Does timely surgery or not affect surgical outcomes in patients with severe spinal tuberculous kyphosis? An observational cohort study

doi:10.21203/rs.3.rs-4875943/v1

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Does timely surgery or not affect surgical outcomes in patients with severe spinal tuberculous kyphosis? An observational cohort study

https://doi.org/10.21203/rs.3.rs-4875943/v1

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Background Spinal tuberculous kyphosis can cause paralysis, severely affecting patient's life. However, timing of the surgery has become a controversial issue. The aim of this study was to explore whether timely surgery would have an impact on surgical outcomes.

Methods In this single-center, retrospective, observational cohort study, we collected clinical data of patients with severe spinal tuberculous kyphosis who underwent surgery from July 1st, 2015 to February 28th, 2019 at Shanghai Changzheng Hospital. We obtained patients' consultation, treatment, and follow-up data from the patient database of Shanghai Changzheng Hospital, and divided them into two groups according to whether they received surgery timely. We compared the data of the two groups using neurological function recovery as the primary outcome indicator and complication rates and deformity correction rates as the secondary outcome indicators.

Results A total of 43 patients were included. 48.8% patients underwent surgery within 2 years and all patients underwent surgery within 7 years after the neurological symptoms onset. We grouped the patients who were treated surgically after 2 years as non-timely surgery group (Group A, Number of cases: 22) and the patients who were treated within 2 years as timely surgery group (Group B, Number of cases: 21). There was no statistically significant difference in correction rates between the two groups. There was a statistical difference in pulmonary complication rates (P = 0.037) and follow-up neurological function recovery rates (P = 0.021).

Conclusion Considering neurological function recovery, deformity correction and complications, we support that patients with severe spinal tuberculous kyphosis should receive surgical treatment as soon as possible after the neurological symptoms onset and preferably within 2 years. This contributes to postoperative neurological recovery in patients as well as reducing the incidence of pulmonary complications.

Spinal tuberculous kyphosis

Surgical treatment

Neurological function recovery

Deformity correction

Complication

Spinal tuberculosis is one of the most common cause of kyphosis in patients¹. Since Mycobacterium tuberculosis can survive for long periods of time in vertebra and disrupt bony structure, the kyphotic deformity may be progressive and unstable². Clinical data suggested that 15% of patients with spinal tuberculosis treated with conservative treatment have a progression of posterior kyphotic angle > 15° and 3–5% may eventually develop > 60° posterior kyphotic angle, followed by paraplegia, which severely affected the patient's quality of life³. Whether to correct the deformity or to protect neurological function, surgical treatment with posterior internal fixation is necessary for patients with severe progressive tuberculous kyphotic deformity^{4, 5}. However, reconstruction of tuberculous kyphosis is a difficult and risky procedure, with a high complication rate and even patient death⁶.

Based on the above studies, some scholars believed that the benefit of surgical treatment for the purpose to correct the deformity was not balanced with the risks⁷. On the other hand, most patients with progressive tuberculous kyphosis will eventually develop neurological symptoms after a prolonged asymptomatic period. At this point, continued conservative treatment will be ineffective⁸. Therefore, some scholars believed that the benefits of timely surgical treatment after the neurological symptoms onset outweighed the risks for these patients^{7, 9}. In this single-center, retrospective, observational cohort study, we propose to analyze the differences in three aspects of neurological function recovery rates, deformity correction rates and complication rates between patients undergoing timely surgery and those not undergoing timely surgery. Aiming to investigate the impact of timely surgery on surgical outcomes.

Patient inclusion and grouping

A single-center, retrospective, observational cohort study of patients who underwent surgical treatment after a definitive diagnosis of spinal tuberculous kyphosis was performed from July 1st, 2015 to February 28, 2019 at Shanghai Changzheng Hospital. Inclusion criteria: (1) the patient was diagnosed with tuberculosis in their adolescence and received standardized anti-tuberculous treatment; and (2) the patient had signs and symptoms consistent with spinal tuberculosis; and (3) the patient had kyphotic deformity and a Cobb angle greater than 80°; and (4) the patient had neurological symptoms and underwent surgical treatment. Exclusion criteria: (1) irregular treatment with anti-tuberculosis drugs; or (2) non-tuberculous spinal cord lesions; or (3) incomplete or missing patient data on clinical information. In conclusion, all patients included in this study were diagnosed with tuberculosis once during their adolescence, developed spinal tuberculous kyphosis, and eventually underwent surgical treatment due to neurological symptoms.

Patients with spinal tuberculosis typically experience a prolonged period of spinal destruction, also known as an asymptomatic period, after which they will develop neurological symptoms. We grouped patients according to the time from the onset of neurological symptoms to surgery. Those who underwent surgery after 2 years were grouped into the non-timely surgery group (group A) whereas those within 2 years were into the timely surgery group (group B).

Clinical data collection and follow-up strategies

In the preoperative and immediate postoperative time, we took the full-length spinal X-rays and collected the Frankle scores of the patients. We used the full-length X-rays to calculate the kyphotic angle and correction rates (preoperative - postoperative / preoperative angle). Within one week after surgery, we need to collect the patients’ lung CT to determine the patient's pulmonary complication rates and neurological physical examination to determine the patient's neurological complication rates.The Frankel score is a simple method for assessing neurological function and consists of five levels. Grade A represents complete sensory-motor loss. Grade B represents partial residual sensation with complete loss of movement. Grade C represents retained sensation with loss of voluntary movement. Grade D represents retained sensation with slight impairment of motor function. Grade E represents basically normal.

About follow-up, there are two points: (1) two years after surgery, we use full-length spinal X-rays to determine the patient's deformity correction rates; (2) three years after surgery, we use Frankle scores to determine the patient's neurological recovery rates. Preoperative, postoperative and follow-up data collection was performed by two different doctors. The doctors were not aware of the specific grouping of the patients. The final result obtained was the average of the measurements taken by the two doctors.

Assessment of surgical outcomes

Since most scholars believed that the purpose of the surgery was to relieve nerve compression and protect neurological function⁹, we took the neurological function recovery rates as the primary outcome. According to patients’ follow-up Frankle score, We categorized patients with Frankle scores D and E as ability of self-care patients and scores A, B and C as inability of self-care patients. The patients who have the ability of self-care were considered to have a good neurological function recovery. On the other hand, this surgery had a high complication rates including pulmonary complications and neurological complications and it was difficult to get a great correction rate since the patient's spine is always very rigid, therefore we selected pulmonary and neurological complication rates and deformity correction rates as secondary outcomes¹⁰. Overall, by comparing the neurological function recovery, complication rates and deformity correction rates between the two groups of patients, we were able to determine which group had a better surgical outcome.

The sample size of this study was calculated based on the primary outcome. According to the pre-test data, we used tests for two proportions as the main statistical method in this study under the requirement of α = 0.05 and 90% certainty, and the required sample size was calculated by PASS software. The results showed that to compare the neurological recovery rates between patients with timely surgery and patients without timely surgery, 21 patients were required in both groups. Therefore, we finally included 43 patients (22 non-timely surgery patients and 21 timely surgery patients).

Statistical Analysis

We used IBM SPSS Statistics for Windows, version 23.0 (IBM Corp., Armonk, N.Y., USA) for statistical analysis. After grouping the patients depending on whether they received surgical treatment within two years after the neurological symptoms onset, we compared the baseline characteristics, deformity correction rates, complication rates, and neurological function recovery rates between the two groups. Data were tested by independent samples t-test. For data that did not meet the criteria of t test, the Wilcoxon rank-sum test was applied. Categorical variables including sex, complication rates and ability/inability of self-care rate was tested by Fisher's exact test. P < 0.05 considered as statistically significant difference.

Baseline characteristics and grouping of patients

According to the inclusion and exclusion criteria, a total of 43 patients were finally included. The inclusion process was detailed in Fig. 1. There were 18 males and 25 females. The most common vertebral region affected was the thoracolumbar spine (T10-L2). The average number of vertebrae involved was 4.34. The average time from their first diagnosis of tuberculosis in their adolescence to neurological symptoms onset was 47.05 years. The average time from neurological symptoms onset to surgery was 3.21 years. After analyzing the clinical course of the patients, we found that no patient had neurological symptoms onset until 38 years after diagnosis, 50% patients had symptoms onset until 46 years, and after 58 years, all patients had symptoms onset. After the onset of neurological symptoms, 48.8% of patients received surgical treatment within 2 years, 88.4% of patients received treatment within 5 years and all patients received treatment within 7 years. Depending on whether the patient received surgical treatment within two years after the neurological symptoms onset, we got the non-timely surgical group (Group A, 22 cases) and the timely surgical group (Group B, 21 cases). We also compared the baseline characteristics between the two groups of patients (Table 1).

Table 1

Comparison of baseline characteristics between two groups of patients
	Group A (> 2 years, N = 22)	Group B (≤ 2 years, N = 21)	P value
Age of diagnosis	11.337 ± 3.568	10.836 ± 3.302	0.636
Height	1.492 ± 0.079	1.459 ± 0.073	0.150
Weight	48.199 ± 5.499	46.340 ± 6.236	0.305
Sex (male/female)	10/12	8/13	0.748
The time from diagnosis to neurological symptoms onset	46.409 ± 4.317	47.952 ± 5.757	0.324

Comparison of baseline characteristics and deformity correction rates

Between group A and group B, There were no statistically significant difference in age of diagnosis (P = 0.636), height (P = 0.150), weight (P = 0.305), sex (P = 0.748) and the time from neurological symptoms onset to surgery (P = 0.324). See Table 1 for details. In comparison of spinal deformity correction between two groups of patients, preoperative kyphotic angle (P = 0.811), postoperative kyphotic angle (P = 0.302) and correction rate (P = 0.269) were no statistically significant difference. See Table 2 and Fig. 2 for details. Overall, there was no significant difference in baseline characteristics and deformity correction rates between the non-timely surgical group and the timely surgical group.

Table 2

Comparison of spinal deformity correction between two groups of patients
	Group A (> 2 years, N = 22)	Group B (≤ 2 years, N = 21)	P value
Preoperative kyphotic angle (°)	91.716 ± 7.893	91.147 ± 7.624	0.811
Postoperative kyphotic angle(°)	30.468 ± 7.277	28.336 ± 6.012	0.302
Correction rate (%)	66.666 ± 7.768	68.985 ± 5.563	0.269

Comparison of complication rates

The pulmonary complication counted in this study was postoperative crural pneumonia while the neurological complication was postoperative sensory or motor dysfunction. In group A, the percentage of pulmonary complication rate was 36.4% while the neurological complication rate was 36.4%. In group B, the percentage of pulmonary complication rate was 9.5% while the neurological complications was 28.6%. There was statistically significant difference in pulmonary complication rate (P = 0.037) but no difference in neurological complication rate (P = 0.586). See Table 3 and Fig. 3 for details.

Table 3

Comparison of complication rates between two groups of patients
	Group A (> 2 years, N = 22)	Group B (≤ 2 years, N = 21)	Total
Pulmonary complication(+)	8	2	10
Pulmonary complication(-)	14	19	33
P value	————	————	0.037
Neurological complication(+)	8	6	14
Neurological complication(-)	14	15	29
P value	————	————	0.586

Comparison of neurological function recovery rates

In group A, the number of patients who have the ability of self-care was 16 preoperatively, 14 postoperatively, and only 8 at follow-up. In group B, the number of patients who have the ability of self-care was 14 preoperatively, 15 postoperatively, and 15 at follow-up. The rate of patients capable of self-care was not statistically different between preoperative (P = 0.665) and postoperative (P = 0.586) in both groups, but was statistically different at follow-up (P = 0.021). See Table 4 and Fig. 4 for details.

Table 4

Comparison of neurological function between two groups of patients
		Group A (> 2 years, N = 22)	Group B (≤ 2 years, N = 21)	Total
Preoperative	Ability of self-care	16	14	30
	Inability of self-care	6	7	13
	P value	————	————	0.665
Postoperative	Ability of self-care	14	15	29
	Inability of self-care	8	6	14
	P value	————	————	0.586
Follow-up	Ability of self-care	8	15	23
	Inability of self-care	14	6	20
	P value	————	————	0.021

Epidemiological data indicate that about 150 million patients die from tuberculosis worldwide, which places a great burden on personal health and socio-economics¹¹. When Mycobacterium tuberculosis infects the spine, due to the depth of the lesion and the lack of obvious symptoms, patients are often unable to discover it in the early stages of the infection. When symptoms appear, Mycobacterium tuberculosis has often already spread through the paravertebral arterial and venous system, which makes it difficult to completely clear the lesion with internal medicine treatment. As a result, the spinal structure is destroyed, and eventually neurological symptoms onset and even paralysis occur^{12, 13}. An epidemiological study showed that the spinal tuberculosis was usually secondary to the tuberculosis lesions in early childhood or adolescence and accounts for approximately 2–4% of patients with tuberculosis¹⁴. According to clinical studies, spinal tuberculosis usually undergoes 4 stages^{15, 16}: (1) implantation stage also called initial stage: within 3 months of primary tuberculosis, Mycobacterium tuberculosis invades the vertebra through bloodstream infection, with no spinal or neurological related clinical symptoms, and slight destruction at the back of the vertebrae can be seen on the imaging¹⁵; (2) early destruction stage: at this stage, Mycobacterium tuberculosis and the immune system reach a state of balance, the paravertebral muscles and the nearby connective tissues form caseous granulomas, and the patient may have low back pain and mild kyphosis of the spine, which lasts for about 9 months¹⁷; (3) late destructive stage: Mycobacterium tuberculosis forms an infected cavity in the vertebra, the intervertebral space narrows, the vertebral body destroyed, the imaging showing worm-eaten-like changes of the vertebral plate, the vertebral body and the intervertebral space blurred¹⁸. At this stage, the patients' kyphotic angle gradually aggravates and finally even reaches more than 60°, but there are no neurological symptoms. This stage generally lasts for more than 30 years; (4) nerve damage or paraplegia stage: this stage usually occurs more than 30 years after the primary tuberculosis, and patients usually have unexplained chronic back pain¹⁹. At the same time, with the aggravation of posterior kyphosis, connective tissue proliferation behind the vertebral body, and long-term accumulation of intervertebral structural disorders, nerve compression or even paraplegia occurs. In our study, we analyzed the clinical course of the patients with severe spinal tuberculosis: 100% of the patients were diagnosed with tuberculosis in their adolescence; they underwent an asymptomatic period of more than 30 years, during which spinal tuberculosis was detected by imaging tests, usually with atypical symptoms such as low back pain, but no patients developed neurological symptoms during this period; after more than 30 years, the patients gradually developed neurological symptoms and underwent surgical treatment within 7 years. This is consistent with the results of previous studies.

Standardized treatment and management of patients with spinal tuberculosis based on the clinical stage can maximize patient benefit¹². Since in the early stages of spinal tuberculosis, the symptoms of the motor system are mild and the spinal kyphotic deformity is also mild, patients often ignore the disease and does not take any therapeutic measures¹⁵. Therefore, pathological testing for tuberculosis and regular anti-tuberculosis treatment are essential during this period. During the destructive stage of spinal tuberculosis, patients often present with posterior kyphotic deformity or unexplained low back pain. Posterior lesion removal alone may improve patient prognosis²⁰. Since there is no nerve damage, spinal internal fixation or neural root canal dilatation is usually not required²¹. In the stage of nerve damage or paraplegia, the patient has a severe spinal kyphotic deformity. Symptoms such as limb weakness and numbness occur due to the compression of the spinal cord as a result of the destruction of the structures in the posterior part of the spine²². Symptoms of nerve compression progress with the severe destruction of bone, at which point at which point surgical treatment is essential. However, in patients with severe spinal kyphotic deformity, spinal kyphosis orthopedic surgery is risky and difficult^{23, 24}. The destruction of vertebral bone around the tuberculosis lesion, loss of the vertebral space, fusion of the vertebral bodies, and peripheral connective tissue proliferation result in a very rigid tuberculosis kyphotic deformity, making it difficult to ensure a good correction rate. At the same time, prolonged tuberculosis causes the patient to be in a state of chronic disease depletion and malnutrition. Severe kyphotic deformity leads to decreased lung function, prolonged hypothermic state due to long orthopedic time and intraoperative blood loss make patients unable to tolerate anesthesia^{10, 25, 26}. Overall, this surgery is a great challenge for the patient as well as the spine surgeon.

Currently, there are no high-quality, large samples, multi-center randomized controlled trials clearly defined the surgical indications for spinal tuberculosis. However, some retrospective studies and even a small number of randomized controlled trials^27–29 have shown that nerve injury is a clear indication for surgery, and it remains controversial whether severe spinal deformity is an indication for surgery⁷. The severity of a patient's spinal deformity is evaluated primarily by whether the patient's kyphotic angle is greater than 80°. If the angle is greater than 80°, the patient always has sagittal imbalance alignments and pulmonary function can be significantly impaired¹⁰. The surgery should be offered to those patients if they are symptomatic (intolerable back pain or neurological function impaired) and are physically fit to undergo surgery⁹. In our study, we grouped our patients depending on whether the surgery was timely or not, and evaluated the surgical outcomes in terms of deformity correction, occurrence of complications, and neurological function recovery. We found that the neurological function recovery of patients in the timely surgical group was significantly better than that of the non-timely surgical group. This is consistent with previous studies^{4, 9, 19}. At the same time, the risks of performing the surgery during the asymptomatic period are not significantly reduced, and the surgery during the asymptomatic period does not provide the patient with benefits beyond correction of the deformity. Therefore, we recommend surgery only after the onset of neurological symptoms, and we believe that the timeliness of surgery is an important factor in the surgical outcomes. Since the symptoms are mild at the time of neurological symptoms onset, usually soreness and numbness of the lower limbs, and obvious sensory-motor disorders often appear a few years later, the patients' willingness to undergo surgery is not strong at the time of neurological symptoms onset, and some of the patients miss the optimal time for surgery. Figure 5 is an example of an untimely surgery while Fig. 6 is an example of a timely surgery. While both patients achieved good correction rates, the neurological function recovery in case 2 was significantly better than that in case 1.

Our study also has some limitations that need to be considered. Firstly, our study is a single-center retrospective study, and a multi-center study with a larger sample size could be considered in the future. Second, because our study is a retrospective study, we used the Frankle score to assess the primary surgical outcome, which was not detailed enough to assess the neurological function of the patients. In the future, if a prospective study is conducted, we would consider using more detailed scores such as the DASH or JOA score to assess the neurological function.

Based on previously reported findings, the following three points were considered: (1) patients with spinal tuberculosis always have more than 30 years from the diagnosis to the neurological symptoms onset; (2) the risk of surgery during the asymptomatic period is not significantly reduced; (3) surgery during the the asymptomatic period does not provide the patient with benefits beyond correction of the deformity. We do not recommend surgery for spinal tuberculosis patients during the asymptomatic period. In addition, our study showed that patients who underwent surgery within 2 years from the neurological symptoms onset retained better neurological function recovery as well as experienced fewer pulmonary complications. Therefore, we suggest that the time from neurological symptoms onset (less than 2 years) be used as a criterion for determining the timing of surgery.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Ethics approval

This study was approved by the Ethics Committee of Medicine, Naval Medical University, PLA.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Author contributions

Yuan Gao and Jianquan Zhao contributed to the data analysis and manuscript writing; Bowen lai and Zhanrong Zhang contributed to the data collection; Xuhui Zhou and Heng Jiang contributed to the design of the study and the final review of the manuscript.

Data availability statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Funding

This study was supported by Voyage Talent Program No. SL07 and People's Liberation Army (PLA) Army Program No.BHJ22J031.

Acknowledgements

We would like to thank all the patients who participated in this stud

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You are reading this latest preprint version

Does timely surgery or not affect surgical outcomes in patients with severe spinal tuberculous kyphosis? An observational cohort study

Status:

Version 1

Abstract

Figures

Introduction

Methods and Materials

Patient inclusion and grouping

Clinical data collection and follow-up strategies

Assessment of surgical outcomes

Statistical Analysis

Results

Baseline characteristics and grouping of patients

Comparison of baseline characteristics and deformity correction rates

Comparison of complication rates

Comparison of neurological function recovery rates

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1