RU2364361C1 - Method of repair osteogenesis stimulation in treatment of fractures - Google Patents

Abstract

FIELD: medicine; traumatology and orthopaedics.

SUBSTANCE: stimulation of repair osteogenesis in delayed union, and treatment of ununited fracture or protracted non-union is ensured by injections of dispersed biomaterial Alloplant dissolved in physiologic saline in the ratio biomaterial 50 mg per saline 5-15 ml. The biomaterial is injected in soft tissues adjacent to the site of fracture or protracted non-union, and (or) hypodermically in projection of pathology. One session includes 1-10 injections, 0.1-15 ml each. Number of sessions is 1-10 for therapeutic course every 1-7 days.

EFFECT: more rapid regeneration of bone tissue, reduced injuries, eliminated postoperative complications, reduced treatment time.

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Description

The invention relates to medicine, namely to traumatology and orthopedics, and can be used in the complex treatment of fractures, to stimulate reparative osteogenesis with delayed bone consolidation, as well as for the treatment of an unhealed fracture or false joint.

It is known that myelopeptides are used to stimulate osteogenesis of natural bone marrow immunomodulators (Blinkov Yu.Yu. Study of the effect of myelopin and its components on immunological reactivity and reparative osteogenesis. Abstract of dissertation, candidate of medical sciences Kursk State Medical University. Kursk, 2000). Based on them, the immunocorrecting drug myelopid was developed, which is a mixture of highly purified low molecular weight peptides isolated from the supernatant of bone marrow cell culture. The target of the drug are the organs of the immune system of the spleen and thymus, functional activity and morphology (through the quantitative and qualitative composition of the cellular elements of white blood) which are closely related to the processes of bone marrow formation and bone restoration. The drug is administered subcutaneously during the first 6 days after the fracture in doses of 0.005; 0.5; 5; fifty; 500; 5000 mcg / kg. However, the drug causes pronounced morphological and functional changes in the spleen and thymus, a phase violation of the ratios of the populations of white blood cells, which limits its use in people with blood diseases.

The introduction between the bone fragments of 10-15 ml of autologous blood taken from a vein is known. Injections of autologous blood alternate with the introduction of 1 ml of alcohol in 5 ml of a 1% solution of novocaine at the fracture site. The procedure is performed every other day for 3-5 injections per treatment course (Krasnov AF, Miroshnichenko VF, Kotelnikov GP, “Traumatology”, a textbook for doctors, Moscow, 1995, p.75).

The disadvantage of this method is the danger of infection and, as a consequence, the development of osteomyelitis against a background of reduced immunity. In addition, the method is not effective enough.

It is known to use the osteomatrix biocomposite material based on bone allocollagen, bone allosulfitated glycosaminoglycans and hydroxyapatite (Merkulov V.N., Lekishvili M.V., Dorokhin A.I. // Bulletin of Traumatology and Orthopedics) for the treatment of sluggish consolidating fractures and false joints. 2000, No. 4, p.22-25).

The disadvantage of this method are:

- injuries, since the introduction of the drug requires incision of the fracture site or the false joint;

- the need for general anesthesia;

- the need for the most complete filling of the bone defect.

Closest to the proposed one is a method for optimizing reparative osteogenesis (RF patent No. 2315580, IPC АВВ 17/56, published on January 27, 2008), which involves introducing a fractured zone or a false joint mixed with autoblood into the bone marrow canal Alloplant for scleroplasty.

The disadvantages of the method are:

- the inconvenience of the procedure due to the need for preliminary grinding of the plates of the biomaterial into crumbs;

- the possibility of aseptic disturbances in the preparation of suspensions;

- the invasiveness of the method due to the large size of the Gordeev needle and the need for access to the medullary canal.

The objective of the invention is to develop an effective and non-traumatic method of treating fractures aimed at regenerating bone tissue, providing a quick clinical effect, the stability of the results, as well as the convenience and simplicity of the procedure.

The problem is solved by the method of stimulating reparative osteogenesis in the treatment of fractures, including the introduction of the Alloplant biomaterial into the fracture zone or false joint, in which, in contrast to the prototype, soft tissues and (or) subcutaneously are injected subcutaneously into the projection of the pathology of the dispersed Alloplant biomaterial, diluted in physiological solution in the ratio of 50 mg of biomaterial per 5-15 ml of solution, in the amount of 1-10 injections per session, 0.1-15 ml in one injection tion, the number of sessions 1-10 per course of treatment with an interval of 1-7 days in between.

It is known to use the dispersed Alloplant biomaterial (DBMA) to stimulate the reparative regeneration of damaged tendons and ligaments (RF patent No. 2284768, IPC АВВ 17/00, publ. 10.10.2006). According to this invention, injections of DBMA solution into the damaged area contribute to the formation of collagen tendon fibers and the formation of dense connective tissue. This is due to the well-known regenerative properties of Alloplant biomaterial (RF patent No. 2189257, IPC A61L 27/00, publ. September 20, 2002).

The proposed method provides a new therapeutic effect in the treatment of fractures: accelerating all stages of healing of fractures, reducing the rehabilitation time and preventing possible complications. The achievement of this result is due to a new property identified by the authors: attraction of cambial osteogenic cells to the injection site, that is, to the fracture site, as well as the induction of their proliferation and differentiation. In addition, the property of DBMA to activate various directions of differentiation of osteogenic cells, in particular, into fibro- and chondroblasts, was noted. For example, in the absence of optimal immobilization and comparison of fragments or in the case of a false joint, DBMA accelerates the maturation and differentiation of fibro- and chondroblasts, which accelerates osteogenesis.

Established serial production of DBMA and the proposed method of administration provide convenience in the implementation of the procedure, its safety and low injuries.

The method is as follows.

A solution for injection is prepared, for this, 5-15 ml of physiological saline is injected into a sterile vial with standard packaging of 50 mg of DBMA. The concentration of diluted biomaterial depends on the nature of the fracture. The DMBA solution is drawn into a syringe and directly injected into the soft tissues and / or subcutaneously in the projection of the pathology adjacent to the site of the fracture or false joint. With a fresh fracture, fragments are first compared and immobilized. For fractures of small bones (hands, feet, etc.), 0.1 to 3.0 ml is injected per injection, medium - from 3.0 to 5.0 ml, and large - from 5.0 to 15.0 ml solution. The procedure is carried out in compliance with the strictest asepsis, taking into account the anatomical structure and with minimal trauma to the surrounding tissues. Depending on the characteristics of the fracture, the injection can be from one to ten in one session. Treatment is carried out in courses with the number of sessions 1-10 per treatment course with an interval between sessions of 1-7 days.

Example 1

Patient B., 45 years old, was admitted to the trauma unit with a diagnosis of closed fracture of the middle 1/3 of the right thigh with displacement of fragments (Fig. 1). On admission, skeletal traction was applied. After 20 days, osteosynthesis with a metal plate was performed. 10 days after removal of the sutures, the patient was released for outpatient aftercare. During the entire treatment period, pain was disturbed and a limitation of the functions of the right lower limb was observed. 6 months after the fracture, a clinical and radiographic study was diagnosed with post-traumatic pseudoarthrosis of the middle 1/3 of the thigh on the right (Fig. 2).

The treatment according to the proposed method courses. The first 2 courses of 4 sessions of injection of DBMA diluted in a concentration of 50 mg of biomaterial per 15 ml of saline. Injections were performed in the area of projection of the pseudoarthrosis into the area of soft tissues. For one session, 10 injections of 1.5 ml each were carried out, the interval between sessions was 3-4 days, and the interval between courses was 2 months. 5 months after the start of treatment, control radiography was performed, which revealed active growth of bone marrow (figure 3). Clinically manifested a decrease in pain. Another course of treatment was carried out from 4 sessions according to the above scheme. On the control x-ray after 3 months, filling of the diastasis between the fragments with full bone marrow was revealed. Clinically, the patient did not experience discomfort with a load on the limb. The pains completely disappeared. After this, another course of treatment was carried out from 4 sessions according to the above scheme. On the control x-ray after 7 months, a full callus was indicated. After another 9 months, a fully formed bone marrow canal with bone callus is visible on the radiograph (Fig. 4). Thus, consolidation of the false joint and restoration of the anatomical integrity of the femur were achieved without surgery.

Example 2

Patient K., 38 years old, was admitted to the emergency room with complaints of pain during exercise, limitation of movements and swelling in the right ankle joint. From the anamnesis - 2 hours ago I twisted my leg. Based on the clinical and radiological data, the diagnosis was made: a fracture of the outer ankle and posterior edge of the tibia of the right ankle joint without displacement of fragments. Immobilization with a plaster cast. 5 days after the injury (after the edema subsided), treatment was carried out according to the proposed method. The course of treatment included 3 sessions with a break of 4 days between the first and second sessions and 7 days between the second and third sessions. For injection, DBMA was diluted in saline based on 50 mg of biomaterial per 12 ml of saline. Each session consisted of 10 injections of 1.2 ml, which were carried out in soft tissues and subcutaneous fatty tissue of the fracture zone.

On the x-ray, 1 month after the injury, the complete consolidation of the fragments is determined. Clinically: the patient can fully load the leg, there is a moderate restriction of movements in the ankle joint, slight swelling of the soft tissues. The usual terms of fusion in this fracture (without injecting DBMA) are 2 months. After 6 months, a good anatomical and functional result was achieved.

Example 3

Patient P., 65 years old, turned to the emergency room with complaints of pain in the distal part of the right forearm, pain with axial load, limitation of movements, swelling. Clinically and based on the results of the radiograph, the diagnosis was made: a fracture of the radius in a typical place on the right without displacement of fragments. On admission, a plaster cast was applied.

5 days after the edema subsided, treatment was carried out according to the proposed method. A solution for injection was prepared at the rate of 50 mg DBMA per 10 ml of saline. The course of treatment included 1 session of 10 injections of 1 ml each. 14 days after the injury, the x-ray showed complete fracture consolidation. Hand movement was carried out without restrictions.

The proposed method was tested on 25 patients for the treatment of fractures, including false joints. In all cases, a good result and a reduction in treatment time were observed.

Thus, the proposed invention allows to increase the effectiveness of the treatment of fractures due to the special properties of the dispersed biologically active material Alloplant in combination with the method of administration of this material. The method is less traumatic, devoid of side effects and contraindications.

Claims (1)

A method of stimulating reparative osteogenesis in the treatment of fractures, comprising administering Alloplant biomaterial into the fracture or false joint zone, characterized in that the soft tissues and (or) are injected subcutaneously in the projection of the pathology of the dispersed Alloplant biomaterial diluted into saline in the ratio of 50 mg of biomaterial per 5-15 ml of solution, in the amount of 1-10 injections per 1 session, 0.1-15 ml in one injection, the number of sessions 1-10 per treatment 1-7 days with an interval between them.

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