Introduction

Fractures of the distal tibia are a difficult treatment problem due to the specific anatomy of this area and the soft tissue injuries resulting from trauma. A fracture of the distal tibia is considered to be a fracture located 10 cm above the ankle joint line [1]. A definition that more broadly reflects this problem was given by Heim, who defined it as damage primarily to the soft tissues around the ankle joint coexisting with a fracture of the distal tibia, where the damaged bone fragment is widest [2]. The goal of surgical treatment is the anatomical reduction of the fragments and stable fixation enabling rapid post-operative rehabilitation, especially of the ankle joint. The surgery itself should not cause additional deterioration of the surrounding soft tissues.
Open reduction and fixation using a LCP (Locking Compression Plate) is a commonly used method of treatment, but the high rate of complications, such as post-operative wound dehiscence, skin necrosis and infections, cause that a minimally invasive osteosynthesis method is sought. A certain solution to the problem is the use of the MIPO (Minimally Invasive Plate Osteosynthesis) technique, however, the frequency of complications using this technique is four times higher than the number of complications after intramedullary fixation [3,4].
Against the background of the methods presented above and the problems associated with their use, intramedullary fixation seems to be the best alternative. However, an increased risk of non-anatomical repositioning and its loss during the fracture healing process are described [5,6]. From the point of view of biomechanics, the distal fragment is short, has a wide marrow cavity, and the asymmetric muscle forces acting on it can cause secondary displacement despite initially correct repositioning with an intramedullary nail.
Krettek and Stedfeldt presented the solution to the problem of instability of the intramedullary fixation of fractures of the distal tibia by the additional use of Poller screws and TMS screws [7,8,9]. Based on their clinical experience and research conducted on models [9], they indicated the number and location of these screws, however, without taking into account the type of fracture of the distal tibia. It was not until 2011 that Goldzak presented his own project of dividing fractures of the distal tibia together with the algorithm of the surgical procedure in which he precisely specified the place of insertion and the number of TMS screws, as well as indications for the possible fibula fixation [10]. In 2019 he was published a paper, describing in detail the use of TMS screws based on a new biomechanical classification of fractures of the distal tibia and the initial results of treatment [11].

Assumptions and aim of the study

The assumption of the study is to demonstrate the effectiveness of the use of an intramedullary nail in combination with TMS screws and to assess the practical usefulness of the Goldzak classification in the treatment of fractures of the distal tibia.
The aim of the study is to evaluate the results of surgical treatment of fractures of the distal tibia using intramedullary nails and directional screws, in particular to assess the bone fragment repositioning and the time of bone union, as well as to assess the function of the upper ankle joint after treatment. The comparative study referred to the ankle joint of the patient’s other limb.

Materials and methods

In the department of first author, 54 surgeries were performed in the period from January 2014 to December 2018 due to a fracture of the distal tibia according to Goldzak classification. Patients with open fractures (7) and multi-organ injuries (3) were excluded from further studies. Four patients, after initially expressing consent to participate in the study, did not cooperate at various stages and were not taken into account in the development of the results. Patients who did not have complete X-ray documentation were excluded from the study. A total of 14 patients were excluded. Finally, the study group consisted of 40 patients (24 men and 16 women) treated surgically for a fracture of the distal tibia with the use of an intramedullary nail and TMS screws. The average age of the study participants was 48 (25-76). The follow-up period ranged from 6 to 48 months after injury, with an average of 25.3 months. The study was retrospective.
Inclusion criteria:
Follow-up time from 6 to 48 months after injury.
Isolated fracture of the distal tibia.
Surgical treatment using an intramedullary nail and TMS screws according to Goldzak classification.
No systemic diseases that could affect the healing process and the final result of fracture treatment.
Uniform program of post-operative rehabilitation.
The patient’s healthy ankle joint was examined for comparison.
Exclusion criteria:
Open fractures of the tibia.
2. Patients under 18 years of age.
3. Patients after multi-organ trauma.
4. Systemic diseases that may affect the healing process and the final result of fracture treatment, e.g. atherosclerosis obliterans, diabetic foot.
5. Pathological fractures.

All patients were subject to interviews, physical examinations and X-rays. The interviews included the patient’s age and sex, occupation, analysis of previous medical history, e.g. exclusion of fractures in the tibia in the past, the presence of diseases that may affect the post-operative outcome, such as smoking, and the exclusion of systemic diseases. In addition, the mechanism of injury, method of treatment, nature of pain and its location after treatment, as well as the occurrence of complications after surgical treatment of fractures of the distal tibia with the use of an intramedullary nail and TMS screws were assessed.
Fractures were classified according to Goldzak [11]. This classification is based on X-rays in the AP projection. It divides fractures within the distal tibia into 3 types depending on the course of the fracture fissure and 2 subtypes: A and B. Subtype A – without a fibula fracture or with a fibula fracture above a tibia fracture. Subtype B – a fibula fracture at or below a tibia fracture. In this classification, the author also provides guidelines regarding the location of TMS screws and the need to perform sagittal fixation (Fig. 1) [11]. All patients were operated on according to the algorithm presented by Goldzak by a total of 7 specialists and residents in the field of orthopaedics and traumatology of the locomotor system employed in the department. Surgery was performed using a Targon T cannulated intramedullary nail (BBraun Aesculap) and TMS screws 4.5 mm in diameter from the set by the same company. An example of a pre- and post-operative X-ray is presented in (Fig. 2).
The type of fracture was assessed on the X-rays according to Goldzak classification (distribution of fracture types as in Table 1). In addition, the correct location of the directional screws, the correctness of fibula fixation, the quality of repositioning of tibial bone fragments based on post-operative X-rays in AP and lateral projections, as well as LDTA (lateral distal tibial angle) and ADTA (anterior distal tibial angle) angles were assessed [12]. Fracture reduction was correct if the angular deviation, valgus/varus did not exceed 5°, and the anterior-posterior flexion did not exceed 10° [13].
The maintenance of tibial reduction was also assessed on the basis of X-rays in AP and lateral projections made after obtaining bone union. Osteosynthesis errors were also assessed.
Post-operative rehabilitation was carried out according to a fixed, uniform program: the limb was not immobilized in the post-operative period, on the first day after surgery the patient started walking with the aid of elbow crutches with partial load on the operated limb. Active knee and ankle exercises were performed from the first day. From the 6th week after surgery, passive and active-passive exercises were used to increase the range of motion in the ankle joint. After obtaining bone union (in most cases after 3 months), full load of the operated limb and walking without the help of were allowed. The function of the operated and unoperated limbs of patients from particular groups according to the type of fractures was assessed using standardized questionnaires, including AOFAS – The American Orthopaedic Foot and Ankle Score, VAS – Visual Analog Scale, and the SF36 – Short Form Health Survey – quality of life questionnaire.
The results were statistically analysed using the SPSS Statistics program (version 27.0.1.0). The study presents basic descriptive statistics.
The red dot marks the insertion point of the TMS screw. This figure has been used with the consent of the co-authors of the publication [11]

Results

Clinical examination
The result of Fisher’s exact test (p < 0.001) indicated that the proportion of limbs with widened and not widened outlines of the ankle joint differed significantly depending on whether the limb was injured or not.
Significant differences between the injured and uninjured limbs were observed in all elements of the range of motion of the upper ankle joint, i.e. dorsiflexion (p < 0.001; Z = -5.4), plantar flexion (p < 0.001; Z = -4.6), pronation (p < 0.001 ; Z = -4.9) and supination (p < 0.001; Z = -4.8).
There was no statistically significant difference between the injured and uninjured limb in terms of knee joint mobility (p = 0.194).
The mean AOFAS score in the study group was 91.5 points (SDAOFAS = 8.4). The majority of patients (35%) had the maximum AOFAS score. The patient with the lowest AOFAS score obtained 68 points.
The average VAS score in the analysed sample was 2.2 points, which indicates the perception of mild pain. Patients with different types of fractures according to Goldzak classification did not differ significantly in the results obtained in the AOFAS scale (p = 0.133) – no differences in the assessment of ankle joint function were observed.
The result of the Kruskal-Wallis test shows no significant differences in the assessment of pain in patients with particular types of fractures according to Goldzak (p = 0.398). The results of the clinical examination and the AOFA, VAS and SF-36 forms are presented in Tables 2 and 3.

X-ray
Bone union was achieved in all patients. In 80% of patients, bone union was achieved in less than 6 months. In the remaining patients, bone union was achieved within 6 months after surgery, except for one, in whom union was observed after 12 months.
Taking into account the type of fracture it should be noted that in all patients with fractures 1A and 2A union was achieved in less than 6 months. The highest percentage of patients with union time of at least 6 months was observed in fractures 2B (60.0%) and 3B (42.9%), respectively. The X-ray results are presented in Table 4.

Discussion

The use of intramedullary nails in the treatment of long bone fractures is considered the gold standard, and the results obtained are described as good and very good
[14-18].
An important step in the development of the surgical technique using intramedullary nails and TMS screws was research conducted by French orthopaedist Mario Goldzak. As a result, he proposed a new, separate classification of fractures of the distal tibia [11]. In this classification, taking into account the type of fracture, he precisely indicated the place of insertion of TMS screws and the need to perform or abandon fibula fixation. Subsequently, Goldzak, together with Biber and Falis, published a preliminary assessment of the results of patients treated in this way and confirmed the high clinical usefulness of the method. They analysed 67 patients with a fracture of the distal tibia treated with intramedullary nails and TMS screws based on Goldzak classification of fractures. Bone union was achieved in all patients. The functional assessment was based on the Olerud/Molander scale, with an average score of 85 points [11].
We confronted the results of the patients we treated with the results obtained by Goldzak as the creator of the classification and with the results of authors using other methods of surgical treatment.
All patients treated by us using intramedullary nails and TMS screws achieved bone union. In 80% of them union was achieved in less than 6 months. Among this group, 25% of patients achieved union after 6 weeks, while in 55% – after 3 months. In the remaining patients union was achieved within 6-12 months after surgery. Only 1 delayed union was observed, which was achieved 12 months after surgery. Zou achieved union in patients treated with the ORIF method in 90.5% of cases, and in patients treated with the MIPPO method in 98.1% of cases [19].
Based on a meta-analysis of 1,332 patients with fractures of the distal tibia treated with intramedullary nails, Bleeker observed a mean union time of 4.2 months compared to 4.5 months after fixation using a plate [20].
Saglam achieved union after treatment with the IMN method after an average of 4.4 months [21]; comparing the time of union between patients treated with IMN vs. MIPO in both groups, Kang achieved union after an average of 3 months [22], and Vidovic achieved union in patients treated with the MIPPO method after an average of 4.9 months [23], while Eken reports an average union time for MIPPO treatment of 4.23 months [24], and Marroquin-Herrera after fixation using an LCP plate achieved union in 37.5% of cases after 6 weeks, in 40 % of cases after 3 months, in 22.5% of cases after 6 months [25].
Compared to the presented literature, we obtained a better result with an average time of bone union of 3.5 months.
The analysis of X-rays consisted in assessing the repositioning of the fragments by calculating ADTA and LDTA angles on the post-operative X-ray and after achieving bone union. The result of the analysis showed that the mean LDTA angle after surgery differs statistically from the assumed standard of 90°- it is lower. In the study there were no significant differences between the mean ADTA angle after surgery, and the assumed standard (85°).
There was no statistically significant difference in the LDTA angle after surgery and after union . The difference after surgery and after union was also not observed in the case of the ADTA angle.
The obtained results prove the stability of the intramedullary nail/TMS screw structure and the lack of secondary displacement of bone fragments during bone union and loading of the limb by the patient.
The parameter that we analysed in our patients was the range of motion of the ankle joint due to the fracture located in this area. The results of the examination of the range of motion of the upper ankle joint indicate the presence of limitations in all examined directions. The greatest deficit was noted in dorsiflexion, followed by supination. The patients operated on by us achieved, respectively: the average angle of dorsiflexion 16 degrees, the average angle of plantar flexion 35 degrees, the average angle of pronation 42 degrees, the average angle of supination 20 degrees. In the analysed literature, Vidovic gives the average range of dorsiflexion after MIPO (Minimally Invasive Plate Osteosynthesis) treatment of 10 degrees, and of plantar flexion of 28.3 degrees [23], which is a worse result than ours.
Statistical analysis also showed significant differences in all elements of the range of motion of the upper ankle joint between the injured and uninjured limb. Worse mobility of the ankle joint after a fracture of the distal tibia and after the applied surgical treatment is undoubtedly caused by the proximity of the fracture fissure. Another factor that may affect the final clinical effect is poor blood supply within 1/3 of the distal tibia, additionally damaged during the injury. Post-operative pain and swelling of soft tissues characteristic of injuries in this area also hinder rehabilitation in the first weeks after surgery. Analysing the results obtained by us, it is worth recommending a more intensive post-operative rehabilitation program in order to obtain better results of ankle joint mobility.
When evaluating the function of the ankle joint of the injured limb after surgery, the AOFAS score was 91.5 points, which was a very good result. In literature, Rubio-Yanchuck, after ORIF treatment of fractures of the distal tibia, obtained an average AOFAS score of 84 points [26], Viberg – 73 points [27], Van den Berg – 84 points [28], and Vicenti – 84.96 points in patients treated with the MIPPO method [29].
Comparing the functional results between patients treated with the IMN vs. MIPO method, Kang obtained the results of 46.92 vs. 46.89 in the JLETS scale [30], while Dong-Il Chun, making a similar comparison between IMN vs. Locking Plate, obtained the results of 81.1 vs. 87.3 in the AOFAS scale [31].
Mobility of the knee joint and the possibility of the impact of the fracture and the surgical technique used on this joint were also assessed. We did not record any limitation of mobility in the knee joint of the injured or uninjured limb.
Evaluating 81 patients treated for fractures of the distal tibia using the SF-36 form, Rubio-Yanchuck obtained an average score of 51.9 points in the physical sphere and 47.3 points in the mental sphere [26], while Van den Berg published the results of the SF-36 questionnaire in his paper: 78.1 points in the physical sphere and 78.6 points in the mental sphere [28]. The presented results are worse than those obtained by us (Table 3). Evaluating 116 patients with a fracture of the distal tibia, in his study Van den Berg confirmed the negative impact of this type of injury on the quality of life, as more than 2/3 of the patients suffer from chronic pain [28].
An important element of the study was the assessment of pain in operated patients. Pain is subjective: it is what the patient feels regardless of the symptoms associated with it [32]. There are several tools to help assess pain intensity. In the study, we used a numerical scale and assessed pain according to the VAS scale and the SF-36 questionnaire.
The analysis of the VAS results showed an average pain perception in the injured limb at 2.2 points, which indicates the perception of mild pain.
The analysis of the results according to the SF-36 questionnaire showed an average score of 88.3 points, which, similarly to the analysis of the VAS scale, indicates the perception of mild pain.
In her study, Vallier described the occurrence of chronic pain in the ankle area in 40% of patients with a fracture of the distal tibia operated with the IMN method, and in 32% of patients in whom an LCP plate was used [33].
The obtained results and literature analysis allow us to conclude that none of the methods of surgical treatment of fractures of the distal tibia can eliminate pain completely.
An inseparable element related to surgical treatment is the possibility of complications. Among 40 patients treated by us with a fracture of the distal tibia using the IMN + TMS method, in one case (2.5%) delayed union was observed – i.e. 12 months after surgery. This patient required an additional procedure – dynamization of intramedullary fixation involving the removal of two proximal locking bolts. In two cases (5%), the post-operative X-ray showed the placement of the TMS screw that was inconsistent with Goldzak classification. These were fractures classified as 2B and 3B according to Goldzak, which are classified as the most complicated. Undoubtedly, they could have made it difficult to interpret the course of the fracture fissure, and could have caused a wrong classification, and thus the placement of the TMS screw in an incorrect position. In both patients with the TMS screw on the wrong side, union time was long – 6 and 12 months. In two cases (5%), a complication in the form of prolonged wound healing with local superficial infection in the area of distal locking bolts occurred after surgery. In both cases, the wound was healed after the administration of antibiotics. In four cases (10%), unsatisfactory repositioning of the fragments was observed, with the setting of the distal fragment to valgus/varus above 5 degrees. No complications in the form of deep infection or destabilization of the fixation were observed. As it is well known, the treatment of deep infections is difficult and has a high failure rate. Babiak achieved healing of an infected tibia fracture after treatment with a cemented nail in 67% of cases (4 out of 6 cases) [34].
Borens et al. presented the results of treatment of fractures of the distal tibia using the MIPO technique and achieved union in all cases, very good results and satisfactory results in 88% of cases. Unfortunately, the rate of infectious complications was still high [3].
Comparing the methods used in the treatment of fractures of the distal tibia, it can be concluded that fixation using intramedullary nails with the use of TMS screws allows for the achievement of very good and good results in individual assessment scales. A relatively simple surgical technique combined with the repeatability determined by Goldzak classification ensures the union of fragments in the correct position without significant restrictions of mobility in the adjacent joints. At the same time, the number of problems and complications is relatively low and compares favourably with other surgical techniques.

Conclusion

The function of the ankle joint after surgical treatment of a fracture of the distal tibia with an intramedullary nail and TMS screws in the AOFAS scale corresponds to a very good assessment, and in the VAS scale it corresponds to mild pain.
Fixation of the tibia with an intramedullary nail and TMS screws allows for anatomical repositioning of bone fragments and maintaining it until bone union is achieved.
Bone union after surgical treatment of fractures of the distal tibia with the use of an intramedullary nail and TMS screws was achieved in most cases in less than 6 months.

The study was conducted after obtaining the consent of the Bioethics Committee of the Medical Centre for Postgraduate Education of the Medical University of Lodz RNN/235/19/KE of May 14, 2019.
Informed consent to participate in the study was obtained from the patients.

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