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THE ANALYSIS OF EFFECTIVENESS OF OSTEOSYNTHESIS METHODS IN PATIENTS WITH INJURIES TO FOREARM BONES Panov A.A., Kopysova V.A., Burnuchyan M.A., Khalaman A.G., Shashkov V.V.

THE ANALYSIS OF EFFECTIVENESS OF OSTEOSYNTHESIS METHODS IN PATIENTS WITH INJURIES TO FOREARM BONES

Panov A.A., Kopysova V.A., Burnuchyan M.A., Khalaman A.G., Shashkov V.V.

Novokuznetsk State Institute of Postgraduate Medicine,

All-Russian Scientific Practical Center of Shape Memory Implants,

OOO Grand Medica,

Novokuznetsk City Clinical Hospital No.5, Novokuznetsk, Russia

Medical Center of Healthcare CJSC Aramyants, Yerevan, Armenia

Fractures of diaphyseal segment of forearm bones consist 11.2-15.7 % among all skeletal injuries. In 50.6-77.5 % of cases, they are accompanied by displacement of bone fragments with requirement for reposition and osteosynthesis [1-3]. Reposition and preservation of stable position of bone fragments are hindered by some anatomical and functional features of the forearm: relationship of the paired bones which are connected with interosseal membrane, proximal and distal radioulnar joints, the curve of the radial bone, rotational movements of the forearm bones [4-6].
The use of the external fixation devices provides satisfactory stabilization of bone fragments. However correction of all types of displacement is often achieved with opened reposition. Placement of pins and nails (to the lesser degree) promotes the reactive inflammation of soft tissues, and it requires additional treatment or preliminary removal of pins (nails). Good results are achieved in 81.0-88 % patients [7]. However osteosynthesis with external fixation devices is the most optimal option for patients with fractures of bones of the forearm at two or more levels, fracture-dislocations and fragmented injuries.
The high amount of complications (up to 44 %) of intramedullary fixation with rectangular cross section rods (pins) and insufficient compression of bone fragments cause the high probability of rotation displacement and preliminary migration of the nail from the intramedullary channel. Therefore, external osteosynthesis is mainly used for fixation of the forearm bones [2, 4, 6, 8, 9]. After fixation with LC-DCP and LCP, good and excellent results are achieved in 98.2-96.1 %. It is acknowledged that external fixation (also with low invasive techniques) is not enough appropriate for complex fractures (type C2, C3) in patients with osteoporosis. Moreover, the price of dynamic (locking) plates with limited contact is quite high, and it prevents its wide-spread use [2, 10-12].
According to some authors, intramedullary fixation with locking nails in proximal and distal bone fragments is low traumatic, provides restoration of the length of the axis of injured bones, preservation of the radial bone curvature, removes the rotational stability of bone fragments and migration of nails. It is proved that anoxia reduces by 33.9 % 3 days after surgery, and after external osteosynthesis with LC-DCP – by 12.3 %. The time of union of bone fragments is 8-20 weeks, with good results in 96.4 % [5, 11, 13].
Medical technology of intramedullary fixation with memory-effect compression braces in treatment of patients with fractures shows the prospectivity of this technique. However the possibilities of the method for patients with fracture-dislocations, fragmented and bifocal fractures have been studied insufficiently [1].
Objective – to perform a comparative analysis of the results of extramedullary, intramedullary and transosseous osteosynthesis, and combination with adjunctive fixation of bone fragments with shape memory clamps in patients with single fractures and fractures in both forearm bones, as well as in patients with fracture-dislocations and multiple fractures.
    
MATERIALS AND METHODS

  The randomization method was used for selection of 153 medical records of the patients with single, combined diaphyseal fractures, fracture-dislocations and multiple fractures of the forearm bones in 2000-2017. The study group included the patients, the age < 18 and > 65. The trauma period was more than 2 days. The patients had the opened fractures with bone tissue defect > 50 mm. ICD-10 was used for estimation of location of patterns of the injuries.
According to the fixation techniques, the control group and the main group were separated. DCP, LC-DCP and LCP, Kirschner wire and Ilizarov devices were used for 78 (51 %) patients (the table 1). 75 (49 %) patients of the main group received the combined osteosynthesis (with additional fixation with shape memory clamps (the table 2).

Table 1
Osteosynthesis techniques in 78 (51.0 %) control patients in the subgroup without complications (61 (78.2 %))

 and in the subgroup with complications (17 (21.8 %)) of injuries to forearm bones

Subgroups of injuries, their location, characteristics and ICD-10	Osteosynthesis technique
	extramedullary	intramedullary	intramedullary + extramedullary	transosseous	Total
Uncomplicated fractures
radial bone fracture S52.3	16	5	-	-	21
ulnar bone fracture  S 52.2	8	5	-	-	13
fracture of both forearm bones  S 52.4	10	6	9	2	27
Total	34	16	9	2	61
Complicated fractures
radial bone fracture, dislocation of radioulnar joint (Galeazzi) S 52.3, S 53.3	5	2	-	-	7
ulnar bone fracture, dislocation of radial head (Monteggia) S 52.2, S 53.0	1	2	-	-	3
ulnar process fracture, dislocation of ulnar bone diaphysis (Malgaigne) S 53.1, S 52.0, S 52.2	-	1	-	-	1
multiple fracture of forearm bones S 52.7	1	-	-	5	6
fragmentary bilocal fracture of ulnar bone with bone tissue defect S 52.7	-	-	-	-	-
Total	7	5	-	5	17

Depending of characteristics of injuries, the control and main groups were divided into the subgroups. The subgroup of the patients with uncomplicated fractures included the single fractures of the radial bone diaphysis (S 52.3), fractures of ulnar bone (S 52.2) and both bones of the forearm (S 52.4). The subgroup of complicated fractures included the patients with fracture-dislocations (S 52.3, S 53.3, S 52.2, S 53.1, S52.0, S52.2), multiple fractures (bifocal, fragmented with intercalated fragments and bone tissue defects S 52.7) (the tables 1, 2).

Table 2.
Osteosynthesis techniques in 75 (49.0 %) patients of the main group in the subgroup without complications (45 (60.0 %))

 and in the subgroup with complications (30 (40.0 %)) of injuries to forearm bones 

Subgroups of injuries, their location, characteristics and ICD-10	Osteosynthesis technique
	intramedullary + braces	extramedullary + intramedullary + braces	transosseous + braces	fixation with bone graft	fixation with porous implant	Total
Uncomplicated fractures
radial bone fracture S52.3	15	-	-	-	-	15
ulnar bone fracture  S 52.2	13	-	-	-	-	13
fracture of both forearm bones  S 52.4v	14	3	-	-	-	17
Total	42	3	-	-	-	45
Complicated fractures
radial bone fracture, dislocation of radioulnar joint (Galeazzi) S 52.3, S 53.3	8	-	-	-	-	8
ulnar bone fracture, dislocation of radial head (Monteggia) S 52.2, S 53.0	2	-	2	-	-	4
ulnar process fracture, dislocation of ulnar bone diaphysis (Malgaigne) S 53.1, S 52.0, S 52.2	-	2	-	-	-	2
multiple fracture of forearm bones S 52.7	7	-	-	-	4	11
fragmentary bilocal fracture of ulnar bone with bone tissue defect S 52.7	-	-	-	2	3	5
Total	17	2	2	2	3	30

The methods of diagnostic examination and treatment corresponds to the standards of the program of government guarantee for free medical care (the Order by Government of RF, October 22, 2016, No.2229-r), and the Rules for Clinical Practice in the  Russian Federation (the Order by Russian Health Ministry, April 1, 2016, No.200n). There are the registration certificate and declaration of correspondence for the osteosynthesis fixators.
All patients received the opened reposition of bone fragments with subsequent osteosynthesis of injured bones with a chosen technique. The patients with fracture-dislocations received the reduction of a dislocation, and pin diafixation of distal segments of the radial and ulnar bones in Galeazzi fracture-dislocations. 3 patients with a multi-fragmented fracture of the upper one-third of the diaphysis of the ulnar bone received the porous cylindrical implant including the distal and proximal semicylindrical ledges with the internal end-to-end channel (the registration certificate No.2009/04558, point 2 of the application). The ulnar bone was fixed with the intramedullary nail, the implant – with ring-shaped devices and the shape memory form (the registration certificate No.2009/04558, the point 13 of the application).
2 The first stage was transosseous osteosynthesis for 2 patients with fragmented fracture of the lower one-third of the ulnar bone diaphysis and for 4 patients with multiple fractures including the intraarticular compression fracture of the distal segment of the radial bone. After 1-2 weeks, the reconstructive osteosynthesis was initiated with use of the S-shaped bracket with the intramedullary stem and with the fibular autograft for the patients with a comminuted fracture of the ulnar bone. The porous flat implants were used for replacement of a bone defect of the radial bone (the registration certificate No.2009/04558, the point 13 of the application, the declaration of compliance ROSS.RU.AYa79.D11341). The fixation was conducted with use of the intramedullary nails and S-shaped braces with termomechanic effect.
The patients with uncomplicated fractures received two weeks of external immobilization after external and intramedullary osteosynthesis in combination with the shape memory clamps. The patients with complicated fractures received 3.5-4 weeks of immobilization. The immobilization lasted up to fracture union in the control group.
The comparative analysis of efficiency of osteosynthesis techniques in the control and main groups, and in the subgroups with uncomplicated and complicated fractures considered the absence of inflammatory responses, migration (fracture) of constructs, quality of intrasurgical reposition and preservation of anatomical and topographical parameters of the forearm in the rehabilitation period up to union of fragments, terms and a type of union (according to criteria by Anderson) and a degree of recovery of volume of movements in the injured extremity (with use of Grace and Eversmann’s system [14]).
Statistica 6.0 was used for preparation of the data. χ²-test was used for estimation of significance of mean values and frequency of signs in the groups and the subgroups of the patients. Yates correction for continuity was used in presence of low frequency. For frequencies < 5, the method of Fisher’s four-fold tables was used. The critical level of significance for testing the null hypothesis was 0.05.

  RESULTS AND DISCUSSION

  The duration of operations in the main and the control groups was similar and depended on complexity of a fracture and osteosynthesis technique.
Unsatisfactory results of intramedullary fixation were conditioned by migration of a nail, diastasis between the fragments and absence of union in 3 (18.8 %) of 16 patients of the control group (two patients with fractures of both bones, 1 patient with a fracture of the ulnar bone). The recurrent surgical intervention with the intramedullary nail for compression of bone fragments was performed with S-shaped form with shape memory effect.
Due to a fracture of the plate and secondary displacement of bone fragments in a patient with a fracture of the ulnar bone, the osteosynthesis was performed with use of the intramedullary nail in combination with S-shaped clamp (the table 3).
After 2.5-3 months, the union of bone fragments was achieved, after 3.5-4 months – full recovery of function of the injured extremity in 44 (77 %) of 61 patients with uncomplicated fractures of the forearm, including 29 (85.3 %) of 34 patients after external osteosynthesis, in 8 (50 %) of 16 patients after intramedullary fixation (the table 3). 10 (16.4 %) of 61 patients received the union of bone fragments in 25-26 weeks after osteosynthesis, with two cases (the patients with a fracture of both bones of the forearm) of persistent (10 months) limitation of the radioulnar deviation (3-5°) and pronation-supination (5-7°) as compared to a healthy extremity. The results of treatment were satisfactory (the table 3).

Table 3
Results of osteosynthesis in control patients 

The comparative analysis in the control group with uncomplicated fractures of intramedullary and external osteosynthesis with the plates showed the statistically significant differences, with χ² = 5.329, p = 0.021.
In the main group, 42 (93.3 %) of 45 patients with uncomplicated fractures of the forearm bones showed the union of bone fragments with correct anatomical position in 8-10 weeks after osteosynthesis of single fractures, and recovery of full range of motions – after 12-13 weeks. The patients with a fracture of both bones of the forearm showed the union after 15-16 weeks (the table 4). 3 (6.7 %) patients with fragmented fractures of both bones showed satisfactory results of treatment, with correct anatomical union in 27-28 weeks after fixation (the table 4).

Table 4
Results of osteosynthesis in patients of main group

The comparative analysis of the results of external fixation in the control group with uncomplicated fractures and intramedullary fixation combined with termomechanical memory clamps in the main group did not show any statistical significant differences (χ² = 1.192, p = 0.275).
The number of unsatisfactory results reached 41.2 % in the control group in the patients with fracture-dislocations, multiple fractures of the forearm bones (the table 3). The union of bone fragments before 6 months from the moment of osteosynthesis and recovery of motions in the joints were achieved in only 8 (47.1 %) of 17 patients (Fig. 1). The comparative analysis of efficiency of treatment in the control patients with complicated and uncomplicated fractures showed the statistically significant differences, with χ² = 4.399, p = 0.036.

Figure 1 The picture of the X-ray images of the patient G., age of 33, with a fracture of the left ulnar bone and dislocation of the radial head (Monteggia injury): a) before; b) 6 weeks after combined osteosynthesis of the ulnar bone with titanium nail and the shape memory contractive clamp.

  
In the main group, 26 (86.7 %) of 30 patients with fracture-dislocations and multiple fractures of the forearm bones showed the union of bone fragments with preservation of relationships in the injured joints 5.5-6 months after osteosynthesis, the full recovery of motions – after 6-7 months (Fig. 2).

Figure 2 The picture of the X-ray images of the patient Ts., age of 52, with multiple fracture of the forearm bones (bifocal fracture of ulnar bone, fragmented fracture of ulnar bone): a) 6 months after extramedullary osteosynthesis; b) 2.5 weeks after removal of plates.

  
The limitation of radioulnar deviation (up to 5°) in 2 patients with Galeazzi fracture-dislocation, flexion-extension, pronation-supination (up to 10°) in the patients with Monteggia and Malgaigne fracture-dislocation persisted to 8-8.5 months and fully recovered in 10 months (the table 3, Fig. 3).

Figure 3 The picture of the X-ray images of the patient Shch., age of 45, with bifocal fracture of ulnar bone and fragmented fracture of radial bone: a) before treatment; b) 3.5 months after osteosynthesis.

The difference was statistically significant in comparison of the treatment results in the patients of the main and control groups with complicated fractures (χ² = 6.649, p = 0.010).

  DISCUSSION

  Most profile scientific publications recommend the opened reposition for multiple fractures, fracture-dislocations and fractures with rotational displacement of bone fragments [10, 11]. Its efficiency and, as result, the choice of fixing constructs highly depend on location and characteristics of an injury [8, 9, 14]. The necessary condition of osteosynthesis is removal of all types of displacement of bone fragments, minimization of surgical trauma, preservation of motion activity in early terms after surgery [3, 12].
It is generally accepted that osteosynthesis with external fixing devices (rods, rods and pins, Ilizarov G.A.) for patients with opened, multiple fractures and fracture-dislocations is the most optimal. Considering the clinical situational tasks, it was offered to use lots of combinations of transosseous osteosynthesis [1, 7].
Despite of the disadvantages of intramedullary fixation with nails, the intramedullary osteosynthesis was actually the single technique for simple (uncomplicated) fractures of the forearm bones in the Russian Federation in 90s of the previous century. With development of medical techniques and external plates for stable fixation without subsequent external immobilization, the techniques of external osteosynthesis have taken the leading place.
The efficiency of external fixation was higher in the comparative analysis of the results of external and intramedullary fixation with nails of square section in the patients with uncomplicated fractures of one or both bones (χ² = 5.329, p = 0.021).
The analysis of the scientific literature has shown that unsatisfactory results of external fixation as result of migration of screws, destabilization of bone fragments and absence of union were 12.5 %, and that external fixation poorly appropriate for patients with opened, multiple fractures and in patients with osteoporosis [4].
The positive qualities of intramedullary fixation (low traumatic effect, fixation of an injured bone along the whole length) were the foundations for improvement in the constructs and medical technologies. The locked nails, as well as nails for the radial bone with a curvature, have been offered for prevention of rotational mobility and creation of compression between bone fragments. The negative factor is absence of approximation of bone fragments along the width in oblique and fragmented fractures [3, 5].
The use of the shape memory constructs (S-shaped clamps, ring-shaped fixators) in combination with intramedullary fixation provides the adaptation and compression of bone fragments, sufficient stabilization of injured bones, with subsequent decrease in terms of external immobilization [1]. The comparative analysis of efficiency of external fixation and intramedullary fixation in combination with clamps with termomechanical memory showed the good results in the patients with complicated fractures of one or both forearm bones in 85.3 % and 95.2 % correspondingly (χ² = 6.649, p = 0.010, the difference is statistically significant).

  CONCLUSION

  External fixation and intramedullary osteosynthesis in combination with termomechanical effect clamps are equally efficient for patients with uncomplicated fractures (one or two bones).

Additional fixation of bone fragments with termomechanical effect clamps improves the results of osteosynthesis in patients with fracture-dislocations and multiple fractures of the forearm bones.