RU2747589C1 - Method for treating meniscus injury of knee joint - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to traumatology and orthopaedics, and can be used for treating a medial meniscus injury without reaching an articular surface bordering on the joint cavity. Method involves a preliminary examination with MRI of the injured region of the joint, determination of a degenerative meniscus adjustment zone and introduction of a therapeutic composition stimulating the restoration of the damaged tissue in the area of injury. Therapeutic composition used is a platelet-derived mixture obtained from intrinsic blood, which, under ultrasonic control, is delivered into the degenerative meniscus adjustment zone by transcutaneous insertion of the needle into the meniscus thickness produced from the popliteal fossa. Therapeutic composition is administered until filling the whole volume of the damaged meniscus tissue. Therapeutic composition can also be introduced directly through the posterior surface of the joint into the meniscus and into the border zone of the capsule at a point closest to the posterior horn of the medial meniscus. Thrombocyte mixture can be administered in amount of 0.5 ml. When the needle is removed, 0.5 ml of a platelet mixture is added to the border zone of the joint capsule, and the platelet preparation is introduced with a puncture needle. Filling of the affected area with a drug is carried out from the centre of the area to its periphery.

EFFECT: method provides efficiency and safety ensured by manipulations only in the area of joint damage and using patient's own blood.

6 cl, 3 ex

Description

The invention relates to medicine, in particular to traumatology and orthopedics, and can be used in the treatment of menisci with injuries without reaching the articular surfaces (first and second degree injuries according to the Stoller classification - (David W. StolIer, MD Magnetic Resonance Imaging in Orthopedics and Sports Medicine 1993 (139-230).

A known method of repairing meniscus tears, including the use of arthroscopically installed staples or suturing the edges of the gap using collagen (US patent No. 60/713360, from September 2, 2005).

The method is ineffective, has a high enough trauma and cannot be used to treat meniscus injuries of the first and second degree.

A known method of stimulating reparative chondrogenesis (restoration of the integumentary cartilage) with intra-articular osteochondral lesions, providing for the introduction into the joint cavity of a fibrin clot obtained from autologous blood (RU 98 114 560 A61R 19/02, 1998)

The disadvantage of this method is its laboriousness, the impossibility of fixing and fixing the position of the fibrin clot in the affected area and the associated inefficiency of the method, which, in general, makes it impossible to use it for the treatment of meniscus injuries of the first and second degree.

An object of the present invention is to provide an effective method for treating first and second degree meniscus lesions, i. E. with injuries that do not extend to the surface adjacent to the joint cavity, exclusion of bringing the injury to a complete rupture of the meniscus and loss of joint mobility with the progression of osteoarthritis, reducing the frequency of surgical interventions aimed at treating meniscus injuries, reducing the cost of surgical actions and carrying them out on an outpatient basis , reducing the period of the patient's disability.

This goal, in the proposed method, is achieved due to the fact that after determining with the help of ultrasound the exact location of the affected area of the meniscus, under the same ultrasound control from the popliteal fossa, a percutaneous needle is drawn into the thickness of the meniscus, precisely in this specific zone, and after connecting to the syringe needle with a platelet mixture obtained from the patient's own blood in an amount of 1.0 ml., Deliver it directly to the affected area of the meniscus, while the position of the needle is manipulated to fill the entire area of the meniscus injury with the platelet mixture, that is, it is delivered and filled with it the entire volume of the affected meniscus zone, where it is guaranteed to be fixed, fixing against movement by the boundaries of the damage zone, since the damage is located in the thickness of the meniscus. Thus, the action of the mixture is carried out directly on the affected area, thereby exciting and activating recovery processes in this area. At the same time, the outflow of the mixture from the zone of damage is also excluded, on the one hand, by the border of the meniscus and the body of the bone, and on the other hand, by the intact surface of the meniscus' own body, since damage to the meniscus of the first and second degree is characterized by the absence of through damage to the meniscus, when the meniscus is damaged into the zones having direct contact with the articular surfaces of the femur and tibia - a rupture of the body of the meniscus.

The platelet mixture used in the method is produced by centrifuging the patient's own venous blood, which makes this method highly safe for the patient. The method of obtaining a platelet mixture is widely used in medicine and is described in the literature (RU 2618928 A61P 19/00, 2017). The resulting preparation is a concentrate with a high platelet content. The number of platelets in 1 microliter of the mixture reaches 1,200,000 - 2,000,000. Platelets play a key role in the anabolic effect of the platelet mixture, due to the release of growth factors stored in their alpha granules, which stimulates the active growth of cells in the damaged area, increases DNA synthesis in cells of the meniscus.

The presence of these factors of the injected mixture has an active effect on the damaged meniscus: the anti-inflammatory effect is enhanced, the effect of anesthesia is increased, the connective tissue is actively formed in the damaged area, thus contributing to its healing.

The method is carried out as follows.

Before treatment, the patient undergoes preliminary preparation and assessment of the condition to obtain the best result:

- Discontinuation of anticoagulants is required in 2 weeks;

- It is required to refrain from taking non-steroidal anti-inflammatory drugs for two weeks before and after the procedure, since drugs in this group can block growth factors;

- Drink plenty of fluids the day before the procedure;

- Stress, tobacco and alcohol should be avoided;

- The content of platelets in the general blood test is assessed and the presence of platelets below normal is not allowed.

Initially, the patient draws venous blood into a 20 ml syringe. First, take into a syringe 1.5 ml of anticoagulant (ACD-A (citrate hemo-preservative solution with dextrose) to prevent blood clotting and 15 ml of blood. The contents are stirred in a wave-like motion in the syringe. From the syringe, blood is poured into a special container, which is then installed in centrifuge (low-speed, floor-standing) with an angle rotor. The frequency of rotation is set at 3500 rpm. The time of the first centrifugation is 4 minutes, the second - 2 minutes. After centrifugation, a three-layer liquid is formed in the container: the upper layer is plasma, the intermediate layer is whitish, This is a layer of platelet suspension, the lower layer is a layer of formed elements of blood-erythrocytes.In the syringe, we collect the central layer with rotary movements from a test tube - a layer of platelet suspension, up to 1 ml.

Then the patient lies on the couch, on his stomach. The leg is in the position of full extension, covered with sterile sheets, leaving the area for the manipulation - the popliteal fossa region. The site is being treated with an antiseptic solution. The ultrasound probe is covered with a protective material (sterile glove) and with its help the zone of degenerative restructuring of the meniscus is determined - the zone of its damage. Then, under the control of ultrasound, a 23G needle is used to conduct it percutaneously into the thickness of the meniscus precisely into this zone identified by ultrasound. Next, a syringe with a platelet suspension is connected to the needle. About 0.5 ml of platelet suspension is injected directly into the meniscus. By manipulating the needle under ultrasound control, a suspension is also injected into the peripheral areas of the lesion, filling it with the entire volume of the damaged meniscus tissue. The introduction is made from the place of attachment of the meniscus to the capsule towards the central part of the meniscus. After filling the meniscus injury zone with a platelet suspension, the needle is removed and about 0.5 ml of platelet mass is injected into the border zone of the joint capsule - the latter action further enhances DNA synthesis and the supply of "building material" to the meniscus affected zone for its regeneration.

The needle is removed from the soft tissue. An aseptic dressing is made. Immobilization of the joint with this method of treatment is not required. The patient is given recommendations to limit physical activity for 2-3 days (excluding any power loads, running, deep squats, etc.). The patient leaves the outpatient clinic on his own, without additional support. Examination and the next procedure in 6-8 days. The number of procedures is two to three until the damaged area of the meniscus is completely restored.

Example # 1.

Patient M., 30 years old (height 180, weight 81, body mass index -25) was admitted to the Department of Traumatology and Orthopedics with complaints of recurrent pain in the knee joint arising during exercise, rarely at rest. The pain first appeared about 3 months ago after playing sports. He was treated conservatively at the place of residence (with the help of non-steroidal anti-inflammatory drugs and FTL), without a persistent positive effect. Physical activity provokes pain. In his youth he was engaged in martial arts. Candidate to master sport. Upon admission: he moved independently, without additional support. Visually, the axis of both lower limbs is normal. Full movement in the right knee joint, painful maximum flexion. Baikov's, McMuray's, Apley's tests are weakly positive from the inner side of the joint. Hypotrophy of the muscles of the right thigh - 1 cm compared to the opposite side. No effusion. As a result of MRI examination of the right knee joint, a grade 2 medial meniscus injury was diagnosed (according to Stoller). During the follow-up examination, differential diagnosis was carried out, excluding joint lesions of an infectious and non-infectious etiology, as well as pathology from the nervous system (herniated discs, radicular syndrome, etc.), which could give a similar picture. The patient was prescribed percutaneous intrameniscal administration of an enriched platelet suspension under ultrasound control. The introduction was made directly through the posterior surface of the joint at the point closest to the posterior horn of the medial meniscus. In the thickness of the posterior horn of the medial meniscus, 0.5 ml of platelet suspension was injected, in the periphery of the meniscus, about 0.5 ml. the introduction is made from the center to the periphery by gradually pulling the needle towards you.

The patient was advised to limit physical activity. After the administration of the drug, the patient noted soreness for 2 days, the pain went away on its own, the patient described the pain as "aching, similar to a toothache." With an interval of 7 and 14 days, repeated injections were made under ultrasound control. A total of 3 injections were made.

Control MRI 6 months after treatment showed an increase in tissue density in the area of meniscus injury, which indicates replacement of the damaged tissue with new connective tissue. The patient also noted an improvement in the condition of the knee joint (the assessment was made on the Lisholm, Lekken, VAS, and WOMAC scales. Positive dynamics was noted on all scales. After 18 months, there were no signs of negative dynamics on the control MRI.

Example No. 2

Patient - M., 25 years old (height 178, weight 71, body mass index - 22.4) came to the Department of Traumatology and Orthopedics with complaints of pain in the right knee joint arising during exercise, after a long walk, during deep squats ... From the anamnesis, he reported that pain bothers about 6 months. He goes in for football, plays mainly on hard surfaces. For the first time, the pain appeared after training, as if the mechanism and the fact of injury does not remember. The next day, he noted swelling of the joint, increased pain when walking. He turned to trauma for help. a point at the place of residence, where, with a diagnosis of damage to the capsular-ligamentous apparatus of the right knee joint, he received physiotherapy. Noted a decrease in pain. The swelling is gone. But 3 months after returning to the playing field, he began to notice pain in the knee joint after jogging.

Upon admission, he walks independently, without additional support. Visually, the axis of both lower limbs is normal. Full movement in the right knee joint, painful maximum flexion, as well as outward rotation of the lower leg. Baikov's, McMuray's, Apley's tests are weakly positive. Hypotrophy of the muscles of the right thigh - 1 cm compared to the opposite side. No effusion.

During the examination, differential diagnosis was carried out, excluding infectious, non-infectious arthritis, as well as pathology from the nervous system (disc herniation, radicular syndrome), which could give a similar picture. MRI scans showed damage to the posterior horn of the medial meniscus of the right knee joint of grade 2 (according to Stoller), chondromalacia of the medial condyle of grade 1. The patient was prescribed percutaneous intrameniscal administration of an enriched platelet suspension under ultrasound control. The introduction was carried out directly through the posterior surface of the joint at the point closest to the posterior horn of the medial meniscus, into the thickness of the meniscus and in the region of the capsule (the place of attachment of the meniscus root). In the thickness of the posterior horn of the medial meniscus, 0.5 ml of platelet suspension was injected, in the periphery of the meniscus, about 0.5 ml. The introduction is made from the center to the periphery by gradually pulling the needle towards you. Recommendations for limiting physical activity are given. After administration of the drug, the patient noted soreness during the first day. The pain was shooting. With an interval of 7, 14 days, repeated injections were made under ultrasound control. A total of 3 injections were made.

Control MRI 6 months after treatment showed an increase in tissue density in the area of meniscus injury, which indicates replacement of the damaged tissue with new connective tissue. The patient also noted an improvement in the condition of the knee joint (the assessment was made according to the Lisholm, Lekken, VAS, and WOMAC scales. Positive dynamics was noted on all scales. After 18 months, there were no signs of negative dynamics on the control MRI.

Example 3

Patient - J., 42 years old, (height 170, weight 57 kg body mass index - 19.7), turned to the Department of Traumatology and Orthopedics with complaints of pain in the right knee joint arising during physical exertion or after a long vertical position on the legs , also during deep squats (while tying shoelaces). From the anamnesis, he reports that the pain bothers about 4 months, he denies the fact of injury. He works as a hairdresser, spends a long time "on his feet", most often pain occurs by the end of the working day, but also occurs after forced flexion in the knee joint (squatting). Puffiness appears periodically (rarely). She asked for help from a surgeon at the place of residence, with a diagnosis of gonatrosis she received intra-articular injections of hyaluronic acid preparations. Shows insignificant positive dynamics. Upon admission, he walks independently, without additional support. Visually, the axis of both lower limbs is normal. Full movement in the right knee joint, painful maximum flexion. Baikov, McMuray, Apley test - negative. There is no hypotrophy of the muscles of the thigh, compared to the opposite side. No effusion.

During the examination, differential diagnostics was carried out, excluding arthritis of various etiologies, as well as pathology from the nervous system (disc herniation, radicular syndrome), which could give a similar picture. In the clinical analysis of blood without platelet pathology. MRI scans revealed damage to the posterior horn of the medial meniscus of the right knee joint of grade 2 (according to Stoller), chondromalacia of the medial condyle of grade 2. The patient was prescribed percutaneous intrameniscal administration of an enriched platelet suspension under ultrasound control. The introduction is carried out directly through the posterior surface of the joint at the point closest to the posterior horn of the medial meniscus, into the thickness of the meniscus and in the region of the capsule (the place of attachment of the root of the meniscus). In the thickness of the posterior horn of the medial meniscus, 0.5 ml of platelet suspension was injected, in the periphery of the meniscus, about 0.5 ml. The introduction is made from the center to the periphery by gradually pulling the needle towards you. Recommendations for limiting physical activity are given. After administration of the drug, the patient noted pain during the first day after administration. The pain was shooting. With an interval of 7, 14 days, repeated injections were made under ultrasound control. A total of 3 injections were made.

Control MRI 6 months after treatment showed an increase in tissue density in the area of meniscus injury, which indicates replacement of the damaged tissue with new connective tissue. The patient also noted an improvement in the condition of the knee joint (assessed on the Lisholm, Lekken, VAS, and WOMAC scales). All scales showed positive dynamics. MRI at 18 months shows no negative dynamics compared to MRI at 6 months after injection.

All patients have no evidence of relapse during follow-up.

The claimed method is effective in terms of the achieved results, since it works only with the affected area, safety for the patient, since it uses his own blood, the possibility of treatment on an outpatient basis, has no analogues and meets the criteria of patentability.

Claims (6)

1. A method of treating damage to the medial meniscus without reaching the articular surface bordering the joint cavity by the method of intra-articular injection, including preliminary instrumental examination using MRI of the injured region of the joint, determining the zone of degenerative restructuring of the meniscus and introducing a therapeutic composition into the area of damage that stimulates the restoration of destroyed tissue , characterized in that a platelet mixture obtained from one's own blood is used as a therapeutic composition, which, under ultrasound control, is delivered to the zone of degenerative restructuring of the meniscus by means of the percutaneous injection of a needle into the meniscus, produced from the popliteal fossa, while the administration of the therapeutic composition is performed before filling them of the entire volume of damaged meniscus tissue. 2. A method of treating meniscus injury by intra-articular injection according to claim 1, characterized in that the therapeutic composition is administered directly through the posterior surface of the joint into the thickness of the meniscus and into the border zone of the capsule at the point closest to the posterior horn of the medial meniscus. 3. The method according to claim 1, characterized in that the platelet mixture is administered in an amount of 0.5. 4. The method according to claim 1, characterized in that when the needle is withdrawn, 0.5 ml of platelet mixture is additionally injected into the border zone of the joint capsule. 5. The method according to PP. 1 and 2, characterized in that the platelet mixture is injected with a puncture needle. 6. The method according to claim 1, characterized in that the filling of the affected area with the drug is performed from the center of the area to its periphery.