Parshikov M.V., Nikitin S.E., Yarygin N.V., Chemyanov G.I.

Evdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia

The methods for conservative treatment of diseases and bone injuries in the human are known from ancient times. In the end of 19th and in the beginning of 20th century, owing to improvement in surgical management and dissatisfaction with conservative management, the surgical techniques for correction of deformations and internal osteosynthesis became to develop [1-3].
Osteosynthesis (os, osteo – a bone; sintez – connection, conjunction) always includes the conservative and surgical methods.

The conservative management includes fixation external osteosynthesis (i.e. fixation of the fracture site with plaster splits, and today – with various modern orthoses) and extension (traction) – with traction (skeletal, adhesive plaster, cuff, cleolum) [2, 4, 6].

The surgical management of bone fractures includes the osteosynthesis: external, intraosseous and transosseous osteosynthesis. Currently, the surgical management also includes the transosseous external compression-distraction osteosynthesis.

The end of the 20th century can be characterized as the new stage of development of conservative external osteosynthesis, when various thermoplastic materials are used instead of plaster bandages. The term orthosis appeared – for designation of an external device for connection between injured parts of the extremity and improvement in structural and functional characteristics of neural, muscular and skeletal systems.

The term orthosis disappeared in 1990s in Russia. Its meaning was known by little number of doctors. Now orthoses are common for prescribing. However there is not any uniform opinion on clinical indications for such devices, and there are not any uniform guidelines for their indications [6-9].

Orthoses are divided into serial and individual. All orthoses (serial and individual), even ones with the same style (for example, corset, removable joint-immobilizer, knee wrap etc.) differ in constructive signs and in materials of production. It influences on their physical characteristics and, correspondingly, on the medical effect in each individual case [3, 7, 10].

The physician must know not only condition of stability of fracture site, stages of regeneration, but also technical and constructive features of orthosis. The specialist must be able to perform correct adaptation of a device to the extremity, to teach the patient to use it and to realize the dynamic follow-up of efficiency of influence at the stages of treatment.
During realization of the study, with the aim of identification of stage-by-stage approach and estimation of control of efficiency of use of necessary constructs, we introduced the new term orthosis therapy [11]. It is the technique for conservative osteosynthesis of fractures and their consequences. It consists in dynamic follow-up of the patient wearing the orthosis. The aim is monitoring of condition of the fixed segment, control for the construct, solution of the issue on improvement, changes in tactical solutions if necessary, clarification of features of influence in creation of optimal conditions for bone reparation, removal of developing deformations, joint stiffness and maximal recovery of functional capabilities. Currently, orthosis therapy should be included into the management system for most patients of traumatology and orthopedics profile.

– to prove expediency of application of orthesis therapy in treatment of fractures of long bones of extremities after unstable submersible osteosynthesis. 


The analysis of the dynamic follow-up included patients with fractures in different locations, false joints and defects of extremity bones. The age varied from 16 to 90 years, including 235 persons (45.7 %) at working age, whereas other patients (> 50 %) were older than 60, including 173 women (62.7 %). All these patients received the orthosis therapy with various constructs during treatment and rehabilitation in 2008-2018.
Previous surgical management was unsatisfactory. Moreover, 60 % of patients had the group 2 of disability.

The study was conducted in compliance with the requirements for the ethical committee of Evdokimov Moscow State University of Medicine and Dentistry which were developed in compliance with Helsinki Declare – Ethical Principles for Medical Research with Human Subjects 2000, and the Rules for Clinical Practice in the Russian Federation confirmed by the Order of Health Ministry of RF (19 June 2003, No.266). All participating persons gave their informed consent.
The statistical analysis of the results was realized with STATISTICA with non-parametrical methods. The data was presented as the median and quartiles – Me (Q25; Q75). Fisher’s exact test (F-test) and chi-square were used for comparison. The received differences c2 = 347.4; df = 16; p < 0.007 were < 95 % (p < 0.05) in possibility of precise diagnosis.

The used methods of examination were analysis of dynamics of bone regeneration with X-ray and CT images; testing questionnaires; Rivermead Mobility Index (RMI); Hauser Ambulation Index (HAI); MOS-36-Item Short-Form Health Survey (adapted Russian version with 6 scores for life quality assessment).

The incidence of complaints at the first visit was: pain at injury site (59.2-88.5 %); impossibility for axial load (44.9-65.2 %); disorder in active motion function of the extremity (64.9-90.3 %), i.e. its dysfunction.

The analysis of values of motion activity in patients with consequences of femur and leg fractures is presented in the table.

Table. Assessment of mobility of patients with consequences of injuries to the lower extremities at the first addres

Gait impairment                                    



Bed rest

(12.1 %)

(8.9 %)

Crutch walking without load to injured extremity

(68.2 %)

(55.9 %)

Crutch walking with dosed load to injured extremity

(15.0 %)

(26.1 %)

Walking with cane

(4.7 %)

(9.1 %)

Walking without additional supporting measures



Therefore, in case of dysfunction of femoral bone (68.2 %) and leg bones (55.9 %), the patients had significant functional insufficiency, which resulted in necessity for walking with crutches without load to the injured extremity. 12.1-8.9 % of patients adhered to strict bed rest. 


The first group included 265 patients (51.6 %) – with unstable osteosynthesis.
One of the main causes was incorrect selection of a fixator. Such situation was found in 105 cases (20.4 %). 2-4 weeks after surgical intervention (opened or closed reposition of fragments with subsequent metal osteosynthesis) and initiation of rehabilitation procedures, the patients addressed to our clinic for orthosis therapy, although the presurgical period did not include subsequent additional immobilization. At admission, all patients noted the recurrence of pain syndrome, which significantly increased during loading. The patients with lower extremity injuries used the additional supports during walking. However there were not any symptoms of instability.
The X-ray examination in various planes identified some errors in selection of the fixator and some technical disorders in realization of surgery:

1. Often the plates (length, width) and nails (diameter, length) were of lower sizes, resulting in inconsistence of fixation at different time intervals, but with preservation of correct axis of the segment.

2. In transosseous fixation, when the screws were in the single cortical plate, almost without penetration into contralateral one, even low load caused the migration.

At the same time, the control X-ray images showed the satisfactory adaptation of fragments. All operating surgeons estimated such osteosynthesis as unstable. These patients received the plaster splints, with refusal from load to the injured extremity. Then the plaster splints were changed to the orthosis.
For upper extremity injuries, the orthosis was selected according to conditions of maximally fast recovery of movements in joints near the injury site. The case of the orthosis is not exposed to axial loads. Therefore, the preference was given to orthoses with soft elastic cases, metal axial inserts and hinges with regulated volume of movements. For unstable osteosynthesis of lower extremities, the preference was given to individual orthoses with high rigidity of the case (polyethylene or carbon) and with hinges which lock movements. Such constructs had the possibility for correction of vertical axial loads to the injured extremity immediately after producing and before fracture union.

Clinical case

The patient K., age of 52, (Fig. 1). The diagnosis: “a spiral fracture of the tibia, an oblique fracture of the fibular bone”.

Figure 1. The patient K., age of 52. Diagnosis: spiral fracture of the tibial bone, oblique fracture of the fibular bone


At admission,the patient received the skeletal traction. On the tenth day after trauma, the plate osteosynthesis was performed. The control X-ray images (Fig. 1a) showed the osteosynthesis as incorrect. It was found that the fracture line was much longer than the plate. A solution was made to perform the additional external fixation of the extremity. For preservation of the fracture stability in conditions of achieved reposition of fragments, a preventive orthosis was made after removal of sutures – joint immobilizer for the ankle joint. 14 days after surgical intervention, the patient was trained to walk with crutches. The axial load was increased gradually. 7 days later, the patient could walk with minimal additional supporting or even without it (Fig. 1d). Orthosis therapy was included into the complex of additional conservative measures such as remedial gymnastics, classic massage and electric stimulation. 2 months after initiation of walking, the control X-ray images showed no signs of displacement (Fig. 1b). The clinical examination showed the increase in leg muscular hypertrophy and absence of edema, resulting in general decrease in leg and foot volume. The case of the orthosis was improved according to decreasing volume: the full contact between its surface and the injured extremity was achieved. The patient continued to walk with the orthosis. 6 months after initiation of walking, the control X-ray images (Fig. 1c) showed the fracture union. The local picture: skin surfaces of the foot and the leg with normal color, the knee function – normal. However stiffness was found in the ankle joint. It was corrected later.
Therefore, the use of an orthosis with adequate rigidity, and with the construct, which can be changed or adapted during the treatment process, depending on a situation, changed conditions or tasks, some possibilities for early functional activation of an injured segment and the whole patient appear, resulting in early recovery of function of an injured extremity, increasing mental and physiological activity and fracture union within the required time intervals.

A subgroup with complex and multi-fragmental fractures (160 patients, 31.2 %) included the patients with polytrauma and significant soft tissue injuries due to surgery. This condition caused some local perfusion disorders and, as result, absence of callus within the physiological time intervals. For activation of osteogenesis, the patients of this subgroup received the early functional load to the lower extremities. However the load to fixators increases significantly, and fractures of metal constructs and achievement of union are difficult to prevent even in stable osteosynthesis. The treatment is realized with appropriate immobilization or orthosis therapy. Certainly, orthosis therapy is better in modern conditions. It allows timely and adequate response to risks of decrease in rigidity of fixation of a fracture during the whole period of treatment by means of control and regulation of used constructs. According to our data, the optimal time for initiation of orthosis therapy is the second or third week after surgery. 

A clinical case

A patient K., age of 37. Diagnosis: “fragmented fractures of the left femur and bones of both legs”.
After skeletal traction (14 days), the patient received the locked fixation of the femoral bone (Fig. 2a), the locked fixation of the right tibia (X-ray images are absent), plate osteosynthesis for the left tibia (Fig. 2b). Because of unstable fixation of the femoral bone, the patient held strict bed rest within 4 months. The control frontal and lateral X-ray images of the femoral bone (Fig. 2a) showed that the distal end of the nail was insufficiently placed into a fragment from the fracture line, and it could not provide any stable fixation. The union of the femoral bone and the left tibia was absent. However the patient was activated. She was trained to stand on her right lower extremity. Recurrent osteosynthesis was conducted for stabilization of the fracture of the femoral bone. During the surgery, the surgeons faced with some technical difficulties – the rod could not be removed. It was decided to move it into the distal part, but locking was not achieved. The X-ray images of the femoral bones in two planes after recurrent surgery are presented in the figure 2c. In the postsurgical period, the left foot was non-supporting. On her right leg, she could stand not more than 5 minutes owing to pain in her leg. The curative and training orthosis was used for activation of the patient and for immobilization of the injury site (Fig. 2d). As for features of the construct, we would like to note a possibility for movements in both knee and ankle joint within the required range. Immediately after orthosis therapy, the patient could walk with crutches during partial load, and three weeks later with the walking stick. Three months later, X-ray examination found the union of leg and femur fractures (Fig. 2 e, f). The patient initiated her professional activity.

Figure 2. The patient K., age of 37 years. Diagnosis: splintered fractures of the left femur, fractures of both tibial bones


The second group included 143 patients (27.8 %) with migration of the fixator or its fracture without serious displacement. All patients received the fixation of fractures and the course of rehabilitation procedures with active training of movements in joints of the operated extremity. Additional external fixation was not conducted. After 6-12 weeks, the patients complained of pain feeling and edema in the surgery site which were absent before. The examination showed the correct axis of the extremity and painful loading. 48 cases (33.6 %) showed abnormal mobility. The control X-ray examination showed the migration of fixators or their parts. However such situation did not require for recurrent intervention in creation of conditions for rigid immobilization. Orthosis therapy was conducted for this purpose. 

A clinical case

A patient D., age of 23. Diagnosis: “a transverse fracture of the middle one-third of the femur”. The injury was as result of a road traffic accident (hit y a car). The skeletal traction system was applied after blocking of the fracture site. 14 days after the trauma, intraosseous osteosynthesis was conducted. Then the patient could walk with crutches without load to the operated extremity. However two weeks later, the patient complained of pain in the intervention site which caused difficulties for walking. The X-ray images showed a displacement of femur fragments along the width in conditions of intramedullary osteosynthesis; deformation of the nail with an angle inwards (Fig. 3).

Figure 3. The patient D, age of 23. The frontal X-ray image of the left femur: a transverse diaphyseal fracture in the middle one-third. Complicated intramedullary osteosynthesis

The patient refused from recurrent surgery. The primary examination showed the following moments: no load to the operated extremity, an attempt to find the abnormal mobility caused sharp pain; painful axial load. Movements in the nearest joints: limited active movements (increasing pain feelings), preserved passive movements.
Orthosis therapy was initiated from full exclusion of movements in knee and hip joints, and possible mobility in the fracture site. A special joint immobilizer was produced (Fig. 4). A load to the injured extremity was allowed. By the end of the fourth week of orthosis therapy, pain disappeared. During control examination, the construct was changed and adapted to initiate the movements the knee joint, i.e. shifted to the immobilizer for the femur and the hip joint (Fig. 5). One week later, the patient did not use the additional support (Fig. 6). The fracture union was found in 6 months after surgery. X-ray images (Fig. 7) show the stages of osteogenesis and formation of callus during orthosis therapy.

Figure 4. The patient D., age of 23. Appearance of the construct after initiation of orthesis therapy

Figure 5. Appearance of the orthesis «removable joint-immobilizer for femur and hip joint»

Figure 6. The patient D., age of 23. Appearance and walking on 5th week after the beginning of orthesis therapy

Figure 7. Frontal X-ray images of the left femur of the patient D., age of 23: a) 2 months; b) 4 months; c) 6 months after operation


The third group included 106 patients (20.6 %) with migration of the fixator or its fracture with displacement of fragments. These patients demonstrated the following features:
1) decompensated state within 6-12 weeks from surgery;

2) appearance or progression of pain feelings in the injured extremity;

3) the increase in the circumference of the operated segment (edema);

4) deformation or abnormal mobility (not all patients);

5) increasing pain during axial load to the extremity;

6) decreasing supporting ability and other functions of the operated extremity;

7) radiologic evidence of migration of the fixator, its fracture or fractures of components; serious displacement of bone fragments preventing the possibility of union.

It was not possible to achieve the positive result with use of only orthosis therapy for this category of patients. All of them required for additional surgery with detailed presurgical planning, analysis of causes of a complication during intervention, and realization of optimal recurrent osteosynthesis. Orthosis therapy for the injured extremity was conducted already in the postsurgical period for increasing stability with subsequent monitoring and correction of the construct if required. 

A clinical case

A patient M., age of 35. The diagnosis: “a transverse splintered fracture of the right femur in the upper one-third”. The injury was as result of a road traffic accident. He took a passenger seat in a light motor vehicle. After examination and preparations, the surgery was conducted: external fixation with the plate. During 14 days, the patient walked with crutches without load to the operated leg. Then the partial load was initiated. However 7 days later, he complained of progressing pain in the injury site. The hip deformation appeared. The control lateral and anteriolateral X-ray examination (Fig. 8a) showed an angle deformation, disordered integrity of the fixator and displaced fragments. A recurrent surgery was conducted – removal of the broken fixator, reposition of fragments and fixation with the reconstructive plate. Owing to location of the fracture on the border between the upper one-third and the middle one-third, presence of local posttraumatic osteoporosis, the special construct of the orthosis with prevention of movements in the hip joint was used for increasing rigidity for additional immobilization. The movements in the knee joint were free.
The immobilizer was a rigid separable polyethylene case, which was fixed with regulated clasps, and a lumbopelvic tourniquet with fixation of its upper part to pelvic wings with transition to the hip up to the knee joint. The immobilizer was equipped with the cover on the anterior surface for more proper immobilization of the hip segment. The construct of the orthosis provided the stabilization in the fracture site during vertical loads, with removal of leveraged mechanisms of displacement during walking, and active initiation of rehabilitation measures (Fig. 8b, c).

Figure 8. The patient M., age of 35. Diagnosis: a transverse and splintered fracture of the femur in the upper one-third of the right leg


The patient moved in the immobilizer with crutches, and then with the walking stick (5 weeks). The periodical control for adjacency of the orthosis was realized. At that, the use of the immobilizer considered the absence of pain and excessive pressure to soft tissues of the extremity.
One and half of a month, after recurrent surgery, the control X-ray examination showed the adequate position of the plate and fixation of the fracture site, with satisfactory condition of fragments. The patient could walk without additional supporting measures with the immobilizer. The patient resumed his professional activity after 7 weeks. 6 months after surgery, the frontal X-ray image (Fig. 8d) showed the fracture union. Orthosis therapy was completed: supporting ability recovered, joint movements were within the whole range.

In all case, the orthosis therapy system included:

- prescription of the orthosis in the beginning of medical and rehabilitation period (at admission);

- adaptation of the construct on the injured segment during installation by the orthopedist;

- selection of type of using;

- training for using the orthosis;

- estimation of efficiency of the used orthosis, if necessary, additional adaptation;

- control examination 4 weeks after discharge up to union.

The results of orthosis therapy were estimated with three-score systems.
Good outcome
(455 patients, 88.5 %) – no complications during orthosis therapy. All constructs were well tolerated. The orthoses were optimally adapted to adjacent tissues. The preliminary tasks were realized. The fractures united. The supporting ability (for the lower extremity) and other functional characteristics restored. The allowable moments were slight limitation of range of movements in intraarticular fractures, in bone tissue defects without influence on extremity function, absence of union during recovery of extremity function. The life quality and total amount of points was 80-100. Herfindahl-Hirschman index ≈ 0–1, IMR index ≈ 13–15.
Satisfactory outcome
was in 36 patients (7.1 %). This group demonstrated the skin irritation, painful pressure sores in the sites of dense adherence of the orthosis to bone prominences and soft tissues; sweating of the orthosis segment, inadequate changes in its volume during therapy. These complications caused a necessary (but temporal) refusal from the orthopedic item, its improvement or use of other construct. The complications, which were timely identified and treated, did not influence on the outcome of orthosis therapy. The patient’s activity with life quality questionnaire and the general number of points varied from 60 to 80. Herfindahl-Hirschman index (HHI) ≈ 1–2, IMR index ≈ 12–13.
Poor outcome
was in 23 patients (4.4 %). This group included the patients who discontinued the orthosis therapy according to various causes (mainly mental ones). Their common complaints were progressing pain in the fracture site or in the places of contact between elements and the bony prominences and soft tissues. These patients used other types of treatment. Despite of this, the extremity was amputated in 7 patients.
The efficiency of orthosis therapy was estimated with testing 242 patients with the most common condition: unstable osteosynthesis of the femur of tibia with migration of the fixator. All patients received the orthosis therapy with use of different constructs. The condition was controlled before completion of the treatment.

A similar study was conducted in the control group including 62 patients with similar complications, but treated with classic techniques. The patients received the plaster splint, with limitation or full prevention of axial load. Recurrent surgery was realized in case of absent stabilization of the condition. The orthopedist-traumatologists (Moscow outpatient treatment system) participated in questionnaire.

Before orthosis therapy, the indices of responses in the main group corresponded to 8 according to IMR and 6 according to HHI. After initiation of orthosis therapy, within 2-3 weeks, the patient trained to use the orthopedic system in home conditions. In this period, the construct was adapted and optimized. The mobility and walking tests showed higher mobility by the moment of week 8 after initiation of orthosis therapy – IMR – 12, HHI – 4 (Fig. 9). The X-ray examination showed some signs of bone regeneration. The control group showed the stable values for the whole period of the follow-up.

Figure 9. Dynamics of changes of Hauser Ambulation Index and Rivermead Mobility Index in orthesis therapy and treatment with plaster bandages



Orthosis therapy is the modern, efficient technique for conservative treatment of fractures of long bones and complications. At the same time, it is the new tool for earlier and active rehabilitation. Timely initiated orthosis therapy is a preventive measure for complications, including deformations. Before fracture union, it allows functional and social activation of the patient with positive influence on the process of bone tissue regeneration. 

Information on financing and conflict of interests

The study was conducted without sponsorship. The authors declare the absence of any clear or potential conflicts of interests relating to publication of this article.


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