent vertebrae which will, theoretically, be compromised afterwards removing the intervertebral disc. In order to provide surgical fusion, information technology is usual care to place an intervertebral device, like a bone graft or a cage, between the vertebra to supplant the disc tissue and to maintain foraminal peak. This procedure can be accompanied by anterior plating, which is assumed to add to the stability of the spine. Subsequent "bony fusion" is deemed to follow upon consolidation of the bone between the adjacent vertebrae through and along the intervertebral device. The intervention is regarded to lead to solid arthrodesis and to carry minimal surgical risks [i,2,3]. It is slightly confusing that "surgical fusion" and "bony fusion" are in general both referred to every bit "fusion".

Autologous iliac os grafts too every bit cages made from titanium, polyether ether ketone (PEEK) and diverse other materials are normally used as intervertebral devices. Although cages tin differ in shape and material, they are all intended to maintain height and to add to immobilization of the degenerated move segment [4].

Business firm immobilization is merely effectuated once bony fusion has been accomplished. Anterior discectomy temporarily challenges the stability of the cervical spine mail-operatively, and this tin can theoretically atomic number 82 to kyphotic malalignment [5], which tin can give rise to cervix disability and pain and, ultimately, to neurological deficits. In order to avert these complications, patients' daily activities are restricted until bony fusion has been achieved.

However, knowledge nearly the process of bony fusion is express. Firstly, it is debated what the timing of bony fusion is subsequently a discectomy was carried out. Secondly, the method to judge bony fusion is non equivocal. Finally, the correlation betwixt bony fusion and clinical outcome is unknown.

The primary objective of this systematic review is to study the process of bony fusion and to obtain an overview of methods to evaluate bony fusion. Secondary objectives are to compare results based on evaluation methodology, cage or graft textile and addition of bone stimulating agents, and to assess whether there is a correlation between clinical effect and bony fusion accomplishment.

Methods

Data searches and study selection

To obtain all relevant literature, the electronic databases PubMed and Embase were searched on 14 Jan 2016. The search strings presented in Tabular array 1 were used. Co-ordinate to PRISMA guidelines, ii of the authors (IN and MTK) individually and independently screened the articles for predefined inclusion criteria. These were stated equally follows:

Table 1 Search strings used for the data search in January 2016

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• The article was published in English or Dutch;

• The article was an original report presenting primary data;

• The commodity was published on or after 1 Jan 2000;

• The study had a minimum of 10 patients;

• The study focused on the cervical spine (C2-Th1);

• The study presented patients undergoing a 1- or 2-level inductive cervical discectomy and fusion with an intervertebral device (exempting prostheses) or a bone graft;

• The included patients did non undergo revision surgery or surgery equally treatment for trauma;

• The method of assessing fusion was described;

• The report assessed fusion with CT scan or X-ray;

• The commodity was published in a peer-reviewed journal.

Only studies that the evaluators reached a consensus on were included. If needed, a third reviewer (CVL) was consulted.

Quality assessment

To assess the quality of the selected studies, the studies were evaluated with the aid of an adjusted version of the Dutch Cochrane Center checklist for cohort studies, presented in Table ii. The methodological requirements and objectives of these studies were closely evaluated. This was done individually and independently by 2 reviewers (IN and CVL). Studies were assessed on selection bias, outcome bias and follow-upward bias, each category accounting for a maximum of 3 points. In total, a study could be awarded a maximum of nine points. Studies were so divided into a low (five–9 points) or high (four or less points) risk of bias group using a method adjusted from Furlan et al. [vi].

Tabular array 2 Quality assessment checklist

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Data extraction

All data from the included studies were analysed, and data regarding the following items were extracted:

• Number of participating patients;

• Mean fourth dimension and range of follow-up;

• Pct of fusion at three, 6, 12 and 24 months and at last follow-up;

• Method of measuring bony fusion;

• Use of os growth stimulation;

• Distribution of patients over different implant types;

• Apply of plate and/or screws;

• Clinical outcome and correlation to bony fusion;

• Contact area and height of the implant.

Statistical analysis

Descriptive analyses were performed using paired t-tests, and dichotomous data were analysed using Chi-foursquare tests with Yates' correction. P values of less than or equal to 0.05 were considered statistically meaning.

Clinical relevance was assessed using the method described past Ostelo et al. [7], who defined absolute cut-off values for multiple clinical outcome measures and proposed a minimal clinically important divergence (MCID) as an improvement of thirty% or more than in respect of the baseline value as a general rule.

Results

Characteristics of included studies

Through our search, 1421 unique studies were identified. Later on matching these to our inclusion criteria, 146 studies were included. The most common grounds to exclude studies were as follows: patients did not undergo ACDF, bony fusion was not properly described, and patient numbers were also modest, as shown in Fig. 1.

Fig. 1

Flow chart of excluding studies. ACDF anterior cervical discectomy and fusion

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Combining all studies resulted in a accomplice of 10,208 patients, of whom 3200 received a os graft (including allogenic and autologous bone), 4671 received a polyether ether ketone (PEEK) cage, 348 received a poly(methyl methacrylate) (PMMA) cage, 239 received a carbon fibre muzzle, and 1750 received a titanium muzzle (Fig. 2).

Fig. 2

Distribution of implants over patients. PEEK polyether ether ketone. PMMA poly(methyl methacrylate)

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Take a chance of bias

A total of 119 studies were assessed to take a low risk of bias, and 27 studies showed a loftier take a chance of bias. When comparing studies with a depression and high risk of bias, the difference mainly seems to exist due to outcome and follow-upwardly bias, since studies with a loftier take chances of bias by and large did not separate follow-up into multiple moments in fourth dimension and did not investigate the correlation between clinical outcome and bony fusion.

Bony fusion

Among many other definitions, bony fusion was most usually divers every bit the presence of trabecular bridging on X-rays or CT scans and/or absence of motion on flexion/extension radiographs. Realization of bony fusion was mostly reported at the final follow-up moment (FFU). The median fourth dimension to FFU was 20.5 months, with a range of iii–408 months. At FFU, studies report accomplished bony fusion in a mean of 90.one% of patients, ranging from i study reporting 30% [viii] to studies reporting 100% [9,ten,11,12,xiii,14,fifteen,16,17,xviii,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,xl,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67]. Studies with a high risk of bias reported statistically significantly higher numbers of patients in which bony fusion was accomplished than studies with a low risk of bias (94.0% and 89.4%, respectively; p < 0.0001). The rate of bony fusion (accomplishment of fusion in a particular patient over time) was studied in approximately one-half of the included manufactures, in which accomplishment of bony fusion was measured at three, vi, 12 and 24 months follow-up (Table iii, Fig. 3) [4, 8,9,10,11, thirteen, 15,16,17, 20, 21, 23,24,25, 27, 30,31,32, 34, 38, 40,41,42, 45, 47,48,49,fifty,51, 54, 55, 57, 59,60,61,62,63,64,65, 67,68,69,lxx,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,xc,91,92,93,94,95,96,97]. Significantly college bony fusion accomplishment rates are observed subsequently longer periods of follow-upwards; however, the difference in accomplishment of bony fusion betwixt 12 months and 24 months follow-up is non clinically relevant.

Table three Fusion rate over time

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Fig. 3

Fusion rate over time

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Methods of measuring bony fusion

Trabecular bridging as a sign of achievement of bony fusion was determined in 26 studies evaluating CT scans and in 63 studies evaluating apparently antero-posterior and/or lateral 10-rays. Motion on lateral flexion/extension X-rays as a sign of achievement of bony fusion was determined in 55 studies. In 17 studies, the angulation changes at the target level were measured, and in 11 studies, the difference in interspinous distances upon flexion and deflexion was measured. In 27 studies, the method was not further divers. At FFU, bony fusion was accomplished in 90.1% of patients in studies using CT scanning, bony fusion in studies using plain X-rays was 88.3%, and bony fusion in studies using flexion/extension Ten-rays was 91.vii% (Table 4). The cut-off points in angulation changes and differences in interspinous distances on flexion/extension 10-rays vary between articles (Table 5). This did, still, not lead to dissimilar bony fusion percentages for the angulation studies, only did lead to differences in the interspinous distance studies. Remarkably, fusion percentages were college in those studies that allowed 0-mm difference as an upper border for move in contrast to those that allowed upward to 3-mm movement.

Table 4 Overview of different radiological methods of measuring fusion

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Table five Overview of measuring fusion using flexion/extension radiographs

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Measuring bony fusion past judging trabecular bridging on plain Ten-rays resulted in significantly lower bony fusion achievement than using flexion/extension Ten-rays (p < 0.0001). In that location was no statistically significant difference in bony fusion achievement comparison trabeculae on CT scans and flexion/extension X-rays (p = 0.06) or trabecular judgment on CT scans and plain X-rays (p = 0.077). A subgroup analysis was performed with the studies measuring fusion at three-, 6-, 12- and 24-month follow-ups (Fig. 4). Gradual increase in the patients that attained bony fusion over the range of the yr afterward surgery is observed. Again, significantly higher bony fusion accomplishment rates are observed afterward longer periods of follow-upward, though the difference in accomplishment of fusion betwixt 12-calendar month and 24-calendar month follow-ups is again not clinically relevant.

Fig. 4

Fusion rate over fourth dimension, stratified per radiologic technique

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In 38 of the 146 articles, it was mentioned whether the radiographs were analysed by a radiologist or a clinician. In 26 of these, assay was performed by a radiologist [10, 13, 20, 24, 32, 49, 50, 54, 57, 58, 64, 74, 85, 94, 97,98,99,100,101,102,103,104,105,106,107,108]. They institute fusion was accomplished in 93.5% of patients later on a median follow-up of 23 months. In the other 12 articles, the analysis was performed by a clinician, usually a neuro- or orthopaedic surgeon [12, 29, 35, 61, 67, 69, 87, 92, 96, 109,110,111]. They found fusion was accomplished in 85.5% of patients afterward a median follow-up of 23 months. This deviation in fusion accomplishment was statistically significant (p < 0.0001).

Inter-observer variability was only scarcely documented and could therefore not be analysed.

Correlation fusion and type of implant

At FFU, bony fusion was achieved in 91.iv% of patients with os grafts, in 89.1% of patients with PEEK-cages, in 83.four% of patients with PMMA-cages, in 92.9% of patients with carbon fibre cages and in 91.3% of patients with titanium cages (Table half-dozen). As the median fourth dimension to FFU varied greatly, the different bony fusion percentages cannot be compared.

Table 6 Distribution of fusion and patients over different muzzle types

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Correlation bony fusion and use of plates and/or screws

There were 3971 patients who received a plate in add-on to the implant. At FFU, bony fusion was reported in 91.iv% of patients. In that location were 499 patients who received a cage with screws fastened (no plate). At FFU, bony fusion was achieved in 96.6% of these patients. A total of 5738 received a stand-alone implant, without addition of a plate and/or screws. At FFU, the bony fusion rate in these patients was 88.6% (Table 7). In patients treated with a cage with screws attached (no plate), the bony fusion achievement was significantly higher than in patients treated with stand-alone implants and implants with plates (p < 0.0001). In patients treated with stand-alone implants, bony fusion accomplishment was also significantly lower than in patients treated with implants with plates (p < 0.0001). These differences can, yet, not exist concluded to be clinically relevant.

Table vii Distribution of fusion over screw and plate additions

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Using bone growth stimulation

The different types of os growth stimulating agents that were used are autologous os in 3985 patients, allogenic bone in 690 patients, freeze-dried cadaveric allogenic bone in 1188 patients, β-tricalcium phosphate in 474 patients, plasmapore coating in 424 patients, hydroxy-apatite in 311 patients, no filling in 1724 patients and 17 other types of bone growth stimulating agents spread over 1412 patients (Fig. v). The distribution of accomplishment of bony fusion over the dissimilar types of agents is shown in Table 8. As the median time to FFU varied greatly, the unlike bony fusion results cannot be compared.

Fig. five

Distribution of bone growth stimulating agents over patients

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Table 8 Distribution of fusion over bone growth stimulating agents

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Correlation of bony fusion and elevation and surface of implant

Dimensional aspects of the implants were described in 19 studies [19, 27, 42, 45, fifty, 51, 53, 72, 74, 77, 81, 85, 94, 111,112,113,114,115,116]. Only the written report by Yoo et al. [116] assessed these aspects in relation to accomplishment of bony fusion. This report had a depression risk of bias and establish no correlation between a cage height of more 7 mm and the absence of bony fusion (odds ratio 3.852; p = 0.101).

Correlation between bony fusion and clinical outcome

Clinical outcome was assessed in relation to bony fusion in 18 studies (Tabular array 9) [25, 37, 40, 63, 84, 95, 105, 107, 109, 112, 116,117,118,119,120,121,122,123]. Of these, 17 studies had a low risk of bias and i written report had a high risk of bias. Out of these 18 studies, 3 found a statistically significant correlation between the occurrence of bony fusion and a good clinical outcome [109, 120, 122]. The other 15 studies did not find a correlation betwixt bony fusion and clinical outcome. Accomplishment of bony fusion in studies that did find a correlation was significantly lower than in studies that did not find a correlation (69.three% versus 89.8%, p < 0.0001). None of these studies correlated clinical outcome with achievement of bony fusion at different time points.

Table 9 Clinical result was assessed in correlation to fusion in 18 studies

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The study by Klingler et al. [109] retrospectively compared patients treated with PEEK and PMMA implants. Clinical outcome was evaluated using the visual counterpart calibration (VAS), the cervix disability index (NDI), the short-form 36 health survey (SF-36) and the patient satisfaction index (PSI). In patients with a PMMA implant, the fusion accomplishment later on a median FFU of 46 months was 47.ane%. Fused patients showed a statistically significant better physical component summary of the SF-36 than not-fused patients (p = 0.024). As the MCID for this measure is 15 [vii], and the accented difference between fused and non-fused patients is 9.2, this difference was not deemed clinically relevant. There was no correlation between bony fusion and other clinical issue measures. In patients with a PEEK implant, fusion was accomplished in 62.2% of patients after a median FFU of xvi months. There was no correlation with any of the clinical outcome measures.

The study by Schroder et al. [120] prospectively studied patients treated with titanium cages and evaluated clinical consequence using Odom's criteria. At FFU (median twenty months), fusion was accomplished in 74.0% of patients. The occurrence of fusion was correlated with splendid and good results, whereas the absence of fusion was correlated with satisfactory and poor results (p = 0.0364). When using Odom's criteria, an MCID cannot be established; therefore, clinical relevance could not exist assessed.

The report by Wright et al. [122] prospectively studied patients treated with autologous bone grafts and evaluated clinical issue using VAS scores for neck pain and arm pain. At FFU (median 12 months), fusion was accomplished in 82.ix% of patients. The absence of fusion was correlated with higher VAS scores for neck hurting. Such correlation was not institute for VAS arm pain. Accented values were not provided in this article; therefore, clinical relevance could non exist assessed.

Give-and-take

Afterward ACDF surgery, bony fusion is achieved in approximately 90% of patients subsequently a median follow-upwards fourth dimension of 20.5 months. Bony fusion rate studies demonstrate approximately 50% of fusion after 3 months, 75% later on 6 months and ninety% from 12 months on. The differences between 12 and 24 months of follow-up are not clinically relevant in the overall group, or when stratified per radiologic technique. From this, it can be concluded that 12 months of follow-up is sufficient.

Methods to determine achievement of bony fusion seem to influence the judgement of bony fusion. Plain X-rays consistently testify lower bony fusion results, even after a longer period of follow-up, and fusion results are too influenced by choosing cutting-off levels for assessment of bony fusion. Comparable fusion results were institute in comparing trabeculae on CT scans and move on flexion/extension X-rays. As in that location is no generally accustomed definition of bony fusion, the different techniques cannot be compared to a gilded standard and information technology is not possible to decide which method is more accurate.

A pregnant correlation was found betwixt fusion accomplishment and whether the imaging was analysed by a radiologist or a clinician. Since the manufactures used in this analysis did non provide additional information on this topic, and none of the articles compared radiologists and clinicians, no explanation towards this difference can be given.

The lack of a mostly accepted definition of fusion is due to the absence of studies that compare fusion in an intervention group with fusion in command groups. Observing bridging of bone trabeculae on X-ray or CT scans is a qualitative measure. Measuring movement on flexion/extension is quantitative and can serve equally a method to develop a gold standard. Ouchida and colleagues [124] claim that flexion–deflexion is more accurately measured on dynamic CT scans in comparison with dynamic 10-rays, though once again a control grouping is lacking. A solution could be to consider "the definite fusion group" in a group of patients treated with an intervertebral device. The "definite fusion group" may be formed by patients that demonstrated overgrowth of bone along and through the device. If those patients serve every bit controls for the other patients, the variation around the 0 degree or 0-mm motility measure, owing to the measuring method, could be established. This can help in establishing a critical value above which the absence of fusion could exist defined.

Another method was introduced by Johnsson and colleagues [125], who introduced metallic markers in the adjacent bony structures to enable observing movement of the vertebrae. Nevertheless, the accuracy was express to 0.five–0.7 mm and 0.v–ii degrees in this study, which was performed in the lumbar spine. Therefore, it seems inadequate to use a cut-off value of 2 degrees to determine on fusion in the cervical spine, similar some of the articles included in this review accept done.

A minority of studies (northward = 18) examined the correlation between achievement of bony fusion and clinical outcome. Only 3 studies demonstrated a correlation between the absenteeism of fusion and worse clinical result, 15 studies did not observe a statistically significant correlation. Studies that did find a correlation had lower bony fusion rates than studies that did non observe a correlation, which could mean that the studies that did not find a correlation did not have enough ability to statistically appraise a correlation betwixt fusion and clinical upshot. Furthermore, none of these studies correlated clinical issue with accomplishment of fusion at different time points. It would be interesting to examine improvement of clinical effect correlated with accomplishment of bony fusion over time. A recent report did demonstrate a correlation between the absenteeism of fusion and neck pain and considered ii time-points [124]. Patients with fusion at 6 months had less cervix pain than without fusion at half dozen months, and patients with fusion at 12 months had less neck pain than those without fusion at 12 months. However, the number of patients studied was relatively low. Besides, the deviation in cervix pain betwixt months 6 and 12, nor the difference in fusion, nor the correlation between those 2 was studied.

In future studies, it is recommended to evaluate clinical condition in correlation with bony fusion in an before phase of the fusion process, when fusion is not yet accomplished in the majority of patients. Conclusions on the correlation of bony fusion and clinical status cannot exist drawn based on the bachelor literature.

Articles with loftier hazard of bias reported higher percentages of bony fusion achievement than articles with low hazard of bias. In articles with a high chance of bias, the method of measuring bony fusion was frequently not described, therefore, the higher fusion rates tin can be due to improper determining of bony fusion.

When comparing different types of implants, os growth stimulating agents, plates or cages with screws and dimensional aspects of the implant, minor statistically pregnant differences are found in bony fusion accomplishment, which do not reach clinically relevant numbers, in regard to the MCID. Small differences in bony fusion results volition likely non be of importance, if a correlation with clinical outcome cannot be established.

Conclusion

Fusion as a long-term result after ACDF is satisfactory, merely lack of a mostly accustomed definition of bony fusion and differences in study blueprint hamper conclusions on optimising the rate of bony fusion by selection of textile and/or additives. Overall, information technology can be concluded that 12 months of follow-up afterward ACDF is sufficient.

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1. Section of Neurosurgery, Leiden University Medical Eye, Albinusdreef ii, 2300 RC, Leiden, Holland

   I. Noordhoek & C. L. A. Vleggeert-Lankamp

2. Section of Hematology, Leiden University Medical Centre, Leiden, Holland

   M. T. Koning

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Correspondence to I. Noordhoek.

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Noordhoek, I., Koning, M.T. & Vleggeert-Lankamp, C.50.A. Evaluation of bony fusion subsequently anterior cervical discectomy: a systematic literature review. Eur Spine J 28, 386–399 (2019). https://doi.org/10.1007/s00586-018-5820-9

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• Received: 19 May 2018

• Accepted: 04 November 2018

• Published: 17 November 2018

• Effect Engagement: 05 Feb 2019

• DOI : https://doi.org/10.1007/s00586-018-5820-9

Keywords

• Anterior cervical discectomy and fusion
• Radiologic techniques
• Speed of fusion
• Clinical outcome

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