RU2397709C1 - Method of prognosis progression of endoprosthesis instability after total endoprosthesis replacement on deforming coxarthrosis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to traumatology and orthopedics. To prognosis progression of endoprosthesis instability after total endoprosthesis replacement on deforming coxarthrosis, seroscopy of the patient is conducted before surgery and 3 months after it. Additional seroscopy of the patient is conducted in 10-14 days after surgery. The level of ferritin and ceruloplasmin is detected. At increase of relative to normal levels of ferritin and ceruloplasmin before surgery, in 10-14 days and after 3 months or more, predict progression of endoprosthesis instability in the bone after hip endoprosthesis replacement.

EFFECT: method is inexpensive, simple, effective and a long-term prognosis of progression of endoprosthesis instability.

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Description

The invention relates to medicine, namely to traumatology and orthopedics, and can be used to assess the effectiveness of 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 is based on the analysis of the quality of endoprostheses, a tribological pair and implantation technique (Krechko R. “On Cementless Hip Endoprosthetics.” 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 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 disorders of the musculoskeletal and nervous systems: 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 arthroplasty, 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, with 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 factor, eosinophil level more than 7% and the presence of antibodies to metal salts or polymers endoprosthesis predict unfavorable result endoprosthesis (see. Patent RU 2128341, Cl. G01N 33/53, publ. 27.03.1999 g).

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 deforming coxarthrosis, which consists in examining the patient's blood serum before surgery and 3 months after it, according to the invention, a blood test is carried out additionally for a period of 10-14 days after operations, in this case, determine the level of ferritin and ceruloplasmin and, with an increase in relation to normal levels of ferritin and ceruloplasmin to operations, respectively, from 233.41% to 257.99% and from 191.04% to 211.16%, on the 10-14th day, respectively, from 262.96% to 290.64% and from 342.66% to 378 , 74% and after 3 months or more, respectively, from 164.47% to 192.31% and from 209.55% to 229.65%, a stable position of the endoprosthesis in the bone is predicted after hip replacement, and with an increase with respect to the norm the level of ferritin and ceruloplasmin before surgery, respectively, from 229.99% to 254.21% and from 162.54% to 179.66%, for a period of 10-14 days, respectively, from 152.07% to 168.13% and from 168, 15% to 185.85%, and for a period of 3 months or more, respectively, from 110.2% to 121.8% and from 1 23.5% to 136.5%, predict a condition threatened by the development of instability of the endoprosthesis after endoprosthesis replacement of the hip joint.

The basis for this conclusion was a clinical, radiological and biochemical study of 1,500 patients with deforming coxarthrosis before and after total arthroplasty for up to 10 years. From this group, a prognosis of instability of arthroplasty was revealed in 53 patients. As a result of the study, it was found that the prognostic criteria for the stability of the endoprosthesis after total arthroplasty for deforming coxarthrosis are an increase in the blood serum content in relation to the norm:

before surgery:

ferritin levels from 233.41% to 257.99%

ceruloplasmin levels from 191.04% to 211.16%

for a period of 10-14 days:

ferritin levels from 262.96% to 290.64%

ceruloplasmin levels from 342.66% to 378.74%

after 3 months or more:

ferritin levels from 164.47% to 192.31%

ceruloplasmin levels from 209.55% to 229.65%,

and prognostic criteria for the instability of the endoprosthesis after total arthroplasty for deforming coxarthrosis are an increase in the content of serum in relation to the norm:

before surgery:

ferritin levels from 229.99% to 254.21%

ceruloplasmin levels from 162.54% to 179.66%

for a period of 10-14 days:

ferritin levels from 152.07% to 168.13%

ceruloplasmin levels from 168.15% to 185.85%

after 3 months or more:

ferritin levels from 110.2% to 121.8%

ceruloplasmin levels from 123.5% to 136.5%.

The inventive diagnostic method is simple, because it is based on well-known biochemical studies available and well-established in medical institutions.

The inventive method is available to a wide range of patients, so the cost of one analysis as a whole is about 200 rubles, which is much cheaper than analyzes by the known method.

The inventive method predicts the development of instability in patients who have before the operation different from normal blood counts.

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

These findings are confirmed by numerous studies.

The proposed method is as follows.

In a patient before surgery for total hip replacement for deforming coxarthrosis, in addition to a general examination, serum ferritin and ceruloplasmin levels are examined.

After the operation, total arthroplasty for deforming coxarthrosis 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.

In this patient, the quantitative content of the level of ferritin and ceruloplasmin is determined in the period before surgery, on the 10-14th day, 3 or more months.

Quantitative measurement of serum ferritin was carried out by the method of solid-phase chemiluminescent immunoassay in the automatic analyzer IMMULITE Futomated Immunoassay Sistem. Alkaline phosphatase was used as a label in the IMMULITE system.

Patient's serum and buffer / serum matrix were simultaneously added to the Test Unit and incubated for about 30 minutes at 37 ° C with occasional shaking. The IMMULITE Test Unit contains a solid phase - polystyrene bead coated with monoclonal antibodies specific for ferritin. In this case, serum ferritin was bound to antibodies on the ball. Unbound materials were then removed by automatic washing, after which alkaline phosphatase-conjugated polyclonal anti-ferritin antibodies were added and the Test Unit was incubated for an additional 30 minutes.

After incubation of the sample with alkaline phosphatase-labeled reagents, the reaction mixture was separated from the pellet by rotation. Unbound materials were removed by automatic washing, after which substrate was added and the Test Unit was incubated for an additional 10 minutes. The chemoluminescent substrate, adamantyl dioxetane phosphate ester, was hydrolyzed to form an unstable compound. The number of bound complexes and, accordingly, the yield of photons measured by a luminometer is proportional to the concentration of ferritin in the sample.

The determination of ceruloplasmin in serum was carried out according to the Ravin method (Bestuzhev S.V. Clinical biochemistry. / S.V. Bestuzhev, V.G. Kolb - Minsk, 1976, pp. 219-220).

Considering that the level of normal serum ferritin and ceruloplasmin depends on the gender, age and region of residence of patients, the dynamics of changes in the level of metalloproteins (ferritin and ceruloplasmin) was carried out not in absolute units, but in relative terms - 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.

When calculating the percentage levels of ferritin and ceruloplasmin, their values are normally taken as 100% each.

With an increase in serum content in relation to the norm:

before surgery:

ferritin levels from 233.41% to 257.99%

ceruloplasmin levels from 191.04% to 211.16%

for a period of 10-14 days:

ferritin levels from 262.96% to 290.64%

ceruloplasmin levels from 342.66% to 378.74%

after 3 months or more:

ferritin levels from 164.47% to 192.31%

ceruloplasmin levels from 209.55% to 229.65%,

predicting a stable position of the endoprosthesis in the bone after hip replacement due to deforming coxarthrosis, and an increase in serum levels relative to normal

before surgery:

ferritin levels from 229.99% to 254.21%

ceruloplasmin levels from 162.54% to 179.66%

for a period of 10-14 days:

ferritin levels from 152.07% to 168.13%

ceruloplasmin levels from 168.15% to 185.85%

after 3 months or more:

ferritin levels from 110.2% to 121.8%

ceruloplasmin levels from 123.5% to 136.5%

predict a condition that is threatened by the development of instability of the endoprosthesis after endoprosthesis replacement of the hip joint due to deforming coxarthrosis.

The applicant provides a conditional example of calculating the increase in the level of one of the studied indicators - ferritan. The level of serum ferritin in healthy people is 20-350 ng / ml. We choose one of the interval values for the conditional example - 87 ng / ml. This value is taken as 100%. Before surgery, the level of ferritin in relation to the norm is 203.07 ng / ml, which is 233.41% in relation to the norm. On the 14th day after the operation of total arthroplasty for deforming coxarthrosis in a patient, the level of ferritin is 228.77 ng / ml. This level of ferritin is 262.96% relative to the norm. After three months, the patient’s ferritin level is 143.09 ng / ml, which is 164.47% relative to the norm. These data, taking into account the levels of ceruloplasmin, calculated in a similar way, are the basis for a favorable prognosis.

The method is illustrated by examples of specific performance.

Example 1. Patient G., 62 years old. Diagnosis: Idiopathic left-sided coxarthrosis of the III degree. The flexion-leading contracture of the left hip joint. Complaints of pain in the left hip joint, lameness, limitation of movements in the left hip joint. St. Localis: Walks resting on 1 cane, limping on his left foot. Movements in the left hip joint: flexion of 80 °, extension of 145 °, reduction of 75 °, abduction of 100 °, internal rotation to 0 °, external rotation of 5 °. The symptom of Trendelenburg is positive on the left. The relative length of the legs is even. Research data on the level of ferritin in relation to the norm before surgery: 233.41%, ceruloplasmin 211.16%.

The patient underwent surgery: total endoprosthetics of the left hip joint with an cementless prosthesis from MATHYS.

On the 2nd day after surgery: complaints of pain in the area of surgical intervention. The dressings are clean, dry, with a drainage 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 periodic 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. Research data on the level of ferritin and ceruloplasmin in relation to the norm on the 14th day after surgery: ferritin - 290.64%, ceruloplasmin - 342.66%.

Three months after the operation, no complaints, walks without additional support. Movements in the left hip joint: flexion of 90 ° (no longer determined, as 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 to 20 °, external rotation was not determined, since this is prohibited by the operation technology. The symptom of Trendelenburg is negative on the left. Leg length is even. Research data on the level of ferritin in relation to the norm, three months after the operation: ferritin - 164.47%, ceruloplasmin - 229.65%. The forecast is favorable.

Five years later: no complaints, gait correct, movement in full, on radiographs there are no signs of instability.

Example 2. Patient S., 66 years old. Diagnosis: Idiopathic right-sided coxarthrosis III art. Flexion-causing contracture of the right hip joint. Complaints of pain in the right hip joint. St. Localis: Walks without additional support, limping on his right foot. Movements in the right hip joint: flexion of 80 °, extension of 165 °, reduction of 65 °, abduction of 105 °, fixed external rotation of 5 °. The symptom of Trendelenburg is positive on the right. The relative length of the right lower limb is 0.5 cm. Research data on the level of ferritin and ceruloplasmin in relation to the norm before surgery, respectively: 254.21% and 179.66%. The patient underwent an operation of total endoprosthetics of the right hip joint with an cementless prosthesis from MATHYS.

On the 2nd day after surgery: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 40 ml of hemorrhagic discharge. There are no clinical or laboratory signs of inflammation.

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 roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability. Research data on the level of ferritin and ceruloplasmin in relation to the norm, respectively: 168.13% and 185.85%.

3.5 months after the operation, no complaints, walks without additional support. 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 detected, as this is prohibited by the operation technology), 120 ° 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: the state after implantation of the hip joint. There are no signs of instability.

Research data on the level of ferritrin and ceruloplasmin in relation to the norm 3.5 months after the operation, respectively: 121.8% and 136.5%.

Forecast: a condition threatened by the development of instability of the hip joint prosthesis.

1.5 years after the operation, the patient complained of pain in the right hip joint during exercise, the return of lameness. S. Localis: Walks without additional support, limping slightly on his right foot. Movements in the right hip joint: flexion of 90 °, extension of 180 °, reduction of 75 °, abduction of 95 °, internal rotation of 5 °, external rotation was not determined, painful sensations when performing internal rotation. The symptom of Trendelenburg is negative. The relative length of the legs is equal. On radiographs: the state after implantation of the hip joint. Relative signs of instability: around the acetabular set of the bone resorption line in zone I no Lee & Chamley (De Lee JSRadiologic demarcation of cemented sockets in total hip replacement. / JSDelee, J.Chamley // Clin. Orthop. - 1976. - Vol. 121 . - P.20-32) line of resorption around the femoral component in zone VII according to Gruen. Research data on ferritin and ceruloplasmin in relation to the norm, respectively: 543.8% and 450.5%. According to the technique developed by the authors, the diagnosis was made: endoprosthesis instability. The patient underwent an operation of revision arthroplasty, which confirmed the diagnosis of instability of the endoprosthesis.

Example No. 3. Patient I., 67 years old. Diagnosis: Idiopathic right-sided coxarthrosis III art. Flexion-causing contracture of the right hip joint. Shortening ave. Of the lower extremity by 1 cm. Complaints of pain in the right hip joint, lameness, limitation 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 120 °, extension of 150 °, reduction of 85 °, abduction of 95 °, internal rotation to 10 ° of external rotation of 20 °. The symptom of Trendelenburg is positive on the right. Relatively shortening of the lower limb, 1 cm. Before the operation, the patient's blood serum ferritin and ceruloplasmin levels were determined in relation to the norm, which were respectively: 229.99% and 162.54%. The operation was performed: total arthroplasty of the right hip joint with a cemented prosthesis from MATHYS.

On the 2nd day after surgery: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 40 ml of hemorrhagic discharge. There are no clinical or laboratory signs of inflammation.

On the 10th day after the operation: complaints of periodic pain in the area of surgical intervention. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability. Research data on the level of ferritin and ceruloplasmin in relation to the norm, respectively: 152.07% and 168.15%.

Control examination of the patient after 3.7 months after surgery: no complaints, walks without additional support. On radiographs: the state after implantation of the hip joint on cement, there are no signs of instability. Research data on the level of ferritin and ceruloplasmin in relation to the norm, respectively: 110.2% and 123.5%.

Forecast: a condition threatened by the development of instability after hip replacement.

Two and a half years after the operation, the patient complained of pain in the right hip joint during exertion and in motion, limp. 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 the maximum possible movement, internal rotation: flexion of 100 °, extension of 175 °, reduction of 75 °, abduction of 95 °, internal rotation was not determined. The symptom of Trendelenburg is positive on the right. The relative length of the legs is equal. On radiographs: condition after hip replacement, absolute signs of instability: the acetabular component is rotated in the sagittal and horizontal planes; resorption lines at the bone-cement border of the femoral component in zone I and VII, double enlightenment lines (bone-cement, cement-endoprosthesis) in the Gruen zone VI. The data on the level of ferritin and ceruloplasmin in relation to the norm are 574.35% and 425.12%, respectively. According to the method developed by the authors for diagnosing the development of instability of the endoprosthesis after total arthroplasty for deforming coxarthrosis, the diagnosis was made: instability of the endoprosthesis.

The revision arthroplasty operation was performed, during which the prognosis of the development of endoprosthesis instability was confirmed.

Example No. 4. Patient P., 68 years old. Diagnosis: Idiopathic right-sided coxarthrosis of the III degree. Flexion-causing contracture of the right hip joint. Complaints of pain in the right hip joint, lameness, limitation of movements in the right hip joint. St. Localis: Walks without additional support, limping on his right foot. Movements in the hip joint: flexion of 80 °, extension of 165 °, reduction of 65 °, abduction of 105 °, fixed external rotation of 5 °. The symptom of Trendelenburg is positive on the right. The relative length of the right lower limb is 0.5 cm. Studies of the level of ferritin and ceruloplasmin in relation to the norm before surgery, respectively: 257.99% and 191.04%.

The patient underwent surgery: total endoprosthetics of the right hip joint with an cementless prosthesis from MATHYS.

On the 2nd day after surgery: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 40 ml of hemorrhagic discharge. There are no clinical or laboratory signs of inflammation.

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 roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability. Research data on the level of ferritin and ceruloplasmin in relation to the norm, respectively: 262.96% and 378.74%.

On the control examination after three months there are no complaints, the level of ferritin and ceruloplasmin are normal at 192.31% and 209.55%, respectively. Radiographs show no signs of instability. Prognosis: a stable position of the implants in the bone after hip replacement.

Control examinations after 3, 5 and 10 years. There are no complaints. On the roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability.

Example 5. Patient S., 65 years old. Diagnosis: Idiopathic left-sided coxarthrosis, III stage Flexion-causing contracture of the left hip joint. Shortening of the left lower limb 1.5 cm. Complaints of pain in the left hip joint, aggravated by physical exertion and movements after a period of rest, lameness, shortening of the left lower limb, restriction of movements in the left hip joint. St.Localis: Walks with one cane, limping heavily on his left foot. Movements in the left hip joint: flexion 115 °, extension 155 °, reduction 60 °, abduction 100 °, internal rotation up to 10 °. The symptom of Trendelenburg is positive on the left. The relative length of the legs of the left lower limb is 1.5 cm. The levels of ferritin and ceruloplasmin are normal, before surgery, respectively: 245.7% and 198.65%. The operation was performed: total endoprosthetics of the left hip joint by the DePuy prosthesis - hybrid fixation: cementless acetabular component, cement - femoral component.

On the 2nd day after surgery: complaints of pain in the area of surgical intervention. Dressings are clean, dry on the drains of 40 ml of hemorrhagic discharge. There are no clinical or laboratory signs of inflammation.

On the 10th day after the operation: complaints of periodic pain in the area of surgical intervention. Primary healing. The seams are removed. There are no clinical or laboratory signs of inflammation. On the roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability. Research data on the level of ferritin and ceruloplasmin in relation to the norm, respectively: 272.68% and 354.74%.

On the control examination after three months there were no complaints, the levels of ferritin and ceruloplasmin were 176.32% and 228.17%, respectively. Radiographs show no signs of instability. Prognosis: stable position of the endoprosthesis in the bone after hip replacement.

Control examinations after 3, 5 and 10 years. There are no complaints. On the roentgenogram, the position of the prosthesis is biomechanically correct, there are no signs of instability.

Claims (1)

A method for predicting the development of instability of the endoprosthesis after total arthroplasty for deforming coxarthrosis, which consists in examining the patient's blood serum before surgery and 3 months after it, characterized in that the blood serum is additionally analyzed for a period of 10-14 days after surgery, while the study determine the level of ferritin and ceruloplasmin and with an increase in relation to normal levels of ferritin and ceruloplasmin before surgery, respectively, from 233.41 to 257.99% and from 191.04 to 211.16%, on days 10-14, respectively, from 262.96 to 290.64% and from 342.66 to 378.74% and after 3 months or more, respectively, from 164.47 to 192.31 % and from 209.55 to 229.65% predict a stable position of the endoprosthesis in the bone after hip joint replacement, and with an increase in the level of ferritin and ceruloplasmin relative to the norm from 229.99 to 254.21% and from 162.54, respectively up to 179.66%, for a period of 10-14 days, respectively, from 152.07 to 168.13% and from 168.15 to 185.85%, and for a period of 3 months or more, respectively, from 110.2 to 121.8% and from 123.5 to 136.5%, they predict a threatened state by EVELOPMENT endoprosthetic instability after total hip replacement.