RU2253393C1 - Method for treating comminuted fractures of long tubular bones - Google Patents

Abstract

FIELD: medicine, traumatology.

SUBSTANCE: osseous defect after filling with collapan and usage of metallofixative should be covered with absorbable collagen film that provides orientation of osseous regenerate's organization.

EFFECT: higher efficiency of therapy.

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Description

The invention relates to medicine, in particular to traumatology and orthopedics, and can be used to treat comminuted fractures of long tubular bones.

The ever-increasing severity of skeletal bone injuries, as well as the high frequency of post-traumatic complications associated with impaired reparative osteogenesis and nosocomial infection, prompts the search for means and methods of influencing bone repair and prevention of purulent complications.

Open and closed comminuted fractures of type B and C (according to the AO / ASIF classification) are characterized by significant soft tissue damage, the presence of a large number of bone fragments and bone defects. The latter arise due to the inability to accurately compare small bone fragments or when removing bone fragments during the initial surgical treatment for open fractures (Bialik E.I., Markov S.A., Boyarshinova O.I. Optimization of bone repair processes in the treatment of complex diaphyseal fractures in victims with combined and multiple trauma // Materials of the city scientific-practical conference, Moscow, 2000, S.50-55).

The use of bone autoplasty in combination with metal fixation can solve the problem of replacing the bone defect and partially the problem of stimulating bone regeneration in this area (Lazarev A.F., Gorokhov V.Yu., Kesyan G.A., Urazgildeev R.Z. Application of the "Collap" for total hip arthroplasty // Collection of abstracts "Bioimplantalogy on the threshold of the 21st century", Moscow, 2001, pp. 84-85).

However, bone autoplasty, along with obvious advantages, has several disadvantages. First of all, this is a fairly quick lysis and the possibility of purulent-inflammatory complications, as well as the application of additional surgical trauma during the autograft sampling.

Attempts to prevent the soft tissue from being interposed in the defect zone and to create favorable conditions for regeneration by fencing the defect zone through the use of artificial polymeric materials in the form of tubes and films are also not effective enough.

A known method of using a polymer tube of polytetrafluoroethylene, put on bone fragments in the area of the defect in combination with metal fixation (Nyman R, Magnusson M, Sennerby L, Nyman S, Lundgren D. Membrane-guided bone regeneration. Segmental radius defect examined in the rabbit. J / Acta Orthop. Scand. 1995 Apr; 66 (2): 169-173).

The disadvantage of this method is the lack of osteoinductive properties of this material and the implantation technique, leading to the formation of locking plates on bone fragments.

In recent years, complex preparations based on hydroxyapatite have found wide application for filling bone defects and stimulating osteogenesis. These bioimplants have properties that provide optimal conditions for reparative regeneration during the formation of primary callus and its reconstruction into full bone tissue.

Closest to the proposed method for the treatment of comminuted and intraarticular fractures is a method where a bone defect before metal fixation was filled with a valve (S. M. Slostin, A. V. Strelkov, V. A. Topilsky, V. A. Konovalov. “Using a valve in a complex treatment of fractures of long tubular bones ”// Materials of the scientific conference“ Modern medical technologies and prospects for the development of military traumatology and orthopedics ”, St. Petersburg, 2000, p.182).

The disadvantage of this method is the relatively long treatment of fractures, because when this drug is introduced into the area of the defect, even when the soft tissues are carefully sutured, in the form of a sleeve, the valve cannot be excluded from the defect zone due to the mobility of the surrounding soft tissues.

The present invention is a method of treating comminuted fractures of long tubular bones, which allows to reduce the treatment time by stimulating the regenerative properties of the bone.

The problem is solved by the method consisting in the fact that, in addition, the bone defect after filling with the valve turns into an absorbable collagen film.

The effectiveness of the proposed method was studied in an experiment on animals (outbred dogs of both sexes weighing an average of 20 kg).

In order to create an experimental bone defect under intramuscular anesthesia (calypsol and rometar), a circular diaphysis defect of 5 mm in length was formed with the help of a Jigley saw in the middle third of the right femur, then bone osteosynthesis was performed with a metal plate and screws. In the work, we used a preparation based on artificial hydroxyapatite and collagen collagen (manufactured by Intermedapatite), as well as a collagen semipermeable film.

From the next stage, animals are divided into 3 groups.

In the first group (10 animals), the bone defect was not filled with anything, the wound was sutured tightly (control group).

In the second group (10 animals) granules of a valve were placed in a bone defect, the wound was sutured in layers.

In the third group (9 animals), collapse granules were placed in the bone defect, the defect was covered with an absorbable collagen film, and the wound was sutured in layers.

X-rays were taken immediately after surgery, after 30 days, 2 and 3 months. At the same time, the animals were removed from the experiment and the material from the area of the bone defect was sent for histological examination.

A series of experiments revealed a high biocompatibility of the valve and collagen film with animal tissues. In any of the series, suppuration of the postoperative wound, as well as soft tissues around the implants, was not observed. Around the implanted materials, both in the early and late stages of the study, a very weak cell response is histologically revealed.

In a series of experiments where a valve was inserted into the bone defect and was not covered by a collagen film, the implant migrated purely mechanically, due to the movement of adjacent muscles outside the defect, most of it turned out to be freely lying in the muscle mass. This did not happen if the bone defect was additionally covered by a collagen film.

According to x-ray, compared with the control, a more pronounced bone formation was noted in a series of experiments using a valve and, especially, with the integrated use of a valve and a collagen film. Already in the early stages (30 days) in 2 and, especially, in 3 series of experiments, a “veil” of the primary corns in the area of the bone defect is revealed. A periosteal reaction in the collagen film coating zone is not observed. 3 months after surgery, in all 9 (100%) animals of the third (main) group, the bone defect was filled with full bone regenerate, which was not observed in any of the animals in the control (group 1) group, and was also less pronounced in experiments using a valve without a collagen film - the formation of a full bone marrow was observed in 60% of cases (6 animals). Histological examination showed that the most active processes of osteogenesis occurred in the 3rd group of animals, while a newly formed bone was formed directly on the surface of the granules of the valve.

In the same group, remodeling of bone trabeculae and restoration of the cortical bone also proceeds most actively.

The use of an absorbable collagen film prevented the valve from migrating from the defect area, thereby prolonging its action. Prolonged (up to 1 month) biodegradation of the collagen film determines the optimal conditions for the development of primary bone marrow with its subsequent restructuring and restoration of the normal structure and function of the long tubular bone.

Based on the positive results of experimental studies, the proposed method of treatment was used in clinical practice in 3 patients. All have consolidated fractures. Purulent-inflammatory complications were not observed.

Clinical example 1

Patient S., 28 years old, was transferred to CITO from the Central Hospital of the city of Mytishchi on the second day after receiving an auto-injury, with a diagnosis of closed multi-fragmented bone fracture of the middle third of the right leg. On the second day after admission, the patient was operated on. During the operation, it was found: an extensive hematoma of soft tissues, edema, abrasions, a lot of small, freely lying fragments in the fracture area, and interposition of soft tissues. After removal of freely lying small bone fragments and reposition of the fracture area, defects in bone tissue were formed, which were filled with a valve. To ensure directed regeneration, the fracture region is covered (shrouded in the form of a sleeve) by a collagen film fixed by a ligature. Then, bone osteosynthesis with a metal plate was performed. Despite the severity of the fracture and extensive soft tissue bruises, no complications were observed. Fracture consolidation occurred after 8 weeks as a primary fusion, without signs of periosteal callus. Disability restored.

Clinical example 2

Patient D., 45 years old, was taken to the admission department of the CITO 3 hours after receiving an injury (falling from a height of 6 meters at a construction site) with a diagnosis of open comminuted fracture of the lower third of the left femur. Upon admission, it was found: a shock of the II degree, at the border of the middle and lower third of the left thigh along the front surface, a laceration of 4 by 3 cm in size with bloody discharge. Bone fragments protrude into the wound. Upon admission, the initial surgical treatment of the wound was made with excision of non-viable tissues, fragments freely lying in the wound canal were removed, and bone fragments protruding from the wound canal were resected. The bone tissue defect was loosely filled with a valve after reposition of the fragments with a needle-mounted apparatus mounted on the basis of the Ilizarov apparatus. The fracture area is shrouded in a collagen film fixed by a ligature. Due to the extensive defect, no sutures were applied to the skin. The postoperative period was uneventful. The wound healed due to active marginal epithelization on the 20th day, skin plasty was not required. No complications were observed. The patient was discharged on the 25th day after the operation. Dynamic observation revealed active reparative regeneration of bone tissue in the fracture area. Fracture fusion occurred after 11 weeks, the device was removed, recovery came, disability was restored completely.

Thus, the semipermeable collagen film, which covered the site of implantation of the valve in the fracture region, contributes to the localization of the valve and prevents its migration, thereby enhancing and prolonging the action of the valve.

Claims (1)

A method for the treatment of comminuted fractures of long tubular bones, including the use of a valve and a metal fixer, characterized in that an additional bone defect after filling with a valve is wrapped with an absorbable collagen film.