RU2398516C1 - Method of predicting development of endoprosthesis instability after total endoprosthetics in connection with osteoarthritis of hip joint - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to traumatology and orthopedics. In order to predict development of endoprosthesis instability after total endoprosthetics in connection with osteoarthrosis of hip joint, patient's blood serum is tested. Level of primary, secondary and final isopropanol-soluble products of lipid peroxidation (ISPP, ISSP, ISFP) and ascorbate-induced lipid peroxidation (AOA-1, AOA-2) is determined. ISPP, ISSP, ISFP levels are analysed on 10-14 day after operation, as well as 3 and more months after operation. AOA-1 and AOA-2 levels are analyzed only on 10-14 day after operation. Level of primary, secondary and final isopropanol-soluble products of lipid peroxidation and ascorbate-induced lipid peroxidation relative to norm on 10-14 day after operation and 3 and more months after operation is used to predict development of endoprosthesis instability after endoprosthetics of hip joint.

EFFECT: method is simple, available, efficient for long-term prediction of instability development.

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Description

The invention relates to medicine, namely to traumatology and orthopedics, and can be used to assess the stability of implants after hip replacement.

In the world literature, the main emphasis when considering the causes of instability and, accordingly, the development of the basics for predicting this complication are based on the analysis of the quality of endoprostheses, a tribological pair and the implantation technique (Krechko R. “On cementless hip arthroplasty.” Orthopedist. Traumatol. - 1988, No. 10, p. .35-36).

However, analysis of only these factors allows one to reliably conduct only a long-term forecast of the “survival” of the prosthesis, with the exception of gross technological violations.

Known methods for identifying parameters of a laboratory prognosis of the development of instability of the hip joint, based on a comparison of the detailed analysis of blood, C-reactive protein (CRP), serum immunoglobulins, phagocytic activity of fibrinogen, haptoglobin and ceruloplasmin in the pre- and early postoperative period (T.V.Buylova “Biochemical evaluation of the effectiveness of rehabilitation using HBO therapy in patients with pathology of the hip joints.” Medical rehabilitation of patients with diseases and rezhdeniyami musculoskeletal and nervous system: Abstracts - Part 1, M., - 2002).

However, when using these methods, the dynamics of parameter changes in terms of more than 10 days is not traced, which does not allow us to talk about the prognostic significance of the parameters taken in the remote period and indicates the absence of absolute predictive accuracy in the known methods.

A known method for predicting the results of hip replacement, selected as the closest analogue, which involves examining the patient’s blood before surgery and 1-3 months after it, determining the level of high-precision immunoglobulins A and E, the level of eosinophils, the presence of antibodies to metal salts or polymers of endoprostheses and a change in the values of the indicators or at least two of them compared with preoperative ones, an increase in the level of immunoglobulin A more than 3.0 g / l, the level of immunoglobulin E in more than two times, an eosinophil level of more than 7% and the presence of antibodies to metal salts or endoprosthesis polymers predict an unfavorable endoprosthetics result (see patent RU, 2128341, M. class. G01N 33/53, publ. 03/27/1999).

The task, which is solved according to the creators using this well-known technique, is to predict the results of arthroplasty in the early postoperative period.

As shown by the analysis of the above examples, patients in the known method enter into surgery with normal immunological blood counts. Thus, the known method has not been tested to predict the instability of the endoprosthesis in the presence of deviations from the patient already before the operation, including immunological parameters of the blood.

In addition, the known method involves the use of a sufficiently large number of tests, including expensive ones (enzyme-linked immunosorbent assay for IgE today is approximately 1,500 rubles.).

And, finally, as the authors of the known method themselves indicate, it is designed to predict the instability of the endoprosthesis in the early (1-3 months) postoperative period for the timely determination of individual tactics of postoperative treatment aimed at increasing the patient’s immunity and eliminating possible complications, in particular the endoprosthesis conflict joint ”in the postoperative period.

Thus, the known method is a short-term forecasting method and is not effective for a long-term forecast of the development of endoprosthesis instability.

Thus, the technical result, the solution of which the claimed invention is directed, is the creation of an inexpensive, simple and effective method for long-term prediction of the development of instability of the endoprosthesis.

The specified technical result is achieved by the fact that in the known method for predicting the development of instability of the endoprosthesis after total arthroplasty for osteoarthritis of the hip joint, consisting in a study of the patient’s blood serum, according to the invention, the level of primary, secondary and final isopropanol-soluble lipid peroxidation products (IRP) is determined according to the invention , IRVP, IRKP) and ascorbate-induced lipid peroxidation (AOA-1, AOA-2), at this level and IRPI, IRI and IRI, in addition to the study within 3 months or more after the operation, they are additionally examined 10-14 days after the operation, and the levels of AOA-1 and AOA-2 are examined only 10-14 days after the operation, and when primary, secondary and final isopropanol-soluble products of lipid peroxidation and ascorbate-induced lipid peroxidation in relation to the norm on 10-14 days after surgery, respectively:

- IRPP from 201.4% to 222.6%;

- IRWP from 260.3 to 287.7%;

- HDI from 218.5% to 241.5%;

- AOA-1 from 162.45% to 179.55;

- AOA-2 from 267.89% to 296.11%,

and the level of primary, secondary and final isopropanol-soluble lipid peroxidation products in relation to the norm for a period of 3 or more months after surgery, respectively:

- IRPP from 157.7% to 174.3%;

- ИРВП from 112.1% to 123.9%;

- IRKP from 169.1% to 186.9%, they predict a stable position of the endoprosthesis after endoprosthesis replacement, and with an increase in the level of primary, secondary and final isopropanol-soluble products of lipid peroxidation and the level of ascorbate-induced lipid peroxidation with respect to normal 10-14 days after operations respectively:

- IRPP from 353.4% to 390.6%;

- ИРВП from 486.35% to 539.65%;

- HDI from 610.85% to 675.15%;

- AOA-1 from 103.55% to 114.45;

- AOA-2 from 128.72% to 142.28%,

and the level of primary, secondary and final isopropanol-soluble lipid peroxidation products in relation to the norm for a period of 3 or more months after surgery, respectively:

- IRPP from 282.15% to 311.85%;

- ИРВП from 347.7% to 384.3%;

- IRCI from 404.7% to 447.3%, they predict a condition that is threatened by the development of instability of the endoprosthesis after endoprosthesis replacement of the hip joint.

The inventive diagnostic method is simple, because it is based on well-known and accessible biochemical studies.

The inventive method is available to a wide range of patients, so the cost of one analysis as a whole is about 500 rubles, which is much cheaper than one test by the known method.

The inventive method predicts the development of instability of the components of the endoprosthesis in patients who have blood counts that differ from normal ones before the hip joint surgery for osteoarthritis, that is, the claimed method is independent of the patient’s blood counts before surgery.

The inventive forecast method relates to long-term forecasts, with a period of observation of up to 10 years.

Quantitative indicators of blood serum, which determine the prognosis of stability or instability of the endoprosthesis, were determined experimentally by applicants and these findings are confirmed by numerous studies.

The method is as follows.

Before the operation, total arthroplasty for osteoarthritis of the patient is examined according to the generally accepted examination scheme of the patient.

After the operation, total arthroplasty for osteoarthritis of this patient is examined according to the generally accepted scheme for examining the patient after the above operation, including clinical, radiological and biochemical examinations.

Moreover, in the operated patient, the levels of primary, secondary and final isopropanol-soluble lipid peroxidation products (IRPI, IRI, IRI) are examined both 10-14 days after surgery, and within 3 months or more after surgery, and the level of ascorbate-induced lipid peroxidation (AOA-1 and AOA-2) (AOA - antioxidant activity) of blood serum is examined only 10-14 days after surgery.

With an increase in the level of primary, secondary and final isopropanol-soluble products of lipid peroxidation and products of ascorbate-induced lipid peroxidation with respect to the norm for 10-14 days after surgery, respectively:

- IRPP from 201.4% to 222.6%;

- IRWP from 260.3 to 287.7%;

- HDI from 218.5% to 241.5%;

- AOA-1 from 162.45% to 179.55%;

- AOA-2 from 267.89% to 296.11%,

and the level of primary, secondary and final isopropanol-soluble lipid peroxidation products in relation to the norm in terms of 3 or more months after surgery, respectively:

- IRPP from 157.7% to 174.3%;

- ИРВП from 112.1% to 123.9%;

- IRCI from 169.1% to 186.9%, they predict a stable position of the endoprosthesis after endoprosthesis replacement, and with an increase in the level of primary, secondary and final isopropanol-soluble lipid peroxidation products and ascorbate-induced lipid peroxidation products with respect to the norm on 10-14 days after operations respectively:

- IRPP from 353.4% to 390.6%;

- ИРВП from 486.36% to 539.65%;

- HDI from 610.85% to 675.15%;

- AOA-1 from 103.55% to 114.45%;

- AOA-2 from 128.72% to 142.28%,

and the level of primary, secondary and final isopropanol-soluble lipid peroxidation products in relation to the norm in terms of 3 or more months after surgery, respectively:

- IRPP from 282.15% to 311.85%;

- ИРВП from 347.7% to 384.3%;

- IRCI from 404.7% to 447.3%, they predict a condition that is threatened by the development of instability of the endoprosthesis after endoprosthesis replacement of the hip joint.

Quantitative measurement of the level of lipid peroxidation products in heptanisopropanol extracts of biological material was carried out spectrophotometrically according to I. Volchegorsky. with co-authors, which is carried out as follows. To 0.5 ml of the studied biological fluid add 5 ml of a mixture of heptane-isopropanol in a volume ratio of 1: 1, the tube is shaken in a shuttle apparatus for 20 minutes. The extract, free from protein precipitate, was diluted with 5 ml of a mixture of heptane-isopropanol (volume ratio of the mixture 3: 7). 2 ml of hydrochloric acid solution (pH = 2) was added to the diluted lipid extract and complete separation of the extract from the phase was expected within 30 minutes.

The upper (heptane) phase is carefully decanted and transferred to a separate tube. 1 gram of dry NaCl is added to the water-alcohol portion of the lipid extract.

Spectrophotometry of each phase of the lipid extract is carried out at three wavelengths: 220, 232 and 278 nm.

The results are calculated in the form of the so-called oxidation indices - E 232 / E220 and E278 / E220, which reflect the relative levels of primary and secondary products of lipid peroxidation, respectively.

E232 / E220 - the relative content of diene conjugates,

E278 / 220 - level of ketodienes and conjugated trienes.

The determination of the final products of lipid peroxidation by the spectrophotometric method according to E. Lvovskaya et al.: The preparation of lipid extracts, as well as the determination of the primary, secondary products of lipid peroxidation, were carried out according to the previously described method.

The content of the final products of lipid peroxidation was determined by the optical density of the heptane and isopropanol phases of lipid extracts at 400 nm (optical layer thickness 2 cm). The relative content of cipher bases was calculated by the ratio of absorption at 400 nm to optical density at 220 nm (E400 / E220). The latter value is a function of the content of isolated double bonds in extracted lipids, which are substrates of lipid peroxidation.

Determination of the intensity of ascorbate-induced lipid peroxidation according to Lvovskaya E.I. carried out as follows. To the isopropanol extracts of the biological fluid (blood serum), a lipid peroxidation-inducing mixture (0.5 mM ascorbic acid and 50 μM iron sulfate) is added. Then after 10 minutes, when there is the greatest change in the content of molecular products of lipid peroxidation, they are carried out spectrophotometric determination. The oxidation of lipid extracts is evaluated by the ratio of the optical density values E232 / E220, E278 / E220, determined before and after the introduction of the lipid peroxidation-initiating mixture, and expressed as a percentage relative to the initial level.

The dynamics of changes in the level of isopropanol-soluble lipid peroxidation products and ascorbate-induced lipid peroxidation products is not shown in absolute units, but in relative units in relation to the norm. The sample of indicators was made on 100 healthy people, 120 patients with a stable position of the hip prosthesis for periods of 8 to 10 years and 53 patients with the subsequent development of endoprosthesis instability.

The applicant provides a conditional example of calculating the increase in the level of one of the studied indicators - IRPP. The level of IRPI of blood serum in healthy people is 0.415 ± 0.03 cu We choose one of the interval values for the conditional example - 0.385 cu This value is taken as 100%. On the 14th day after the operation of total arthroplasty for deforming osteoarthrosis in a patient, the level of RTI is 0.857 cu This level of IRPI is 222.6% in relation to the norm. After three months, the patient’s IRPI level is 0.671 cu, which is 174.3% with respect to the norm. These data, taking into account the levels of IRVP, IRKP and AOA-1, AOA-2, calculated in the same way, are the basis for a favorable forecast. The level of IRVP in healthy people is 0.317 ± 0.04 cu, IRKV - 0.023 ± 0.001 cu, AOA-1 - 97 ± 4.85 cu, AOA-2 - 91.5 ± 4.85 u .e.

Examples of specific performance.

Example No. 1. Patient E., 59 years old. Diagnosis: Idiopathic osteoarthrosis of the left hip joint of the III st. Combined contracture of the left hip joint. Complaints of pain in the area of the left hip and knee joints, lameness, limitation of movements in the left hip joint. St.Localis: Walks with support on 1 cane, limping on his left leg. Movement in the left hip joint: flexion of 110 °, extension of 150 °, reduction of 75 °, abduction of 80 °, the left lower limb is fixed in the external rotation of 7-8 °. The symptom of Trendelenburg is positive on the left. The relative length of the lower limb is 1 cm. The patient underwent surgery: Total endoprosthetics of the left hip joint with an cementless prosthesis from MATHYS.

The postoperative period was uneventful. 1 day after surgery: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 50 ml of hemorrhagic discharge.

There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, stable.

On the 14th day after surgery: complaints of recurrent pain in the area of surgical intervention. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, there are no signs of instability. The research data on the level of IRPP - 201.4%, IRVP - 260.3%, IRKP - 218.5%, AOA-1 - 162.45%, AOA-2 - 267.89%.

3.5 months after the operation, no complaints, walks without additional support. Movements in the left hip joint: flexion of 90 ° (no longer detected, as this is prohibited by the technology of the operation), extension of 180 °, reduction of 85 ° (no longer detected, since this is prohibited by the technology of the operation), lead 120 °, internal rotation up to 20 °, external rotation was not determined, since this is prohibited by the operation technology. The symptom of Trendelenburg is negative on the left. The length of the legs is equal. On radiographs: condition after hip replacement. There are no signs of instability. The data of the study of the level of IRPP 157.7%, IRVP - 112.1%, IRKP - 169.1%. The prognosis is a stable position of the endoprosthesis after hip replacement for osteoarthrosis.

After 5, 8 and then 10 years: no complaints, gait correct, full movement, radiographs show no signs of instability.

Example No. 2. Patient B. 64 years. Diagnosis: Idiopathic left-sided osteoarthrosis of the III stage. Flexion-causing contracture of the left hip joint. Complaints of pain in the region of the left hip joint, aggravated by exertion and movement, lameness, limitation of movements in the left hip joint. St.Localis: Walks with support on 1 cane, limping on his left leg. Movements in the left hip joint: flexion 125 °, extension 155 °, cast 75 °, lead 90 °, external rotation 10-15 °, internal rotation 0 °. The symptom of Trendelenburg is positive on the left. The relative length of the legs is equal. The operation was performed: Total endoprosthetics of the left hip joint with an cementless prosthesis from MATHYS.

The postoperative period was uneventful. After surgery on day 3: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 50 ml of hemorrhagic discharge. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, stable.

On the 10th day after the operation: complaints of recurrent pain in the area of surgical intervention when walking, getting out of bed. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, there are no signs of instability. The data of the study of the level of IRPP - 222.6%, IRVP - 287.7%, IRKP - 241.5%, AOA-1 - 179.55%, AOA-2 - 296.11%.

3 months after the operation, no complaints, walks relying on 1 cane. Movements in the left hip joint: flexion of 90 ° (no longer determined, as this is prohibited by the technology of the operation), extension of 180 °, reduction of 90 ° (no longer detected, since this is prohibited by the technology of the operation), lead 115 °, internal rotation up to 5-7 °, external rotation was not determined, since this is prohibited by the operation technology. The symptom of Trendelenburg is weakly positive on the left. The length of the legs is equal. On radiographs: condition after hip replacement. There are no signs of instability. The data of the study of the level of ИРПП 174.3%, ИРПП - 123.9%, ИИПП - 186.9%. The prognosis is a stable position of the endoprosthesis after hip replacement for osteoarthrosis.

After 5 years, and then after 8 years: no complaints, gait correct, full movement, radiographs show no signs of instability.

Example No. 3. Patient A. 73 years old. Diagnosis: Idiopathic right-sided osteoarthrosis of the III degree. Combined contracture of the right hip joint. Complaints of pain in the area of the right hip joint with irradiation in the groin, knee joint, lameness, restriction of movements in the right hip joint. St.Localis: Walks with support on 1 cane, limping on his right leg. Movements in the right hip joint: flexion of 95 °, extension of 170 °, reduction of 75 °, abduction of 105 °, the right lower limb is fixed in the external rotation of 5-7 °. The symptom of Trendelenburg is negative. The relative length of the legs is equal. The patient underwent surgery: Total endoprosthetics of the left hip joint with an cementless prosthesis from MATHYS.

The postoperative period was uneventful. There are no clinical or laboratory signs of instability. On the radiograph: the position of the prosthesis is biomechanically correct, stable.

On the 14th day after the operation: complaints of periodic pain in the area of surgical intervention during movement. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, there are no signs of instability. The research data on the level of IRPP - 353.4, IRVP - 539.65%, IRKP - 675.15%, AOA-1 - 114.45%, AOA-2 - 128.72%.

3 months after the operation, no complaints, walks relying on one cane. Movements in the right hip joint: 90 ° flexion (no longer detected, as this is prohibited by the operation technology), 180 ° extension, 85 ° casting (no longer determined, since this is prohibited by the operation technology), 115 ° lead, internal rotation up to 10 °, external rotation was not determined, since this is prohibited by the operation technology. The symptom of Trendelenburg is negative on the right. The length of the legs is equal. On radiographs: condition after hip replacement. There are no signs of instability. The data of the study of the level of HDI - 311.85%, HDI - 384.3%, HDI - 447.3%. Prognosis - a condition threatened by the development of instability of the endoprosthesis after hip replacement due to osteoarthritis.

After 4 years: complaints of pain in the right hip joint during exertion and movements, lameness. St.Localis: Walks without additional support, limping on his right leg. Movements in the right hip joint are painful when performing internal rotation and in the sector of maximum possible movement, internal rotation: flexion of 100 °, extension of 175 °, reduction of 75 °, lead of 95 °, internal rotation of 0 °, external rotation was not determined. The symptom of Trendelenburg is positive on the right. The length of the legs is equal. On radiographs: condition after endoprosthetics of the right hip joint, the acetabular component is rotated in the frontal plane; resorption lines around the femoral component in zones I and VI according to Gruen.

Joint revision, revision endoprosthetics performed. Intraoperatively confirmed instability of the acetabular component.

Example No. 4. Patient U., 74 years old. Diagnosis: Idiopathic right-sided osteoarthrosis of the III degree. Combined contracture of the right hip joint. Complaints of pain in the area of the right hip joint with irradiation in the groin, knee joint, lameness, restriction of movements in the right hip joint. St.Localis: Walks with support on 1 cane, limping on his right leg. Movements in the right hip joint: flexion of 95 °, extension of 170 °, reduction of 75 °, abduction of 105 °, the right lower limb is fixed in the outer rotation of 5-8. The symptom of Trendelenburg is negative. The relative length of the legs is equal. The patient underwent surgery: Total endoprosthetics of the left hip joint with an cementless prosthesis from MATHYS.

The postoperative period was uneventful. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, stable.

On the 10th day after the operation: complaints of periodic pain in the field of surgical intervention during movement. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the radiograph: the position of the prosthesis is biomechanically correct, there are no signs of instability. The research data on the level of IRPP - 390.6, IRVP - 486.36%, IRKP - 610.15%, AOA-1 - 103.55%, AOA-2 - 142.28%.

3.5 months after the operation, no complaints, walks relying on one cane. Movements in the right hip joint: 90 ° flexion (no longer detected, as this is prohibited by the operation technology), 180 ° extension, 85 ° casting (no longer determined, since this is prohibited by the operation technology), 115 ° lead, internal rotation up to 10 °, external rotation was not determined, since this is prohibited by the operation technology. The symptom of Trendelenburg is negative on the right. The length of the legs is equal. On radiographs: condition after hip replacement. There are no signs of instability. The data of the study of the level of IRPP 282.15%, IRVP - 347.7%, IRKP - 404.7%. Prognosis - a condition threatened by the development of instability of the endoprosthesis after hip replacement due to osteoarthritis.

After 4 years: complaints of pain in the right hip joint during exertion and movements, lameness. St.Localis: Walks without additional support, limping on his right leg. Movements in the right hip joint are painful when performing internal rotation and in the sector of maximum possible movement, internal rotation: flexion of 100 °, extension of 175 °, reduction of 75 °, lead of 95 °, internal rotation of 0 °, external rotation was not determined. The symptom of Trendelenburg is positive on the right. The length of the legs is equal. On radiographs: condition after endoprosthetics of the right hip joint, the acetabular component is rotated in the frontal plane; resorption lines around the femoral component in zones I and VI according to Gruen.

A joint revision, revision arthroplasty was performed. Intraoperatively confirmed instability of the acetabular component.

Claims (1)

A method for predicting the development of instability of an endoprosthesis after total endoprosthetics for osteoarthritis of the hip joint, which consists in examining a patient's blood serum, characterized in that when examining a blood serum, the level of primary, secondary, and final isopropanol-soluble lipid peroxidation products (RPI, IRVP, and IRKI) is determined lipid peroxidation (AOA-1, AOA-2), while the levels of IRPI, IRVP and IRKP, in addition to the study in terms of 3 months or more ev after surgery, additionally examined on 10-14 days after surgery, and the levels of AOA-1 and AOA-2, investigated only 10-14 days after surgery, and with increasing levels of primary, secondary and final isopropanol-soluble products of lipid peroxidation and ascorbate-induced lipid peroxidation in relation to the norm on 10-14 days after surgery, respectively: IRPP from 201.4 to 222.6%; IWRP from 260.3 to 287.7%; HDI from 218.5 to 241.5%; AOA-1 from 162.45 to 179.55%; AOA-2 from 267.89 to 296.11%, and the level of primary, secondary and final isopropanol-soluble products of lipid peroxidation in relation to the norm for 3 or more months after surgery, respectively: IRPP from 157.7 to 174.3% ; RTI from 112.1 to 123.9%; An ICRC of 169.1 to 186.9% predicts a stable position of the endoprosthesis after endoprosthesis replacement, and with an increase in the level of primary, secondary and final isopropanol-soluble lipid peroxidation products and the level of ascorbate-induced lipid peroxidation with respect to the norm on 10-14 days after surgery, respectively: IRPP from 353.4 to 390.6%; IWRP from 486.35 to 539.65%; HDI from 610.85 to 675.15%; AOA-1 from 103.55 to 114.45%; AOA-2 from 128.72 to 142.28%, and the level of primary, secondary and final isopropanol-soluble products of lipid peroxidation in relation to the norm for 3 or more months after surgery, respectively: IRPP from 282.15 to 311.85% ; IWRP from 347.7 to 384.3%; An ICRC of 404.7 to 447.3% predicts a condition that is threatened by the development of instability of the endoprosthesis after hip replacement.