1. INTRODUCTION

 

The rate of occurrence of high-energy trauma is increasing at a rate that is proportional to the rate at which industrialization and urbanization are advancing year over year alongside the rapid increase in traffic. Fractures of the long bones are one of the most prevalent types of injuries that might occur in such a circumstance. The tibial shaft is the location of the long bone fractures that occur most commonly.¹

Fractures of the shaft of the tibia are significant for a number of reasons, including the fact that they are both common and disputed. Because of its anatomical location, the tibia is susceptible to receiving direct blows and high-energy trauma as a result of motor vehicle accidents. This exposes the tibia to the risk of suffering compound fractures, which are frequently open and result in a significant amount of skin and soft tissue loss. In contrast to the rest of the appendicular bone, the tibia has a tenuous blood supply due to insufficient muscle protection. This makes the tibia particularly vulnerable to injury and delayed union. Fractures of the tibia are linked to an increased risk of compartment syndrome, as well as vascular and neurological injury. The fact that both the knee and the ankle have hinge joints prevents any kind of rotatory deformity from occurring following a fracture. The therapy of these fractures can be challenging at times due to the high prevalence of comorbidities that are associated with them, particularly when the fracture is open. Furthermore, the most effective form of treatment is still a contentious topic of debate.2

The surgeon should be capable of using all of the different modalities of treatment, such as conservative treated by gentle manipulation and the above knee cast with a window, open reduction and internal fixation with plates and screws, intramedullary fixation (including ender pins, intramedullary nails, and interlocking intramedullary nails), and external fixation techniques. The surgeon should also be able to weigh the advantages and disadvantages of each technique and choose the one that offers the best overall outcome.³

In order for tibia fractures to be successfully treated, there are three objectives that need to be

accomplished. The avoidance of infections, the formation of new bone, and the recovery of lost functions are the goals of surgical treatment. These objectives are dependent on one another and must be accomplished in the sequence presented above. Infection can lead to delayed union or even non-union, which in turn slows the functional rehabilitation of the affected limb. Plaster cast immobilization was historically the most popular form of treatment for tibia fractures.^4,5

In cases of more severe or localized injuries, such as displaced intra articular fractures of the knee and ankle, apply external fixator approach may be chosen as the treatment option. External fixation, which is the treatment that many traumatologists regard to be the treatment of choice, has a number of drawbacks, including bulky frames, frequent pin track infections, non-union, and malunion. Since the image intensifier made it possible to perform closed intramedullary nailing, the intra-medullary nailing procedure, regardless of whether it is locked or unlocked, has become a desirable alternative. The nail acts as a load-sharing mechanism and resists both axial and torsional forces with a high degree of rigidity. When compared to the other types of internal fixation, closed nailing causes the least amount of disruption to soft tissue, fracture hematoma, and the body’s natural process of bone healing.^6-8

2.   REVIEW OF LITERATURE

Kushwaha and Mourya (2022)^[9] analysed the functional and radiological results of tibial shaft fractures treated with intramedullary interlocking nailing. An speedier fracture union is possible using closed interlocking tibia nailing, which also results in decreased morbidity. The closed interlocking nailing technique should be considered the optimum way of therapy for diaphyseal tibial fractures due to the high union rate and the low infection rate associated with this technique.

Hari et al (2022)^[10] examined the functional outcome as well as any problems that arose as a result of primary debridement and nailing in open tibia fractures ranging from type I to type IIIA. Sixty-six point seven percent of the thirty patients who received primary nailing for open tibia fractures had outstanding results, twenty-six point seven percent had good results, and six point six percent of the patients had fair results. Ninety-three point three three percent of the patients had union within nine months, while six point six six percent of the cases experienced delayed union. It’s a wonderful treatment choice for open tibia fractures to use primary intramedullary interlocking nailing since it helps patients get back to work sooner and helps them move around more freely sooner. It promotes early fracture union and helps prevent the need for additional surgical treatments.

Maharjan et al (2021)^[11] compared the functional results of a hollow nailing to a solid nailing for the treatment of tibial shaft fractures using the Surgical Implant Generation Network (SIGN) in the United States. In cases of tibia shaft fracture, the functional outcome of conventional solid SIGN nailing is comparable to that of conventional hollow nailing. SIGN nail is useful for developing countries that have limited resources because it is provided free of charge and is designed to be used without the need for an image intensifier or fracture table.

Lu et al (2020)^[12] analysed the efficacy of a recently developed reduction device in the

treatment of tibial shaft fractures using intramedullary nailing (IMN). The device was designed to assist in the reduction of fractures of the tibial shaft. In all, 42 patients were treated with the novel reduction device (group A), while 56 patients were treated with the traditional reduction procedure (group B) (group B). When compared to group B, all of the following statistics were better for group A: the average amount of time spent operating, the quantity of blood lost, the number of fluoroscopies, and the number of surgeons were all lower. The rate of decrease in the number of closures in group A was much larger when compared to that of group B. There was no discernible difference between the two groups with regard to the length of time it took for the fracture to heal, the AOFAS score, or the percentage of patients who had complications.

Khairnar et al (2018)^[13] examined the parameters that influence deep infections and fracture healing following treatment with immediate or delayed interlocking IMN for tibial shaft fractures. According to Johner and Wruhs’ criterion, 91.67 percent of patients achieved outstanding results, 3.33 percent achieved good results, and 1.67 percent achieved bad results. The use of interlocking intramedullary nailing as a therapy for closed and grade one open fractures of the tibia shaft entails minimum surgical stress and negligible blood loss. However, this treatment offers the benefits of early ambulation, a lower infection rate, and a reduced risk of delayed union, non-union, and mal-union.

Chauhan et al (2016)^[14] studied the diaphyseal fractures and the functional outcomes of patients whose tibial shaft fractures were treated with an intramedullary interlocking tibial nail were evaluated. The advantages of tibial intramedullary interlocking nailing include the preservation of periosteal blood flow, the maintenance of length, rotation, and alignment, and a reduction in the risk of infection and malunion. For the treatment of tibial diaphyseal fractures, the conventional surgical approach consists of closed internal fixation with intramedullary interlocking tibial nail placement. It is possible to begin ambulation without

using external immobilization at an earlier stage, which not only shortens the patient’s time in the hospital but also allows him to resume his work activities sooner as he is able.

Karaarslan et al (2016)^[15] evaluated the clinical outcomes of treating tibial shaft fractures with standard intramedullary interlocking nails versus intramedullary nails crushed by proximal tubes. In the group of patients who were treated with proximal compression tube nails, all of the fractures were successfully joined with no extra surgical intervention required with the exception of one. On the other hand, in the group of patients who were treated with traditional interlocking nails, there were three incidences of nonunion and six patients who needed dynamization surgery (p = 0.005). In the treatment of transverse and oblique tibial shaft fractures, the proximal compression tube nail system is preferred over traditional techniques of nailing due to its superior compression capabilities. This is because, in comparison to traditional nailing procedures, the proximal compression tube nail system has a decreased incidence of nonunion, proximal locking screw failure, and proximal nail migration. In addition to that, the amount of time required for this system to recover is much smaller.

Farooq et al (2015)^[16] determined the percentage of successful treatment with reamed interlocking nail for tibial diaphyseal fracture. According to the findings of this study, 83.08 percent of the comments were classified as Excellent, while just 16.92 percent of the responses were rated as good. The findings of this study indicate that the use of reamed interlocking nail in the treatment of tibial diaphyseal fracture may be effective, and it may be suggested as a method of stable fixation that allows for an early return to work. The findings of this study suggest that the use of reamed interlocking nail in the treatment of tibial diaphyseal fracture may be effective.

3.  AIM & OBJECTIVES:

 

3.a  AIM

 

Functional outcome of tibial shaft fractures treated by Intramedullary Interlocking nail.

 

3.b  OBJECTIVES:

 

 

1. To investigate the functional outcomes among patients that underwent intramedullary interlocking nailing for their tibial shaft fractures.

2. To determine whether or not patients who were treated using this method attained consistent union and to determine when such patients went back to work.

To record both the significant problems (prevalence of malunion) and complications.

 

 

 

.

4.MATERIAL AND METHODS

 

The present prospective clinical study included 100 patient who aged 16 years to 70 years admitted to the Department of Orthopaedics, Varun Arjun Medical College & Rohilkhand Hospital, Lucknow road, Banthra Shahjahanpur Uttar Pradesh, India.

Study Period- 2022-2025

 

    Study Population- Patient admitted with traumatic fractures

 

Sample Size: 50 Patients

 

Selection of Patients- All patients fulfilling inclusion criteria

 

.

 

4.a STUDY DESIGN

 

This study is a prospective observational study.

 

4.b SELECTION OF STUDY POPULATION

 

Subjects will be selected from admitted cases from outpatient and emergency department of Orthopaedics at Varun Arjun Medical College and Rohilkhand Hospital based on inclusion and exclusion criteria.

4.c INCLUSION CRITERIA

 

•                Age >16 years to 70 years

 

•                Closed and Gustilo grade I fractures

 

•                Presenting within two weeks of injury

 

•                Traumatic fractures

 

.

4.d EXCLUSION CRITERIA.

 

1.             Fracture within 5 cms from proximal to ankle joint distal to tibial plateau

 

2.              Deformed medullary canal or abnormally bowed tibia

 

3.             Multiple injuries/polytrauma

 

4.              Compromised soft tissue

 

 

4.e SAMPLE SIZE ESTIMATION

 

The minimal number of patients that should be included in the  research, according to the calculations was 100.

 

4.f STUDY DURATION

 

The study will be carried out from the period of January 2023 to October 2025.

 

4.g Study procedure

 

Detailed examination of patients like demographic, clinical, radiological and biochemical data will be taken as per the prescribed proforma.

 

•   FUNCTIONAL SCORES (CLINICAL ASSESSMENT):

 

The functional outcome will be calculated using a standard set of questions. We used the AOFAS and Olerud and Molander scores.

 

 

AOFAS:

 

There are nine questions total, and they are broken up into three categories.

 

1.     Pain

 

2.     Function

 

3.     Alignment

 

The maximum number of points that could be awarded to a patient was 100.

 

OLERUD AND MOLANDER SCORE:

 

This is a questionnaire that is completed by the patient themselves. The lowest possible score was zero, which denoted full incapacity, and the highest possible score was one hundred (completely normal). It is composed of nine distinct facets altogether.

1. Pain 2. Stiffness   3. Swelling   4. Stair climbing   5. Running    6. Jumping     7. Squatting

 

8. Supports   9. Work

 

Score	Grade
91-100	Excellent
61-90	Good
31-60	Fair
0-30	Poor

 

 

RADIOLOGICAL ASSESSMENT:

 

The radiographic evaluation looked at many different things, including malaignment, the length of time it took for the bones to union, and the amount of reduction that was lost. Following the completion of the radiography examination, the anteroposterior and lateral pictures of the affected limb were analysed and contrasted with one another. This checkup included both the knee and the ankle joints for a complete assessment. For the purpose of computing the varus and valgus angles, the Paley and Tetsworth method was used.

The diagnostic criteria that should be employed for radiological assessment of shaft tibia fractures are as follows: consistent bony union, malunion, non-union, and delayed union are all included in this definition.

Diagnostic criteria:

 

Shaft tibia fractures: A fracture of the shaft one-third of the tibia can be seen four centimeters to

eleven centimeters above the tibial plafond.

 

Consistent bony union: As a basis for its definition, Sarmiento proposed two criteria, and they served as the definition’s foundation.

1.     The patient’s capacity to support their own weight without experiencing any discomfort

 

2.     On three of the four cortices that go over the fracture, visible bridging callus may be seen on the AP and lateral radiographs.

 

 

Malunion: Malunion defined as

 

1.           Deformity in the varus or valgus plane that is more than 5 degrees

 

2.           A greater than ten-degree angle between the anterior and posterior views.

 

3.           A diminution in the length of the limb of more than one centimeter.

 

 

Delayed union: Failure of the fracture to unite within six months after surgical treatment the definition of delayed union.

 

 

Non-union: Failure of the fracture to unite within nine months following treatment regarded as non-union.

 

 

SURGICAL TECHNIQUE:

 

Depending on the complexity of the procedure, a postgraduate registrar, a junior consultant, or a senior surgeon can be the one to do it. In every single one of these operations, the patient was required to lie supine during the procedure. After applying betadine paint to the injured limb and wrapping it in a way that would allow it to be left hanging freely from the side of the operating table after the treatment was over, the leg was left in this position. It was necessary that the knee be able to bend properly in order to successfully perform central insertion of the guide wire without damaging the posterior cortex. This was only possible if the knee was able to flex. This was confirmed by carrying out a variety of tests. Concurrent fibula fixation was carried out on nine of the patients as part of the procedure. It was totally up to the judgment of the operating surgeon to decide whether or not the fibula should be repaired before or after the tibia was nailed. Either the fracture needed to be aligned, the patient required proper length, or the patient needed more stability; hence, the fibula needed to be corrected. Because the patient needed more stability, the patient needed proper length. After it was decided that the fibula should be treated first, a lateral incision was performed to expose the fracture in the bone of the lower leg.

After the fibula fracture was reduced and stabilised using 1/3 rd tubular plates or 3.5mm DCP, the leg was propped up against the side of the table while the tibial nailing procedure was carried out. An incision in the skin of five centimetres was made, beginning at the tip of the tibial tuberosity and extending proximally to the lower pole of the patella. This incision was made. In each and every one of these cases, the approach of repairing the patellar tendon was implemented. An entrance site was established with an awl directly below the articular border of the tibial plateau in lateral view and medial to the lateral tibial spine in anteroposterior view. This was done after it was determined using an image intensifier that there was no rotational malalignment of the tibia. After it was confirmed that there was no rotational malalignment of the tibia, this procedure was carried out. After a guide wire was placed, the fracture was manually reduced. Afterwards, the guide wire was removed.

Implants used:

 

Intra Medullary Inter Locking Tibia Nailing.

    5.   ETHICAL COMMITTEE CLEARANCE

 

 Institutional ethical committee clearance will be taken before the start of the study.

 

6.     STATISTICAL ANALYSIS

Statistical analysis was used to look for significant links between the many variables that were being researched and the data that had been gathered. The version 25.0 of SPSS was used to conduct the analysis. When presenting descriptive statistics for categorical variables, frequencies and percentages were employed. When presenting descriptive statistics for continuous variables, the mean and standard deviation were used. The unpaired sample T-test was used so that a comparison could be made between the bivariate samples that were taken from the two separate groups (male and female). The Chi-square test was used in order to determine the relevance of the category data. The significance level of the probability value

0.05is judged to be met by each of the statistical techniques described above

 

 

 

7.     SOURCES OF FUNDING

 

This research did not receive any specific grant from funding agencies in thepublic, commercial, or not for profit sector.

 

8.     CONFLICT OF INTEREST

 

None of the investigators or participants has any conflict of interest of any kind whatsoever with the research and its outcome.

PATIENT PROFORMA SHEET

 

Name:                                                                                         CR no:

 

Age:                                                                                             Gender:

 

Address:                                                                                     Occupation:

 

 

Diagnosis-

 

 

 

Chief complains:

 

Medical:                                             Surgical:

 

 

IMPRESSION:

……………………………………………………………………………….

……………………………………………………………………………….

 

 

TYPE OF PROCEDURE:

………………………………………………………………………………..

………………………………………………………………………………… FOLLOW UP:

 

 

 

Post - Operative evaluation

                                                   VARUN ARJUN MEDICAL COLLEGE &                 

                                                              ROHILKHAND HOSPITAL

 

Lucknow Rd, District Shahjahanpur, Banthara, Uttar Pradesh 242307

Patient Information Sheet (English)

Study title: “FUNCTIONAL OUTCOME OF TIBIAL SHAFT FRACTURESTREATED BY INTRAMEDULLARY INTERLOCKING NAIL”

 

Read the following instructions carefully. You can query the investigator about the study at any time during the study.

1.     Willingness for the study: Your willingness will be taken before the start of the study.

 

You can decline to take part in the study. You can withdraw yourself from the study at any point in time without giving any reason. Appropriate and adequate treatment would still be provided to you. If you think that any question is inappropriate or not applicable to you, you can deny answering such a question.

2.     Purpose of study: Your contribution to this study will help us to analyze and interpret the study results. This will help in the treatment of other patients with similar complaints.

3.     Subject Selection: You will be included in the study if you fulfill the following criteria:

 

·       Patients admitted and willing for the procedure.

 

·       Patients will be enrolled ranging from 16 years to 70 years.

 

4.     Study Description: At the time of enrolment relevant investigations will be done. You will be asked questions related to the study. You will be given standard treatment for your