EXPERIENCE WITH LONG BONES DEFECTS REPLACEMENT ON THE BASIS OF COMBINED USE OF TRANSOSSEOUS OSTEOSYNTHESIS AND OSTEOCONDUCTIVE MATERIALS IN CLINICAL PRACTICE
1Omsk State Medical University, Omsk, Russia,
2Russian Ilizarov Scientific Center of Restorative Traumatology and Orthopaedics, Kurgan, Russia
Infectious purulent inflammatory lesions of the bones present the actual problem of the modern medicine [1]. According to the foreign literature, the process of treatment and rehabilitation is associated with high financial and psychosocial costs, as well as with high rate of disability. Therefore, understanding the course of infectious processes and improvement in treatment outcomes are the first priority tasks for many studies [2, 3, 4]. In 12-61 % of cases, purulent complications lead to development of chronic osteomyelitis, which is one of the obstinate complications that cause long term working incapacity and disability [5].
Surgical activity for treating chronic osteomyelitis is up to 70 % [6]. At that one performs radical necrosequestrectomy with subsequent bone plastic surgery with use of Ilizarov’s technique and various artificial or biological implants [6, 7, 8].
Currently, the carbonic composite materials are widely used [9, 10, 11]. They have the little pore structure and function as the efficient osteoconductive matrix [12]. At the present time, the carbonic composite materials are used for craniofacial surgery, surgical treatment of degenerative and dystrophic disease, spinal disease, for replacement of bone defects in spine and extremities injuries, as well as for osteomyelitic, tuberculous and malignant lesions of the bones [13, 14].
The objective of the study – to improve the treatment results in patients with post-resection defects of the diaphyseal portion of the long bones on the basis of application of transosseous osteosynthesis in combination with osteoconductive materials.
The tasks of the study:
1) to develop the algorithm for use of the carbonic implants for replacement of various types of postresection defects of the long bones in clinical practice;
2) to investigate the treatment results in the patients with various types of the implants.
MATERIALS AND METHODS
The materials included 25 clinical cases of the patients who had received the inhospital treatment in the purulent surgery unit in Omsk Clinical Medicosurgical Center on the basis of the traumatology and orthopedics unit No.4 of Russian Ilizarov Scientific Center of Restorative Traumatology and Orthopaedics.
The inclusion criteria were the age from 18 to 70, presence of long bone defects, the written consent from the patient. The exclusion criteria were pregnancy, breast feeding, presence of severe decompensated concurrent pathology, inordinate drinking, previous or present use of drugs, presence of abnormal development of bone tissue, irreversible changes in soft tissues as result of damage of the magistral vessels.
All patients were informed about the conditions of the study, the offered and alternative treatment techniques and the conclusion from the ethical committee, Omsk State Medical University.
The patients were distributed into two groups with similar age and gender: the main group (15 patients) and the comparison group (10 patients).
The first group (the comparison group) was used for the retrospective analysis of the medical records of 10 patients treated in the purulent surgery unit in Omsk Clinical Medicosurgical Center in 2014-2016. The main surgical technique was radical necrosequestrectomy with opening of the spinal channel and resection of ends of fragments. After that, the plastic surgery for a formed defect was conducted with use of bone cement and subsequent draining of the postsurgical wound with silicone non-flowing drains.
In the second (main) group 15 patients received the carbonic nanostructural implant (Fig. 1). The implant was used according to the following protocol. The region of a bone defect was opened from a skin and soft tissue incision (recurrent approach during primary surgery). A defect of the long bone diaphysis was replaced with the carbonic nanostructural implant. The implant sizes corresponded to the sizes of a resected part of a bone that was provided by means of intrasurgical preparation with the burrs. Additional stabilization was realized with the external device with fixing the injured and adjacent (if it was necessary) segments of the extremity. Considering the necessity of distraction in the region of a lesion, the first stage included the mounting of the external fixing device. Then the implant (prepared in concordance with the sizes of a defect) was placed.
Figure 1. The appearance of the nanostructured carbon implant
The implants were used at the stage of persistent remission of the infectious process after carrying out the control analyses: general blood analysis, erythrocyte sedimentation reaction, C-reactive protein.
During mounting the device, first of all, the basic supports were mounted with maximal distance from an injured region of the segment with consideration of topography of vascular and neural stems and anatomy of muscles and a bone. The reducing supports were placed at the level of proximal and distal ends of fragments (at least 10 mm from a defect). Positioning of the supports was associated with the geometry of the implant and necessity for its placement into the proximal and distal marrowy canal for the distance of 5 mm. Aseptic dressings were placed onto the regions of input and output of the pins. Then the wound was sutured in layer by layer manner, and the postsurgical wound was drained with the silicone non-flowing drains.
The analysis of the data was based on the results of the clinical and X-ray examinations, estimation of life quality with SF-36.
The main criteria for estimation of the short term outcomes of the treatment were the timeframes and a type of a postsurgical wound healing.
Also during the process of dynamic observation we estimated the absence of recurrent diseases (fistula opening, development of pathological fractures, X-ray picture), and correction of orthopedic problems.
The X-ray examinations were conducted before surgical intervention for verifying the diagnosis and location of the process, as well as after the surgical treatment on the days 1, 30, 60 and 90 for estimation the time course of reparative processes in the bone wound.
The statistical analysis of the results was conducted with consideration of the observation units, a type of estimated data and the study design. The median (P50) and the percentiles of the variational series (lower Q1 and upper Q3 quartile) were used for description of the quantitative variables. Mann-Whitney U-test was used for comparison of the quantitative data (two independent populations).
The p value of 0.05 was considered as the critical level of significance in all procedures of the statistical analysis. The biometrical analysis was conducted with STATISTICA 6.0.
RESULTS
The age of the patients was 48 (36-54) in the main group and 49 (37-53) in the control group (U = 74.00, p = 0.978).
The patients were distributed according to their gender: the main group – 11 men (73.3 %) and 4 women (26.7 %), the control group – 7 men (70 %) and 3 women (30 %).
Refusal from analgetics and, as result, management of pain syndrome were on the day 4 (3-5) in the main group and on the day 3.5 (3-5) in the control group (U = 70.5, p = 0.806).
Dosed physical load to the operated extremity was on the week 3 (2-4) in the main group and also on the week 3 (1-6) in the control group (U = 74.0, p = 0.978).
The developing callus was visualized on the X-ray image from the week 8 (Fig. 2, 3).
Figure 2. X-ray imaging and the developing callus in the main group (8 weeks)
Figure 3. X-ray imaging and the developing callus in the control group (8 weeks)
Full load to the operated extremity was on the week 3 (2-4) in the main group and also on the week 3, but with higher variability (1-6) in the control group.
The analysis of uniformity of development of callus showed the good uniformity along the whole fracture in the main group, with periosteal pattern at the initial stages of development and with ingrowth into the implant on all sides.
The most reliable sign of fracture consolidation was absence of pain and of edema increase during the clinical testing.
SF-36 was used for analysis of life quality. There were not any statistically significant differences between the groups in relation to PH and MH before and after the surgical treatment.
Some trends were identified during the analysis of the treatment outcomes in dependence on size of a bone defect. The defect size was 3 cm (2.8-3.8) in the main group. This value was 5.25 cm (2-7) in the control group. Despite the significant variability in the borders of a defect in the control group, the differences were not statistically significant (U = 58.5, p = 0.367).
The positive outcomes of the treatment were observed in 60 % of the cases in the main group and in 20 % in the control group.
The further analysis of each group showed that the size defect was 2.8 cm (2.5-3.0) in the cases with the positive treatment outcomes in the main group. The defect size was 3.95 cm (3.58-4.4) in the patients of the same group with requirement for additional surgical intervention (Fig. 4). The differences between these values were statistically significant (p < 0.001).
The results for the mean defect size with positive and negative outcomes of the treatment were 10 % and 15 % correspondingly according to the uniform classification of long bones defects (Barabash Yu.A., Barabash A.P.) [15].
Figure 4. The defect size in the main group with positive and negative treatment outcomes (the median value)
Clinical cases
Clinical case No.1
The patient G, age of 56, was treated during 18 days. The diagnosis was: “Chronic posttraumatic osteomyelitis of the left tibial bone, a fistula type” (Fig. 5).
Figure 5. The two-plane X-ray images of the left leg in the patient G. before surgery
The patient received the surgery: correcting osteotomy, fixation of the left leg bones with Ilizarov device, replacement of a defect with the carbonic implant. The size of the replaced defect was 2.5 cm. The X-ray control examination was conducted on the first day after the surgery (Fig. 6). The postsurgical period was without complications. The wound healed with the primary intention. The sutures were removed on the day 15. Consolidation was after 10 weeks. The clinical testing showed the insignificant pain syndrome. Ilizarov device was partially dismounted. It was fully dismounted after 14 weeks. The total time of the follow-up was 2 years (Fig. 7). There were no complications and recurrent process of chronic osteomyelitis during that period.
Figure 6. The two-plane X-ray images of the left leg in the patient G. after surgery
Figure 7. The two-plane X-ray images of the left leg in the patient G. two years after surgery
Clinical case No.2
The patient K., age of 36, was treated during 28 days. The diagnosis was “Chronic postsurgical osteomyelitis of the middle one-third of the left humerus diaphysis, a fistula type” (Fig. 8).
Figure 8. The two-plane X-ray images of the left humerus in the patient K. before surgery
The patient received the surgery: necrosequestrectomy, replacement of a defect with the carbonic implant, Ilizarov device fixation. The control X-ray examination was conducted within 24 hours after the surgery (Fig. 9). The postsurgical period was without complications. The wound healed with primary intention. The sutures were removed on the day 17. The patient was discharged in satisfactory condition for outpatient treatment. By the moment of 14th week some complications appeared: a fracture of the pins, disordered integrity of bone regenerate as result of instability of bone fragments and recurrent opening of the fistula (Fig. 10).
Figure 9. The two-plane X-ray images of the left humerus in the patient K. after surgery
Figure 10. The two-plane X-ray images of the left humerus in the patient K. after the fracture
CONCLUSION
1. The use of the nanostructural carbonic material for replacement of defects optimizes the formation of bone regenerate and provides the positive osteointegration on the border between the bone and the implant.
2. The developed technique improves the treatment outcomes in patients with defects in combination with extrafocal transosseous fixation for defect replacement not more than 10-15 % of segment length.
3. The use of the carbonic nanostructural implant does not increase the duration of the surgical treatment and has no statistically significant differences from the technique of bone cement filling.
REFERENCES:
1. Vinnik YuS, Shishatskaya EI, Markelova NM, Zuev AP. Chronic osteomyelitis - diagnosis, treatment, prevention. A review of the literature. Moscow Surgical journal. 2014; 2: 50-53. Russian (Винник Ю.С., Шишацкая Е.И., Маркелова Н.М., Зуев А.П. Хронический остеомиелит - диагностика, лечение, профилактика. Обзор литературы // Московский Хирургический журнал. 2014. № 2(36). С. 50-53)
2. Klyushin NM, Naumenko ZS, Rozova LV, Leonchuk DS. Microflora of humerus chronic osteomyelitis. Genius of Orthopedics. 2014; 3: 57-59. Russian (Клюшин Н.М., Науменко З.С., Розова Л.В., Леончук Д.С. Микрофлора хронического остеомиелита плечевой кости // Гений Ортопедии. 2014. № 3. С. 57-59)
3. Cook GE, Markel DC, Ren W, Webb LX, McKee MD, Schemitsch E. Infection in Orthopaedics. J. Orthop. Trauma. 2015; 29(12): 19-23
4. Tribble DR, Conger NG, Fraser S, et al. Infection-associated clinical outcomes in hospitalized medical evacuees following traumatic injury trauma infectious disease outcome study (tidos). J. Trauma. 2011; 71: S33-S42
5. Rozova LV, Godovykh NV. Comparative characteristics of microflora species composition in chronic posttraumatic and hematogenic osteomyelitis. Genius of Orthopedics.2014; 2: 56-59. Russian (Розова Л.В., Годовых Н.В. Сравнительная характеристика видового состава микроорганизмов при хроническом посттравматическом и гематогенном остеомиелите // Гений Ортопедии. 2014. № 2. С. 56-59)
6. Nikitin GD, Rak AV, Linnik SA. Surgical treatment of osteomyelitis. St. Petersburg: Russian Graphics, 2000. 288 p. Russian (Никитин Г.Д., Пак А.В., Линник С.А. Хирургическое лечение остеомиелита. СПб. : Русская графика, 2000. 288 с.)
7. Stolyarov EA, Batakov EA, Alekseev DG, Batakov VE. The substitution of the residual bone cavity after necrosectomy at chronic osteomyelitis.Genius of Orthopedics. 2009; 4: 11-16. Russian (Столяров Е.А., Батаков Е.А., Алексеев Д.Г., Батаков В.Е. Замещение остаточных костных полостей после некрсеквестрэктомии при хроническом остеомиелите // Гений ортопедии. 2009. № 4. С. 11-16)
8. Vinnik YuS, Shishatskaya EI, Markelova NM, Shageev AA, Horzhevskiy VA, Peryanova OV, et al. The use of biodegradable polymers for the replacement of bone cavities in chronic osteomyelitis. Herald of Experimental and Clinical Surgery. 2013; 6(1): 51-57. Russian (Винник Ю.С., Шишацкая Е.И., Маркелова Н.М., Шагеев А.А., Хоржевский В.А., Перьянова О.В. и др. Применение биодеградируемых полимеров для замещения костных полостей при хроническом остеомиелите // Вестник экспериментальной и клинической хирургии. 2013. Т. VI, № 1. С. 51-57)
9. Skryabin, VL, Denisov AS. The using of carbon nanostructured implants to replace post-resection defects in neoplastic and cystic lesions of bone: Clinical Guidelines. Perm, 2011. 19 p. Russian (Скрябин В.Л., Денисов А.С. Использование углеродных наноструктурных имплантов для замещения пострезекционных дефектов при опухолевых и кистозных поражениях костей. Клинические рекомендации. Пермь, 2011. 19 с.)
10. Čolović B, Milivojević D, Babić-Stojić B, Jokanović V. Pore Geometry of Ceramic Device: the Key Factor of Drug Release Kinetics . Science of Sintering. 2013; 45: 107-116
11. Suresh Kumar G, Govindan R, Girija EK. In situ synthesis, characterization and in vitro studies of ciprofloxacin loaded hydroxyapatite nanoparticles for the treatment of osteomyelitis. Journal of Materials Chemistry B. 2014; 2: 5052-5060
12. Egol KA, Nauth A, Lee M, Pape HC, Watson JT, Borrelli JJr. Bone Grafting: Sourcing, Timing, Strategies, and Alternatives. J. Orthop. Trauma.2015; 29(12): 10-14
13. Borzunov DYu, Shevtsov VI, Stogov MV, Ovchinnikov EN. Analysis of carbon nanostructured implants application experience in traumatology and orthopedics. Priorov Bulletin of traumatology and orthopedics. 2016; 2: 77-85. Russian (Борзунов Д.Ю., Шевцов В.И., Стогов М.В., Овчинников Е.Н. Анализ опыта применения углеродных наноструктурных имплантов в травматологии и ортопедии // Вестник травматологии и ортопедии им. Н.Н. Приорова. 2016. № 2. С. 77-85)
14. Vandrovcova M, Bacakova L. Adhesion, growth and differentiation of osteoblasts on surface-modified materials developed for bone implants. Physiol. Res. 2011; 60(3): 403-417
15. Barabash YuA, Barabash AP. Unified classification of long bone defects. In: Elizarov reading: «Bone pathology: from theory to practice»: materials of scient.-pract. conf. with int. participation. Kurgan, 2016. 63-64 p. Russian (Барабаш Ю.А., Барабаш А.П. Унифицированная классификация дефектов длинных костей . Илизаровские чтения: «Костная патология: от теории до практики» : материалы науч.-практ. конф. с междунар. участием. Курган, 2016. С. 63-64)