Retrospective Analysis of the Efficacy and Safety of Endoscopic Spinal Tuberculosis Focus Removal versus Posterior Pedicle Lesion Removal, Bone Grafting, and Internal Fixation Combined with Drug Chemotherapy for Thoracolumbar Tuberculosis

Figures & data

Table 1 Material Characteristics of the Implant

Product name	Interbody fusioN
Manufacturer	TianJin ZhengTian Medical Instrument Co.,Ltd
Specification Model	Posterior Lumbar Interbody Fusion (PLIF)
Model	RP-01
Approval Number	2200085869
Registration Number	20213130654
Structure and composition/main constituents	Interbody cage includes lumbar posterior cage (PLIF), lumbar posterior cage (TLIF), anterior cervical cage, and lumbar lateral anterior cage (OLIF). The fuse device consists of the main body and the developing filament. The main material of the fuse is made of polyether ether ketone (PEEK-OPTIMA LT1) material conforming to YY/T0660 standard, embedded with tantalum developing wire, which is made of R05200 pure tantalum material conforming to ISO 13782 standard. Delivery in a sterilized and non-sterilized form with a sterilization period of 5 years.
Scope of application	Combined with spinal fixation system, it is suitable for interbody fusion in spinal traumatic injury, degenerative lesions and abnormal lesions.

Table 2 Complete Set of Surgical Instruments for Vertebroplasty

Product Name	Disposable RF Plasma Surgical Electrode (Blade)
Model	G21S21
Specification	03
Approval Number	22922053
Registration Number	20172011018
Manufacturing enterprise	Beijing JesHuizhong Technology Co., LTD
Structure and composition/main constituents	The surgical electrode (blade) consists of bipolar plasma blade, knife stem, insulated handle and lead (patient cable)
Scope of application	Use with a radiofrequency plasma surgery host for surgical soft tissue dissection, resection, ablation, hemostasis, and drying

Figure 1 The VAS scoring criteria for low-back pain.

Figure 2 Cobb angle method for waist measurement.

Notes: Apply the method of measuring Cobb angle on the X tablet.

Figure 3 Flow chart of test grouping.

Table 3 Basic Preoperative Data of the Two Groups

Items	A group (n=38)	B group (n=67)	X²/t	P
Age (±s)	74.02±6.31	70.02±17.11	32.731	0.090
Sex(n) Male/Female	17/21	34/33	0.351	0.554
BMI (±s, kg/m^2)	24.48±4.20	23.16±3.50	1.853	0.087
Tuberculosis site(n)			1.411	0.703
Thoracic vertebra	0	2
Thoracolumbar	1	3
lumbar vertebra	31	52
Lumbosacrum	6	10
Cardiovascular and cerebrovascular(n)	18	33	0.035	0.853
Respiratory system(n)	12	27	0.790	0.374
Endocrine system(n)	18	32	0.001	0.969
Metabolic diseases(n)	7	18	0.953	0.329
History of tuberculosis(n)	12	27	0.790	0.374
Erythrocyte sedimentation Rate	49.26±22.77	46.28±20.24	0.058	0.490
C-reactive protein	36.43±42.87	30.99±34.52	4.255	0.479
Procalcitonin	0.28±0.09	0.43±1.20	1.300	0.452
D-Dimer (mg/L)	1.62±0.85	1.35±1.85	2.670	0.394
Neutrophil to Lymphocyte ratio	47.00±21.22	49.41±20.17	0.609	0.565
Hemoglobin (g/L)	122.15±17.02	129.14±20.33	0.238	0.076
Total protein (g/L)	47.44±18.89	42.25±11.87	22.530	0.132
Preoperative lumbar VAS score (score)	7.73±1.36	7.32±1.41	1.162	0.154
Preoperative lumbar ODI score (%)	66.26±8.92	68.56±9.75	0.067	0.233
Preoperative spinal Cobb angle (°)	15.03±0.83	15.04±0.84	0.077	0.989

Notes: The continuous value was given as the mean and the standard deviation. BMI Body mass index=weight/height2.

Abbreviations: VAS, visual analogue scale; ODI, oswestry disability index.

Table 4 Postlumbar VAS and ODI Scores in Both Groups

Items	Follow-up Time	A Group (n=38)	B Group (n=67)	X²/t	P
Low back VAS score (±s, score)	1 month	3.31±1.61	3.38±1.37	2.015	0.808
	3 month	3.00±0.98	2.56±1.22	3.762	0.065
	Last follow-up	1.36±1.10	2.00±0.98	5.124	0.003*
Low back ODI score (±s, %)	1 month	36.57±11.79	35.71±11.68	0.001	0.719
	3 month	26.10±8.76	26.62±9.94	0.803	0.788
	Last follow-up	21.97±6.34	22.80±7.64	2.780	0.571

Notes: The continuous value was given as the mean and the standard deviation. *Bold text represents a statistically significant difference between the two groups.

Abbreviations: VAS, visual analogue scale; ODI, oswestry disability index.

Table 5 Test Tested at 1 Day and Last Follow-Up in the Two Groups

Items	Follow-up Time	A Group (n=38)	B Group (n=67)	X²/t	P
1 day after surgery Inspection index	Erythrocyte sedimentation Rate	49.44±21.46	43.67±23.26	1.138	0.212
	C-reactive protein	84.79±40.40	88.43±80.19	12.428	0.795
	Procalcitonin	0.24±0.06	0.23±0.07	0.311	0.699
	D-Dimer	5.15±3.17	4.10±2.89	0.815	0.100
	Neutrophil to Lymphocyte ratio	52.72±26.45	56.22±29.49	1.385	0.546
	Hemoglobin	112.71±23.90	99.00±16.07	10.839	0.002
	Total protein	56.50±8.50	56.64±5.63	2.570	0.923
The last time after surgery Inspection index	Erythrocyte sedimentation Rate	27.47±14.49	34.65±23.12	19.336	0.087
	C-reactive protein	69.41±53.35	49.99±51.47	0.204	0.070
	Procalcitonin	0.25±0.07	0.24±0.07	0.021	0.518
	D-Dimer	4.70±2.61	4.80±3.03	1.297	0.867
	Neutrophil to Lymphocyte ratio	51.55±22.94	47.88±23.49	0.416	0.440
	Hemoglobin	109.82±20.15	97.07±15.57	6.081	0.001*
	Total protein	62.05±6.97	58.67±8.03	0.565	0.026*

Notes: The continuous value was given as the mean and the standard deviation. *Bold text represents a statistically significant difference between the two groups.

Table 6 Comparison of Postoperative Complications Between the Two Groups

Group	Dural Laceration	Muscular Calf Vein Thrombosis	DVT	Incision Infections	CSF leak	Internal Fixation Loose	Skin Necrosis	Sinus Formation	Postoperative Recurrent Rate
A group (n=38)	0	4	1	2	2	3	3	0	1
B group (n=67)	2	16	4	3	4	4	3	1	10
X²	1.143	2.804	0.596	0.033	0.022	0.144	0.526	0.573	3.908
P	0.258	0.094	0.440	0.856	0.881	0.704	0.468	0.449	0.048*

Notes: *Bold text represents a statistically significant difference between the two groups.

Abbreviations: DVT, deep venous thrombosis; CSF leak, Cerebrospinal fluid leak.

Table 7 Comparison of Transfusion Rates and Transfusion Volume Between Two Groups

Group	Blood Transfusion Rate (%)	Blood Transfusion Quantity (x±s, U)
A group (n=38)	11/28.9	1.02±1.96
B group (n=67)	23/34.3	1.97±2.38
X^2/t	2.007	1.149
P	0.367	0.039*

Table 8 Comparison of Secondary Indicators Between the Two Patient Groups

Items	A Group (n=38)	B Group (n=67)	X²/t	P
Operative time (±s, min)	216.18±45.10	244.44±48.92	0.207	0.004*
Intraoperative bleeding (±s, mL)	214.47±99.77	273.58±149.49	8.950	0.032*
Volume of drainage (±s, mL)	173.94±52.22	189.70±74.66	4.201	0.253
Post-operative downtime/ (±s, d)	3.47±1.57	5.70±2.41	2.996	0.000*
Cobb angle (±s, °)	8.88±2.39	9.81±1.66	8.218	0.038*

Notes: The continuous value was given as the mean and the standard deviation. *Bold text represents a statistically significant difference between the two groups.

Figure 4 Box plots of comparative secondary indicators in the two patient groups.

Notes: (A); Operative time; (B) Intraoperative bleeding; (C) Post-operative downtime; (D); Cobb angle.

Figure 5 Group A is a typical case ①.

Notes: A 57-year-old female patient presented with limited mobility due to back pain for 4 months, worsening over the past month. She was diagnosed with lumbar 3-lumbar 5 spinal tuberculosis. A-B show the patient’s preoperative X-ray, CT, and MRI scans. G-I: CT scans 1 week post-surgery; J-L: MRI scans 1 week post-surgery.

Figure 6 Group A is a typical case ②.

Notes: A 43-year-old male patient was admitted with the primary complaint of “back pain for 1 year, numbness and weakness in both lower limbs for 1 month”. He was diagnosed with thoracic 11-thoracic 12 spinal tuberculosis. A-B show the patient’s preoperative X-ray, CT, and MRI scans. G-I: CT scans 1 week post-surgery; J-L: MRI scans 1 year post-surgery.

Figure 7 Group B is a typical case ①.

Notes: A 34-year-old female patient was admitted with “low back pain and left lower limb pain for 1 year, worsening over the past 2 weeks”. She was diagnosed with thoracic 9-thoracic 12 spinal tuberculosis. A-B: Preoperative lateral X-ray; C-D: Postoperative lateral X-ray; A 66-year-old male patient presented with “low back pain for 6 months”. He was diagnosed with lumbar 1-lumbar 2 spinal tuberculosis. E-F: Preoperative X-ray; G-H: Postoperative X-ray; A 38-year-old female patient was admitted with “back pain for 1 year”. She was diagnosed with thoracic 6-thoracic 9 spinal tuberculosis. I-J: Preoperative anterior lateral X-ray; K-L: Postoperative anterior lateral X-ray; A 73-year-old patient presented with “back pain and right lower limb pain for 6 months”. He was diagnosed with lumbar 4-sacral 1 spinal tuberculosis. M-N: Preoperative X-ray; O-P: Postoperative X-ray.

Figure 8 Group B is a typical case ②.

Notes: A 38-year-old female patient was admitted with the primary complaint of “low back pain and weakness associated with both lower limb pain for 2 months”. She was diagnosed with lumbar 4-lumbar 5 spinal tuberculosis. (A–F) Preoperative X-ray, CT, and MRI; G-L: Postoperative X-ray, CT, and MRI 3 days post-surgery.