RU2808768C1 - Method of preoperative prediction of development of recurrent disc hernia at the level of the lumbar spine - Google Patents

Abstract

FIELD: medicine; neurosurgery.

SUBSTANCE: invention can be used for preoperative prediction of the development of recurrent disc herniation at the level of the lumbar spine. The presence or absence of modifiable or non-modifiable risk factors is determined, followed by an assessment of the probability of a high or low risk of developing a recurrent disc herniation. Modifiable prognostically significant risk factors include the following indicators: the presence of obesity from grade I to II, difficult working conditions from categories 2 to 3 according to the WHO classification, smoking 1 pack a day for more than 5 years, the presence of diabetes mellitus, low adherence to treatment according to the COP-25 questionnaire less than 50%. Non-modifiable prognostically significant risk factors include the following: intervertebral disc height more than 24.6 mm, or Modic from II to III degrees, age from 40 to 61 years, Grogan from II to III degrees, vascular endothelial factor VEGF value from 3,206.89 pg/ml to 6,146.75 pg/ml, the value of matrix metalloproteinase-8 MMP8 from 11.19 pg/ml to 20.15 pg/ml and the value of beta transforming growth-factor TGFβ1 from 3,674.42 to 5,594.12 pg/ml. The number of modifiable and non-modifiable risk factors is summed up separately. If not more than one non-modifiable factor and 1–3 modifiable factors are identified, as well as if 2–3 non-modifiable factors and 1 modifiable factor are identified, a low risk of relapse after planned microdiscectomy is predicted — less than 30%. When identifying 4–5 non-modifiable factors and 1 modifiable factor, as well as 2–5 non-modifiable factors and 2–3 modifiable factors, as well as 1–5 non-modifiable factors and 4–5 modifiable factors, a high risk of relapse after planned microdiscectomy is predicted — more than 30%.

EFFECT: method provides the possibility of a simple, reliable preoperative prediction of the likelihood of developing a recurrence of a herniated disc at the level of the lumbar spine through an integrated approach — assessment of general clinical, radiation, as well as biochemical and immunological factors reflecting the state of the tissues of the spinal motion segment in real time, available for research in the hospitals with tests examined in the patient’s serum before surgical treatment.

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Description

The invention relates to medicine, in particular to neurosurgery, and is intended for preoperative assessment of the likelihood of recurrent disc herniation at the level of the lumbar spine.

There is a known method for predicting recurrent disc herniations at the level of the lumbar spine - the formula Li, Y. (Li, Y., Wang, B., Li, H., Chang, X., Wu, Y., Hu, Z.,… Li , C. (2021). Adjuvant Surgical Decision-Making System for Lumbar Intervertebral Disc Herniation After Percutaneous Endoscopic Lumber Discectomy: A Retrospective Nonlinear Multiple Logistic Regression Prediction Model Based on a Large Sample. TheSpineJournal. doi:10.1016/j.spinee.2021.07. 012) taking into account the following criteria: height of the intervertebral disc, segmental range of motion, presence of hypertension, presence of diabetes, degree of intervertebral disc degeneration according to Pfirrmann, changes in the end plate according to the Modic type, type of hernia, level of lesion, angle of motion of the lumbar spine, smoking, severe physical labor, presence of postoperative trauma, segmental range of motion in the lumbar spine, severity of physical labor, presence of postoperative trauma. According to the formula provided by the authors:

the risk of recurrent disc herniation is determined at the level of the lumbar spine, where the p value shows the probability of developing a recurrent disc herniation, and for variables x1-x11 the following values are substituted in chronological order: intervertebral disc height, segmental range of motion, presence of hypertension, presence of diabetes, degree degeneration of the intervertebral disc according to Pfirrmann, changes in the end plate according to the Modic type, type of hernia, level of damage, angle of motion of the lumbar spine, smoking, heavy physical labor, presence of postoperative trauma. For binary variables, if the coefficient existed, the value was 1, and if it did not exist, it was 0. A positive angle of lumbar motion was coded 0, a negative angle was coded 1. The scores were directly entered into the appropriate classification (for example, for the Pfirrmann III class, Arabic numeral 3. If a patient experiences post-operative trauma, the likelihood of relapse increases according to the following formula: Where

The accuracy of this forecasting method, according to the authors, is 85.3%.

The disadvantages of this method include the fact that it does not take into account biochemical and immunological parameters that reflect inflammatory processes in the body, the state of connective and cartilage tissue, such as pro-inflammatory cytokines, biomarkers of bone tissue metabolism, and growth factors. It should also be noted that a very important point is that in this method the risk of recurrence of a disc herniation is calculated only after endoscopic neurosurgical treatment, excluding patients operated on with an open technique without endoscopic assistance.

There is also a known method for predicting recurrences of lumbar disc herniations using a trained neural network model - the Parisa model (Azimi, Parisa; Mohammadi, Hassan R.; Benzel, Edward C; Shahzadi, Sohrab; Azhari, Shirzad (2015). Use of Artificial Neural Networks to Predict Recurrent Lumbar Disk Herniation. Journal of Spinal Disorders and Techniques, 28(3), E161-E165. doi:10.1097/BSD.0000000000000200). This method included the following variables: age, gender, duration of symptoms, nicotine addiction, level of disc herniation recurrence, type of intervertebral disc herniation, sports activity, work severity, driving, visual analogue scale (VAS), Zung Depression Scale (ZDS) and the Japanese Orthopedic Association (JOA) scale. The authors estimate the accuracy of this prognostic model at 94.1%, however, a calculation formula or other method for predicting the development of recurrent intervertebral disc herniation is not provided.

There is also a method for assessing the likelihood of developing a recurrence of a lumbar disc herniation using the following parameters: intervertebral disc height index, body mass index, sagittal segmental range of motion, central angle of lumbar lordosis, smoking, type of hernia, type of end plate degeneration according to Pfirrmann.

The closest to the proposed method is a method for predicting recurrence of intervertebral disc herniation at the level of the lumbar spine, proposed by E.S. Baykov. (Baykov, Evgeniy Sergeevich. Forecasting the results of surgical treatment of herniated lumbar intervertebral discs: dissertation... candidate of medical sciences: 01/14/18 / Baikov Evgeniy Sergeevich; [Place of defense: federal state budgetary institution "Novosibirsk Research Institute of Traumatology and Orthopedics named after Ya. L. Tsivyan" of the Ministry of Health of the Russian Federation]. Novosibirsk, 2014. - 135 p.: 39 ill.) In his Ph.D. thesis, E. S. Baikov proposes a method for predicting recurrence of lumbar disc herniation, including studies of the following parameters: intervertebral disc height index, sagittal segmental range of motion, central angle of lordosis of the lumbar spine, changes according to the Modic type, stages of degeneration according to Pfirrmann, retrolisthesis, protrusive type of intervertebral hernia, lumbolization, degeneration of the articular cartilage of the facet joints according to Grogan. The calculations are based on the following formula

Using the available set of initial data, the author estimates the regression coefficients using the likelihood method. To simplify the calculation, the author has created software that allows you to calculate the probability of developing a relapse based on the entered values of the signs, where the last column shows the probability of developing a relapse in percentage equivalent (Fig. 1) - Software for calculating the probability of developing a recurrence of a disc herniation based on the entered values of the signs.

According to the researcher, the resulting model allows predicting the occurrence of relapse with 98% accuracy.

The disadvantages of this method include ignoring biochemical and immunological parameters (pro-inflammatory cytokines, biomarkers of bone tissue metabolism, growth factors) in the forecasting system.

The objective of the invention is a simple, reliable preoperative prediction of the likelihood of developing a recurrence of an intervertebral disc herniation at the level of the lumbar spine.

Unlike the method - the closest analogue, in the developed method the problem is solved due to the fact that it is an integrated approach to predicting relapse by assessing general clinical, radiation, as well as biochemical and immunological factors that reflect the state of the tissues of the spinal motion segment in real time with available for research in hospitals with analyzes examining the patient’s serum before surgical treatment; the method is simple to calculate and interpret and eliminates double interpretation. The invention is based on the results of a study of 124 patients with non-recurrent, single-recurrent and repeatedly recurrent disc herniations of the lumbar spine.

The essence of the present invention is that in each patient with a herniated disc, the presence or absence of modifiable or non-modifiable risk factors is determined, followed by an assessment of the likelihood of a high or low risk of developing a recurrent disc herniation. The following indicators are considered modifiable prognostically significant risk factors: the presence of obesity I-II degree, difficult working conditions according to the WHO classification (category 2-3), smoking for more than 5 years (1 pack per day), the presence of diabetes mellitus, low adherence to treatment according to KOP-25 questionnaire (less than 50%). Non-modifiable prognostically significant risk factors include: height of intervertebral discs more than 24.6 mm, ModicoT Pdo III, age from 40 to 61 years, changes according to the GroganoT II doSh type, value of vascular endothelial factor VEGF in blood serum from 3206.89 pg/ml to 6146.75 pg/ml", the value of matrix metalloproteinase-8 MMP8 in the blood serum from 11.19 pg/ml to 20.15 pg/ml and the value of transforming growth factor-beta TGF β1 in the blood serum from 3674.42 to 5594 .12 pg/ml. The presence of each of the listed assessed indicators is a prognostic criterion associated with a high risk of developing a recurrence of intervertebral disc herniation. Thus, we have developed a table in which, in order to determine the probability of developing a recurrence of an intervertebral disc herniation, it is necessary to substitute the number of modifiable risk factors found in the patient (horizontally) and non-modifiable risk factors (vertically). The risk stratification is based on the scale proposed by Rostovtsev (2002). The cell obtained by placing the factors described above in the table, depending on the color, reflects the probability of the risk of relapse, where the white color of the cell corresponds to a low risk of relapse after a planned microdiscectomy (less than 30%), and the black color corresponds to a high risk (more than 30%). Fig. 2 - Expert advisory table for predicting the risk of developing a recurrence of a herniated disc in the lumbar spine

* Prognostic values of non-modifiable factors used to calculate the risk of relapse: intervertebral disc height more than 24.6 mm, ModicI in the first 6 months after microdiscectomy or Modic from II to III degrees after 6 months, from 40 to 61 years, Grogan from II to III degrees, the degree of facet joint resection is more than 75%, “VEGF from 3206.89 pg/ml to 6146.75 pg/ml”, “MMP8 from 11.19 pg/ml to 20.15 pg/ml” and “TGF 61 from 3674.42 to 5594.12 pg/ml.”

**Prognostic values of modifiable factors used to calculate the risk of relapse: obesity from grade I to II, difficult working conditions (category 2 to 3), smoking for more than 5 years (1 pack per day), diabetes mellitus, low adherence to treatment (less than 50%).

According to the results of a single-factor risk analysis, the probability of predicting these pathologies is 84.7%.

The reliability of predicting the likelihood of relapse using the formula we developed was assessed on the basis of 124 clinical observations of patients with non-recurrent, single-recurrent and repeatedly recurrent intervertebral disc herniations at the level of the lumbar spine with an average follow-up of 3.5 years.

The effectiveness of the proposed method is demonstrated by the following clinical examples:

Example No. 1.

4 modifiable and 3 non-modifiable risk factors

Patient K., 54 years old. She first noticed pain in the lumbar spine about a year ago; her neurological status included radiculopathy along the L5 root on the right, paresis of dorsiflexion of the right foot up to 4 points, and symptoms of tension on the right up to 30 degrees. After performing an MRI of the lumbar spine, a herniated intervertebral disc at the L4-L5 level on the right was diagnosed. The patient underwent microdiscectomy at the L4-L5 level on the right in another clinic. After 6 months, she noted a resumption of the above-described symptoms, an MRI of the lumbar spine was diagnosed with a recurrence of a herniated intervertebral disc at the level of L4-L5 on the right, severe radiculopathic pain syndrome was noted, paresis of dorsiflexion of the right foot up to 4 points, tension symptoms up to 30 degrees, she was admitted for surgical treatment at the State Clinical Hospital named after. S.P. Botkin. A standard laboratory and instrumental study was carried out, general clinical and radiation indicators and indicators determining the levels of VEGF, MMP8, TGF in the blood serum were also examined. In order to predict the likelihood of developing a recurrent intervertebral disc herniation, stratification was performed according to the table we developed for predicting the recurrence of a disc herniation. Modifiable and non-modifiable risk factors were verified: the presence of three non-modifiable (age 54 years, height of intervertebral discs more than 24.6 mm, ModicoT II to III) and four modifiable (presence of obesity I-II degree, difficult working conditions according to the WHO classification (from 2 to 3 categories), smoking for more than 5 years (1 pack per day), the presence of diabetes mellitus) are risk factors, which, when assessing the probability of another relapse according to the proposed table (1), corresponds to a high probable risk of developing a recurrent disc herniation - more than 30%. The patient underwent L5 laminectomy. Medial facetotomy, foramenotomy at the L4-L5 level. Microsurgical discectomy L4-L5. Interbody fusion with PLIF cages, installation of a 4-screw transpedicular fixation system at the L4-L5 level. In the early postoperative period, the patient noted a complete regression of pain and an improvement in general well-being. The patient was activated, verticalized the next day in a lumbar corset, and discharged on the 7th day in satisfactory condition under the supervision of a neurologist at the clinic at her place of residence. There was no recurrence of the intervertebral disc herniation at the L4-L5 level on the right during the follow-up study (3.5 years). The above demonstrates the high specificity of the method for predicting recurrence of disc herniation.

Example 2.

2 modifiable and 0 non-modifiable risk factors:

Patient K., 37 years old.

From the anamnesis it is known that about 3 months ago the patient noted complaints in the form of intense pain in the lumbar spine with irradiation along the posterolateral surface of the right leg, and contacted the advisory clinic of the City Clinical Hospital named after. S.P. Botkin. A neurological examination reveals the presence of symptoms of tension on the right up to a level of 30 degrees, and the presence of radiculopathy syndrome of the right root. Magnetic resonance imaging examination revealed a herniated intervertebral disc at the L5-S1 level with compression of the S1 root on the right. The diagnosis was made: “Osteochondrosis, spondyloarthrosis of the lumbar spine. Intervertebral disc herniation at the L5-S1 level on the right. Radiculopathy of 81 roots on the right.” A standard laboratory and instrumental study was carried out, an assessment of general clinical and radiation parameters was carried out, and indicators determining the levels of VEGF, MMP8, TGF in the blood serum were also studied. In the preoperative period, in order to predict the likelihood of developing a recurrence of an intervertebral disc herniation, stratification was performed according to the table (1) we developed for predicting the recurrence of a disc herniation; for this purpose, modifiable and non-modifiable risk factors were assessed, among which two modifiable risk factors were identified - stage II obesity and the fact of long-term smoking (more than 5 years, more than 1 pack per day), which corresponds to a low risk of developing a recurrent disc herniation - less than 30%. Surgical treatment was performed in the following volume: “L5-S1 interlaminectomy on the right. Microsurgical removal of a disc herniation at the L5-S1 level on the right.” In the early postoperative period, the patient noted a complete regression of pain and an improvement in general well-being. The patient was activated, verticalized the next day in a lumbar corset, and discharged on the 7th day in satisfactory condition under the supervision of a neurologist at the clinic at her place of residence. There was no recurrence of the intervertebral disc herniation at the L5-S1 level on the right. The follow-up period was 2 years.

The above demonstrates the extremely high sensitivity of the method for predicting recurrence of disc herniation.

Example 3.

5 modifiable and 3 non-modifiable risk factors:

Patient P., 40 years old.

From the anamnesis it is known that the patient was first operated on for a herniated intervertebral disc at the level of L4-L5 on the right on 06/01/2017 in another clinic due to pain in the lumbar spine radiating to the right leg along the lateral surface; he also noted paresis of dorsiflexion of the right foot up to 4 points with a diagnosis of “Osteochondrosis, spondyloarthrosis of the lumbar spine. Intervertebral disc herniation at the level of L4-L5 on the left. L5 radiculopathy on the left. Paresis of dorsiflexion of the left foot up to 4 points.” According to the provided medical documentation, surgical intervention was performed in the amount of “Interlaminectomy at the L4-L5 level on the right. Microsurgical removal of a herniated intervertebral disc at the L4-L5 level on the right.” After the first surgical intervention, the patient noted complete regression of pain and neurological deficit. After 12 months, the patient noted a resumption of the above-described complaints in the form of the appearance of intense pain in the lumbar spine with irradiation along the lateral surface of the right leg, and contacted the advisory clinic of the City Clinical Hospital named after. S.P. Botkin, complained of intense pain in the lumbar spine with irradiation along the lateral surface of the right leg. A neurological examination reveals the presence of symptoms of tension on the right up to a level of 30 degrees, and the presence of radiculopathy syndrome of the L5 root on the right. Magnetic resonance imaging examination revealed a recurrence of intervertebral disc herniation at the L4-L5 level with compression of the L5 root on the right. The diagnosis was made: “Osteochondrosis, spondyloarthrosis of the lumbar spine. Recurrence of intervertebral disc herniation at the L4-L5 level on the right. Radiculopathy of the 5th root on the right.” A standard laboratory and instrumental study was carried out, an assessment of general clinical and radiation parameters was carried out, and indicators determining the levels of VEGF, MMP8, TGF in the blood serum were also studied. In the preoperative period, in order to predict the likelihood of developing a recurrent intervertebral disc herniation, stratification was performed according to the table (1) we developed for predicting the recurrence of a disc herniation; for this purpose, modifiable and non-modifiable risk factors were assessed. The presence of three non-modifiable ones is noted (intervertebral disc height more than 24.6 mm, age 59 years, “VEGF from 3206.89 pg/ml to 6146.75 pg/ml”, “MMP8 from 11.19 pg/ml to 20.15 pg /ml" and "TGF 61 from 3674.42 to 5594.12 pg/ml." and five modifiable risk factors (obesity II degree, difficult working conditions (category 3), smoking for more than 5 years (1 pack per day), sugar diabetes, low adherence to treatment (less than 50%), which, when assessed using the proposed method, is characterized by a high risk of relapse (more than 30%). Surgical intervention was performed in the following volume: "Laminectomy L5. Medial facetotomy, foramenotomy at the level of L4-L5 "Microsurgical discectomy of L4-L5. Interbody fusion with PLIF cages, installation of a fixing 4-screw transpedicular system at the level of L4-L5." day in a lumbar corset, discharged on the 7th day in satisfactory condition under the supervision of a neurologist at the clinic at the place of residence. There was no recurrence of the intervertebral disc herniation at the L4-L5 level on the right. Follow-up period was 3.5 years.

Clinical testing of the method has shown that it allows one to objectively and with great accuracy stratify patients with recurrent intervertebral disc herniation at the level of the lumbar spine according to the likelihood of developing a recurrent intervertebral disc herniation, allows timely and adequate selection of the optimal tactics for surgical treatment of these patients, thereby improving the results of their treatment . Thus, the proposed method is simple, accessible, reasonable, reliable and does not require significant time and material costs.

Claims (1)

A method for preoperative prediction of the development of recurrent disc herniation at the level of the lumbar spine, which consists of determining the presence or absence of modifiable or non-modifiable risk factors with subsequent assessment of the probability of a high or low risk of developing recurrent disc herniation, where modifiable prognostically significant risk factors include the following indicators: the presence of obesity from I to II degrees, difficult working conditions from categories 2 to 3 according to the WHO classification, smoking for more than 5 years 1 pack per day, diabetes mellitus, low adherence to treatment according to the KOP-25 questionnaire less than 50%, and to non-modifiable prognostically significant risk factors included: height of intervertebral discs more than 24.6 mm, or Modic from II to III degrees, age from 40 to 61 years, Grogan from II to III degrees, vascular endothelial factor VEGF value from 3206.89 pg/ml to 6146.75 pg /ml, the value of matrix metalloproteinase-8 MMP8 from 11.19 pg/ml to 20.15 pg/ml and the value of transforming growth factor-beta TGF β1 from 3674.42 to 5594.12 pg/ml; summarize separately the number of modifiable and non-modifiable risk factors; and if no more than one non-modifiable factor and 1-3 modifiable factors are identified, as well as if 2-3 non-modifiable factors and 1 modifiable factor are identified, a low risk of relapse after planned microdiscectomy is predicted - less than 30%; and if 4-5 non-modifiable factors and 1 modifiable factor are identified, as well as 2-5 non-modifiable factors and 2-3 modifiable factors, as well as 1-5 non-modifiable factors and 4-5 modifiable factors, a high risk of relapse after a planned microdiscectomy is predicted - more thirty%.

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