RU2457777C2 - Method of controlling rate of distraction in focus of osteogenesis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine and can be used for controlling rate of distraction in focus of osteogenesis. For this purpose rheographic analysis of regional blood flow of affected shin with determination of rhepgraphic index (RI) and maximal rate of rapid blood filling (MRRBF) from the beginning and to the end of distraction is performed. After that thermal diagnostics in osteogenesis focus is carried out by means of thermovision camera and temperature magnitude (TM) is determined. Before the beginning of distraction and 1 time per week temperature magnitude (TM) is determined. Before the beginning of distraction and 1 time per week until its end general index (GI) of bone tissue state in osteogenesis focus is determined by formula: GI+RIxMRRBFxTM. If GI value is lower than 1.0, rate of distraction is reduced to 0.5 mm a day. If GI value is from 1.0 to 2.0 rate of distraction is reduced to 0.75 mm a day. If GI value is higher than 2, distraction is performed at rate 1.0 mm a day.

EFFECT: method makes it possible to increase accuracy of distraction rate determination before operation and control it in the course of treatment due to simultaneous assessment of totality of analysed parameters of affected lower extremity, ensure, as a result, obtaining adequate bone tissue in zone of osteogenesis in earlier term with social rehabilitation of the patient.

6 dwg, 3 tbl, 1 ex

Description

The present invention relates to medicine, namely to traumatology and purulent surgery, and can be used to control the rate of distraction in the treatment of patients with osteomyelitis with shortening and defects of limb bones by distraction osteosynthesis.

A known method for assessing peripheral circulation in the treatment of congenital and acquired shortening of the lower extremities. The study is carried out using the rheographic research system "RISTA-131-REO Reanalyzer" according to the generally accepted methodology before surgery, during periods of distraction and stabilization. In patients during elongation of various segments of the lower extremities by the method of distraction osteosynthesis, rheovasograms were analyzed taking into account the following indicators: rheographic index, dicrotic and diastolic index, time of fast and slow blood supply, pulse wave propagation time, elastic modulus, peripheral resistance index, venous outflow index, etc. . In all the examined patients in the preoperative period, a pronounced asymmetry of blood supply was observed - a decrease in the patient's echnosti an average of 41.8 ± 3.4% relative to intact, most pronounced in children with congenital shortening (54,8 ± 2,6%) and then transferred osteomyelitis (46,9 ± 3,1%). There was an increase in the tone of large and medium arterial vessels, an increase in peripheral resistance, in some patients with post-traumatic shortening, a violation of the venous outflow was detected. After surgery, an even greater asymmetry of the volumetric blood flow was established (average 63.6 ± 4.5%). During the distraction period (by the 4th – 5th week), a gradual normalization of blood circulation parameters was observed: in comparison with the intact limb, the tone of arterial vessels weakened, peripheral resistance decreased, and the pulse wave propagation time increased. During the fixation period, which lasted an average of 2.5 months (from 1.5 to 5 months), the parameters of regional blood circulation normalized, the asymmetry decreased to 32.3%. The state of the peripheral blood circulation of an extended limb, when the blood flow parameters approached those on the intact limb, asymmetry decreased, the tone of large arterial vessels and venous outflow normalized, and this was one of the criteria for the bone regenerate consistency during fixation (1).

There is also a method of controlling the rate of distraction during lengthening of the limb, carried out by determining the integral radio brightness temperature in the regenerate area from the 5th day after the operation. Extension of the limb begins with a rate of distraction of 1 mm per day. The integral radio brightness depth temperature is determined daily in the center of the regenerate of the extended segment and the symmetrical zone of the intact limb with a special sensor for a 4-day cycle. The average value of the integral temperature gradient is calculated, and when its value is lower - 0.3 ° С, the rate of distraction is reduced by 0.5-0.25 mm per day, and after obtaining the average temperature gradient larger - 0.3 ° С, the rate distractions increase by 0.25 mm with an increase to 1.25-1.5 mm per day during the entire period of limb lengthening (2).

Closest to the proposed is the study of peripheral blood flow of the lower extremities in patients with chronic osteomyelitis. The essence of the known method lies in the fact that in the treatment process in patients with defects, overgrown fractures and false joints complicated by chronic osteomyelitis, using the RISTA-131-REO computer analyzer (Taganrog), the state of peripheral blood flow is determined as if it were a patient, and on a healthy lower limb. The asymmetry of blood flow in dynamics is assessed: upon admission to the clinic, 3-4 days after surgery, every 12-15 days of treatment, before and after dismantling of the external fixation apparatus. Almost all patients admitted for treatment showed a decrease in blood flow to the diseased limb, asymmetry before treatment was more than 24.3 ± 13.6% on the thigh and more than 35.2 ± 15.9% on the lower leg. After surgery in the area of the pathological focus and in the area of fixation of the segment by the transosseous apparatus, a sharp deterioration in peripheral blood flow was noted. During treatment, there was a lack of positive dynamics of blood flow before the relief of the inflammatory process in the injured limb. After 1-1.5 months, there was a general tendency to increase blood flow in the affected limb, normalization of the tone of arteries of large, medium and small caliber, venous outflow. However, at the end of treatment, the asymmetry of blood flow remained more than 17.3 ± 9.3% on the thigh and more than 19.3 ± 6.5% on the lower leg. A clear asymmetry was also revealed in the parameters of the excitability of the nerve trunks of the damaged and intact limb (3).

However, the known methods have significant disadvantages, namely:

1. The temperature in the regenerate zone is determined during the entire period of limb lengthening, however, the rate of distraction is changed no earlier than 12 days after the start of distraction (17-20 days after surgery), which can lead to longer periods of treatment, t. to. the rate of distraction affects the speed and quality of the regenerate formed in the distraction zone.

2. The study of peripheral blood flow of the lower extremities in patients allows you to identify blood flow disorders in the diseased limb before surgery and to evaluate its dynamics during treatment. The dynamics of the peripheral blood flow were used to judge the relief of the inflammatory process, or the consistency of the bone regenerate and the end of the fixation period in the external fixation apparatus were determined by the degree of asymmetry of the peripheral blood circulation of the elongated limb. However, the analysis of reographic studies conducted in the preoperative period and during the period of distraction is descriptive, it does not allow to establish a forecast for the regeneration course and to control the rate of distraction during distraction osteosynthesis.

3. The known methods are not objective enough, since they do not conduct a comprehensive examination of the patient in dynamics, namely, they do not simultaneously take into account temperature changes in the regenerate zone and blood flow in the damaged limb, which play an important role in assessing distraction osteogenesis, in which the functional load on the vascular system increases operated organ (4). In conditions of impaired blood flow in chronic osteomyelitis, maintaining the usual rate of distraction (1 mm per day) leads to the formation of a weakly mineralized distraction regenerate and lengthening the duration of treatment (5).

Based on the analysis of the known technologies for controlling the rate of distraction and eliminating the shortcomings of the known technologies, the task was set: to select an optimal and controlled during the treatment process distraction rate for the formation of a full-fledged distraction regenerate, to increase the accuracy of determining the course of bone formation by simultaneously evaluating the set of indicators of the condition of the damaged lower legs in conditions of osteomyelitis.

The problem is solved as follows:

Monitoring the rate of distraction in the bone formation site includes a rheographic study of the regional blood flow of the damaged lower leg with the determination of the rheographic index (RI) and the maximum speed of fast blood supply (MSCI) from the beginning to the end of distraction. New in solving this problem is that they perform remote thermodiagnostics in the center of bone formation using a thermal imager and determine the temperature module (TT). Then calculate once a week until the end of distraction, the total index (OI) of the state of bone tissue in the center of bone formation according to the formula:

OI = RI × MSBKN × TT, where:

OI - the general index of the state of bone tissue in the center of bone formation;

RI - rheographic index, an indicator of the volumetric blood flow of the damaged lower leg;

MSBKN - maximum speed of fast blood supply, the tone of the main arteries;

TT - temperature module, determined using a thermal imager in the center of bone formation. When the value of the general index (OI) is less than 1.0, the rate of distraction is reduced to 0.5 mm per day, when the value of the general index (OI) is from 1.0 to 2.0, the rate of distraction is reduced to 0.75 mm per day, at a total index (OI) of more than 2.0, distraction is performed at a rate of 1.0 mm per day.

We explain the essential distinguishing features of the proposed "Method of controlling the rate of distraction in the center of bone formation."

Performing remote thermal diagnostics in the center of bone formation using a thermal imager and determining the temperature module (TT) in combination with blood flow studies are necessary for an objective, patient-friendly, comprehensive assessment of the activity of the formation of distraction regenerate. Thermal imaging is a remote method for thermodiagnostics of various diseases, based on the principle of capturing infrared (IR) rays emitted by the human body. Thermal imaging provides important information on metabolic and inflammatory processes (6), impaired blood supply to the limbs (7; 8). An increase or decrease in the intensity of infrared radiation in the focus of bone formation (in the area of the supposed osteotomy of the tibia or distraction regenerate) is associated with a change in blood supply and metabolic processes, which depend on the course of regeneration during distraction osteosynthesis and the formation of distraction regenerate.

Calculation with an interval of 1 time per week and until the end of the period of distraction of the general index (OI) of the state of bone tissue in the center of bone formation according to the formula:

OI = RI × MSBKN × TT, where:

OI - the general index of the state of bone tissue in the center of bone formation;

RI - rheographic index, an indicator of the volumetric blood flow of the damaged lower leg;

MSBKN - maximum speed of fast blood supply, the tone of the main arteries;

TT - temperature module, determined with the help of a thermal imager in the center of bone formation, improves the accuracy of determining the course of bone formation on the damaged lower leg. Geographic studies convincingly show that with long bone injuries and, especially, in the conditions of a chronic inflammatory process, regional hemodynamics are disturbed. The state of blood supply to the affected limb is an important factor affecting the course of reparative regeneration when replacing defects in long bones. A rather informative indicator of blood flow in the entire volume of a certain limb segment from all rheovasography parameters is the rheographic index (RI) (9). Arterial blood flow plays a particularly important role in distraction osteosynthesis. Replacement of leg bone defects in patients is accompanied by acceleration of arterial blood flow in the limb, expansion of the great vessels (10). Information on changes in arterial blood flow in the damaged segment of the limb that occurs in response to a fracture, surgical osteosynthesis and distraction, allows you to get the study of the maximum speed of fast blood supply (MSBKN). The temperature module (TT) determined using a thermal imager reflects microcirculatory changes in the site of bone formation (in the emerging distraction regenerate). It is a set of indicators of thermodiagnostics and rheography on the damaged lower leg in conditions of osteomyelitis that allows more precise control of the process of formation of distraction regenerate.

Control over the rate of distraction, when the value of the total index (OI) is less than 1.0, the rate of distraction is reduced to 0.5 mm per day, with the value of the general index (OI) from 1.0 to 2.0, the rate of distraction is reduced to 0.75 mm per day, with a total index (OI) value greater than 2.0, the distraction is performed at a rate of 1.0 mm per day, before the impact on the bone tissue begins, optimal conditions are created for the formation of a complete distraction regenerate during transosseous osteosynthesis of the lower leg under osteomyelitis. Carrying out distraction at a slow pace (0.5-0.75 mm) contributes to the fact that the growth zones of weakly mineralized bone tissue manage to ensure the longitudinal growth of primary osteons along the distraction vector from the proximal and distal bone fragments towards each other (4). The mineralization of the vertices of the primary osteons is not disturbed, full bone tissue is formed.

In the analysis of previously treated patients using the method of distraction osteosynthesis, it was found that the rate of distraction in the bone formation site was determined on the basis of the examination of 47 patients with chronic tibial osteomyelitis with defects of the tibia, in which a study of regional blood flow (RI) and (MSCI) on the damaged lower leg and determined (TT) the temperature in the area of the distraction regenerate with the calculation of the total index (OI) in dynamics. Of these, in 16 people, when a tibia defect was replaced at a rate of 1 mm per day, a dense distraction regenerate was obtained at the optimal time (the optimal treatment time is calculated as follows: 1 day of distraction takes no more than 2-3 days of fixation in the apparatus), the total index value ( OI) was greater than 2.0. In 13 people, the replacement of the tibial defect was performed at a slower pace of 0.75 mm per day due to the formation of low-intensity regenerates according to x-ray data, the general index (OI) was in the range from 1.0 to 2.0. In 18 patients, a distraction rate of 0.5 mm per day was used due to the absence of an x-ray shadow of the regenerate in the area of distraction, while the values of the total index (OI) were less than 1.0.

The essence of the proposed "Method of controlling the rate of distraction in the focus of bone formation" is as follows:

In patients with fractures of the leg tibia, the rheographic index, the maximum rate of rapid blood supply to the damaged tibia and the temperature in the upper third of the tibia are examined at various times: before the start of distraction and once a week until its end. To study the rheographic index (RI) and the maximum speed of fast blood supply (MSBKN), rheovasography of the damaged lower leg is carried out, for example, with the help of the rheography-analyzer RGPA-6112 "Rean-poly" (Taganrog). The patient is laid on the couch in a supine position. Ribbon-shaped electrodes are fixed around the limb in the proximal (upper third of the lower leg) and distal (lower third of the lower leg) part of the test area. The changes in the electrical resistance of blood vessels and surrounding tissues are recorded. Longitudinal rheovasograms are recorded and the rheographic index and the maximum rate of rapid blood supply are analyzed. To measure temperature in the upper third of the tibia, the injured lower leg of the patient is placed in front of the device, for example, with the TKVr-IFP SVIT thermal imager, in a standing position. Thermal imaging research is carried out in real time in a darkened room at a distance of 3 meters from the patient to the device, at a constant room temperature of 23 ° C and stable humidity. The body temperature of the subject in the armpit is measured, the lower half of the body is freed from clothing and the patient is adapted to room temperature for 20 minutes. Then perform panoramic thermal imaging of the legs. Then, the obtained thermograms are processed by placing temperature marks at points corresponding to the zone of the proposed osteotomy of the upper third of the tibia or in the center of the distraction regenerate on the affected lower leg and determine the temperature module (TT). Then determine the total index (OI) of the state of bone tissue in the center of bone formation according to the formula:

OI = RI × MSBKN × TT, where:

OI - the general index of the state of bone tissue in the center of bone formation;

RI - rheographic index, an indicator of the volumetric blood flow of the damaged lower leg;

MSBKN - maximum speed of fast blood supply, the tone of the main arteries;

TT - temperature module, determined using a thermal imager in the center of bone formation.

The data obtained are evaluated, and when the preoperative value of the total index (OI) is less than 1.0, distraction begins at a rate of 0.5 mm per day, with a total index (OI) of 1.0 to 2.0, the rate of distraction is 0.75 mm per day, with a total index (OI) value greater than 2.0, distraction is performed at the usual rate of 1.0 mm per day.

When controlling the rate of distraction in the center of bone formation and maintaining the same indicators of the overall index during treatment of the patient, the rate of distraction does not change. In other cases, the rate of distraction is changed according to the values of the general index. To replace a bone defect, an individual rate is established, controlled throughout the entire period of distraction once a week.

The essence of the proposed "Method of controlling the rate of distraction in the focus of bone formation" is illustrated by the illustrations of the treatment of patient D., where:

Figure 1, a - x-ray of the left lower leg before surgery;

Table 1 - reovasogram of the legs before surgery;

Figure 1, c is a thermogram of the legs before surgery;

Table 2 - rheovasogram of the legs after surgery, at the beginning of distraction;

Figure 2, b is a thermogram of the legs after surgery, at the beginning of distraction;

Table 3 - rheovasogram of the legs in the process of distraction.

Figure 3, b is a thermogram of the legs in the process of distraction;

Figure 4 - x-ray of the left lower leg after the end of distraction;

Figure 5 - x-ray of the left lower leg after dismantling the apparatus.

To clarify the proposed "Method of controlling the rate of distraction in the focus of bone formation" we give a clinical example:

Example No. 1.

Patient D., born in 1986 (I.b. No. 62735), was hospitalized at the clinic of the NRCVH SB RAMS on April 28, 2008. Diagnosis: defect-diastasis of the lower third of the tibia of the left leg. Chronic traumatic osteomyelitis of the lower third of the left tibia.

Injury in August 2002. As a result of an accident, he received an open fracture of the bones of his left leg, was repeatedly operated on, and chronic osteomyelitis developed.

Prior to surgery on April 30, 2008, the patient underwent an X-ray of the left lower leg (see the appendix to the description: Fig. 1, a) and a study was made of the rheographic index (RI) and the maximum speed of fast blood supply (MSCR) of the left lower leg on an RGPA-6112 polyanalyzer rheograph-analyzer “Reanpoli” (Taganrog) and temperature (TT) in the upper third of the tibia of the damaged tibia on the thermal imager TKVr-IFP “SVIT”. Revealed the following data:

- RI of the left lower leg - 0.125 Ohm;

MSBKN of the left shin - 1.42 Ohm / s

(see table 1)

- TT of the upper third of the left tibia - 26.76 °

(see the appendix to the description: figure 1, c)

Calculated by the formula General Index (OI)

OI = RI × ISBKN × TT = 0.125 × 1.42 × 26.76 = 4.7499

When monitoring the rate of distraction before surgery, it was found that the total index (OI)> 2.0, the estimated rate of distraction of 1.0 mm per day.

05/07/2008 with the aim of stopping the osteomyelitis process and replacing the defect of the tibia, the operation was performed: Transosseous osteosynthesis (40) of the lower leg-foot. Segmental resection of the ends of the fragments of the lower third of the left tibia, corticotomy with osteoclasia of the upper third of the left tibia. After surgery, the tibial defect was 50 mm.

05/12/2008, they began lowering the fragment of the proximal fragment of the left tibia in time. The distraction rate of 1.0 mm per day is discrete (0.25 mm 4 times a day).

05/20/2008, a study of the index of the rheographic index (RI), the maximum speed of fast blood supply (MSBC) of the left lower leg on the rheograph-analyzer RGPA-6112 "Reanpoli" (Taganrog) and temperature (TT) in the upper third of the tibia of the damaged lower leg on thermal imager TKVr-IFP "SVIT". Revealed the following data:

- RI of the left leg - 0,083 Ohm;

MSBKN of the left shin - 0.69 Ohm / s

(see table 2)

- TT of the upper third of the left tibia - 32.11 °

(see the appendix to the description: figure 2, b)

Calculated by the formula General Index (OI)

OI = RI × MSBKN × TT = 0.083 × 0.69 × 32.11 = 1.838

When monitoring the rate of distraction after surgery, it was found that the total index (OI) is in the range from 1.0 to 2.0, which corresponds to a rate of distraction of 0.75 mm per day.

We continued to lower the fragment of the proximal fragment of the left tibia in time with a rate of 0.75 mm distraction per day discretely (0.25 mm 3 times a day).

On June 4, 2008, a study was made of the index of the rheographic index (RI), the maximum speed of fast blood supply (MSBC) of the left lower leg on the rheograph-analyzer RGPA-6112 "Reanpoli" (Taganrog) and temperature (TT) in the upper third of the tibia of the damaged lower leg on thermal imager TKVr-IFP "SVIT". Revealed the following data:

- RI of the left tibia - 0.058 Ohm;

MSBKN of the left shin - 0.46 Ohm / s

(see table 3)

- TT of the upper third of the left leg - 30.96 °

(see the appendix to the description: figure 3, b)

Calculated by the formula General Index (OI)

OI = RI × MSBKN × TT = 0.058 × 0.46 × 30.96 = 0.826

When controlling the rate of distraction in the dynamics, it was found that the total index (OI) <1.0, therefore, the rate of distraction is 0.5 mm per day.

We reduced the rate of distraction to 0.5 mm per day discretely (0.25 mm 2 times a day) and continued the replacement of the tibial defect. For the entire remaining period of distraction, the values of the total index (OI) remained less than 1.0, so the rate of distraction no longer changed.

08/16/2008 completed the replacement of a tibial defect. The period of distraction was 85 days, grown distraction regenerate 50 mm (see. Appendix to the description: figure 4). Further clinical and radiological examination of the regenerate confirmed the favorable course of regeneration and the formation of a dense distraction regenerate. The fixation period in the AVF was 127 days, the AVF was dismantled (see the appendix to the description: figure 5).

Thus, the proposed "Method of controlling the rate of distraction in the site of bone formation" in comparison with known technologies allows to increase the accuracy of determining the rate of distraction before surgery and to monitor during treatment by simultaneously evaluating the totality of the studied parameters of the damaged lower limb in conditions of osteomyelitis. The rate of distraction is set more objectively and strictly individually at any stage of treatment, changes in a timely manner, which ensures that a full-fledged bone tissue is obtained in the bone formation zone at an earlier date, socially rehabilitating the patient.

Table 1 PARAMETER Units rev. Wed (a lion.) SKO (Lev.) Wed (etc.) DIS (ave.) Normal zone RI Ohm 0.125 0.008 0.123 0.011 0.060-0.110 PPSS % 60 2 58 fifteen 34-43 IASB Ohm / s 1.42 0.13 1.57 0.18 0.74-1.11 DSI % 59 7 60 eleven 34-43

table 2 Parameter Units rev. Wed (a lion.) SKO (Lev.) Wed (etc.) DIS (ave.) Normal zone RI Ohm 0.083 0.007 0.116 0.008 0.060-0.110 PPSS % 77 fourteen 74 fifteen 34-43 IASB Ohm / s 0.69 0.08 1.46 0.13 0.74-1.11 DSI % 43 25 41 23 34-43

Table 3 Parameter Units rev. Wed (a lion.) SKO (Lev.) Wed (etc.) DIS (ave.) Normal zone RI Ohm 0.058 0.002 0.245 0.014 0.060-0.110 PPSS % 73 13 44 12 34-43 IASB Ohm / s 0.46 0.05 3.27 0.25 0.74-1.11 DSI % 34 8 34 3 34-43

Information sources

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Claims (1)

A method for controlling the rate of distraction in the site of bone formation, including a rheographic study of the regional blood flow of the damaged lower leg with the determination of the rheographic index (RI) and the maximum speed of fast blood supply (MSCI) from the beginning to the end of distraction, characterized in that they perform remote thermal diagnostics in the area of bone formation using a thermal imager and determine the temperature module (TT), then before the start of distraction and once a week until its end determine the total index (OI) of the state of bone tissue in the center of bone formation according to the formula:
OI = RI × MSBKN × TT,
where OI is the general index of the state of bone tissue in the center of bone formation;
RI - rheographic index, an indicator of the volumetric blood flow of the damaged lower leg;
MSBKN - maximum speed of fast blood supply, the tone of the main arteries;
TT - temperature module, determined using a thermal imager in the center of bone formation; and
when the value of the general index (OI) is less than 1.0, the rate of distraction is reduced to 0.5 mm per day, when the value of the general index (OI) is from 1.0 to 2.0, the rate of distraction is reduced to 0.75 mm per day, with the value a total index (OI) of more than 2.0 is performed at a rate of 1.0 mm per day.

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