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Study on functional outcome of primary closed nailing in compound diaphyseal fractures of tibia

Introduction: Open fractures of the tibia are among the most common of serious skeletal injuries, can cause permanent sequelae if not managed timely and precisely. Material and Methods: The study group comprised of 30 patients who underwent closed locked intramedullary nailing. Follow up done for period of one year from July 2019 to June 2020 in prospective and retrospective manner at Department of Orthopaedics, Rajah Muthiah Medical College, Annamalai University. Results: The Mean time of union was found to be 14 weeks 4 days for all compound fractures, for grade I compound – 13 weeks 3 days, for grade II cases – 15 weeks, and for grade IIIA cases – 17 weeks 1 day. Based on Johner-Wruhs criteria 90% and 10% of grade I cases had excellent and good outcome. 80% and 20 % of grade II cases had excellent and good outcome. 75% and 25% of grade IIIA patient had excellent and good outcome. Overall 83.3% of compound fracture had excellent outcome and 16.7% of compound fractures had good outcome respectively. Complication encountered was superficial infection (6.6%) in 2 patients, 3 (10%) patients had anterior knee pain, non union in 2 patients and delayed union in 1 patient. Conclusion: our study concluded that in Grade I, II and Grade IIIa tibial diaphyseal fracture, treated with closed intramedullary interlocked nail had excellent to good functional outcome with proper alignment, good range of motion, low infection rate and less patient morbidity.


Introduction
Tibia fractures are the commonest long bone fractures, most commonly resulting from high velocity injury. There has been an exponential increase in vehicles in India in the last decade, which has ultimately become the most common cause for high velocity injury. Tibia being a superficial bone has become vulnerable for such injuries. Injuries occurring here are classified based on soft tissue injury as open or closed [1] .  Open tibial fractures are often associated with severe soft tissue and bone injury [2] .  The management of open fractures is regarded as an orthopaedic emergency [3] .  The primary objective in managing an open fracture is union with prevention or eradication of wound sepsis [4] .  In orthopaedic traumatology, the method of soft tissue stabilization and skeletal stabilization are still debated [5] .  Intramedullary nailing in open fractures of the tibia is a well-accepted treatment modality in the developing world. References are scanty regarding the incidence of infection or nonunion related to specific type of open injury with this background [6] .  In this study we investigated whether primary nailing in compound tibia fractures were producing satisfactory outcomes and we compared the outcomes in terms of fracture union and rates of infection.

Wound management and antibiotic prophylaxis
In the emergency department patients were given a stat dose of tetanus toxoid and a thirdgeneration cephalosporin, aminoglycosides, metrogyl (after test dose). Wounds were cleaned, irrigated and dressed, and the limb splinted prior to urgent surgical debridement. Debridement done and after observation for 24 to 36 hrs with varies of each patients, stabilisation with a locked intramedullary nail was performed based on wound status for open tibial fractures. The transpatellar tendon approach was used under guidance of an image intensifier. The injury was classified intra-operatively according to Gustilo and Anderson. The decision to ream the intramedullary canal was undertaken by the operating surgeon. Distal fragment reaming was not done for all grade IIIA cases during intra operatively Wounds were opened wash given edges trimmed, wound covered with oppsite primary nailing done then after wound appoximated with 2.0 ethylon interrupted sutures. Most current guidelines recommend that débridement be performed within 6 hours of injury [23] . Although the details and methods of irrigation are debated, the role of careful and complete débridement is clear. Gustilo stated that adequate débridement is the single most important factor in the attainment of a good result in the treatment of an open fracture [26] . Systematic débridement, beginning with removal of gross contamination and debris, should be done as soon as possible in the casualty room. All necrotic tissue is excised, and muscle viability is determined by the four Cs: contractility, color, consistency, and capacity to bleed [26] . Completely free, large cortical bone fragments may be preserved in a sterile fashion to aid in determining length and rotation at the time of fracture stabilization. However, these fragments should be removed before definitive fixation and closure. Significant articular fragments should be thoroughly cleansed and retained when possible. In high-energy injuries, it is often difficult to fully determine the viability of all tissues within the zone of injury at the time of initial débridement. Repeat débridement at 48-to 72-hour intervals should be done to eliminate devitalized tissue that subsequently develops. Irrigation is used to supplement systematic and thorough débridement in removing foreign material and decreasing bacterial load. Based on the widespread availability of 3-L bags of normal saline, Anglen [27] recommended using 3 L of irrigation for type I fracture, 6 L for type II fracture, and 9 L for type III fracture.
Antibiotic Prophylaxis: Antibiotic prophylaxis should be initiated as soon as possible after injury. The benefit of early antibiotic prophylaxis was demonstrated by Patzakis and Wilkins, 8 who showed a significantly increased rate of infection in fractures managed with antibiotic prophylaxis >3 hours after injury compared with <3 hours after injury (7.4% versus 4.7%, respectively). However, the appropriate duration of antibiotic prophylaxis is less clear. Coagulase positive Staphylococcus aureus and β-hemolytic streptococci were the most common pathogens isolated. Open tibia fracture was the most common fracture associated with this pathogen. This study established strong evidence for the efficacy of thirdgeneration cephalosporins in the management of open fractures. Quinolones have been used as an alternative to intravenous cephalosporins for infection prophylaxis [20] . This class of drugs is attractive for several reasons. These drugs offer broad-spectrum bactericidal coverage, they can be administered orally also. They require less frequent administration, they achieve good bone penetration, and can provide prophylaxis for patients who are allergic to penicillin. Pre-operative planning: A written, informed consent was taken from all the patients for their inclusion in this study. All the patients were explained in detail the available methods of treatment, with the final treatment decision left to the patient. A detailed history was taken, ascertaining the mode of injury, with particular emphasis placed on ruling out injuries to other areas. AP and lateral views of the involved leg with knee joint were taken. Routine blood and radiological investigations were done, as required for anaesthetic clearance.

Methods
The study group comprised of 30 patients who underwent closed locked intramedullary nailing.

Operative procedures
Operative Procedure positioning of the Patient All patients are operated under spinal/epidural anaesthesia. Under tourniquet control Patient is operated with his knee flexed to 70 degrees on a bolster for entry and by leg hanging reaming and nail insertion made. Assistant forearm is used to support the distal femur at a sufficient distance from the popliteal artery and vein, if it is not properly positioned, circulation is inhibited by the force used to insert the nail and damages the vascular wall. The injured leg is scrubbed, painted with betadine, spirit and draped. Longitudinal incision over the patellar ligament at the level of joint, 5 to 6 cm long is used, splitting the tendon longitudinally. Entry portal is made in saggital plane in line with medial slope of lateral tibial eminence, in coronal plane just anterior to anterior tibial articular surface. A curved awl is used to open the medullary canal and is pushed as far as possible into the medullary canal, while the handle should be in line with the axis of the shaft. 3.2 mm guide wire is pushed into the canal, past the fracture site into the malleolar region (0.5 to 1 cm proximal to ankle joint) assisted by reduction manually. Next step is to ream the medullary canal. Reaming is done with the help of solid reamers. Normally we start from 8 mm and increase by increments of 0.5 mm. The medullary canal is reamed 1 mm more than the diameter of measured at isthmus an X-ray lateral view. Determination of the length of nail is done preoperavtively and introperatively another nail of same size, which is used with C-arm assistance. The nail with the proximal insertion handle and jig is passed over the guide wire and is inserted as far as possible, measured hammering is done to drive the tip of nail to the distal metaphysis and proximal end should be flush with the surface of cortex at the point of insertion. The nail should be centralized as far as possible, the guide wire is removed. For distal locking done using jig and checked by C-arm. Drill bit is inserted through the skin incision down to the bone near the locking holes and drilled under C-arm with axis of drill centered on the locking hole with a 4.0 mm drill bit. Drilling hole is done through both cortices, across locking holes. The length is determined with a depth gauge and confirmed with the C-arm. The distal locking is done. Proximal locking is done with proximal jig and insertion handle. Stab-incision is done over appropriate locking hole. A 8 mm protection sleeve is inserted and trocar through it, till the cortex is contacted. Trocar is removed and 4.5mm diameter drill sleeve is inserted and drilled with 4 mm drill bit. The drill sleeve is removed, depth of hole is measured with a depth gauge and a screw/ bolt is inserted which is confirmed with the C-arm. The C-arm is used to confirm the locking and nail position and fracture alignment. The wound is closed and dressing is done, compression crepe bandage is applied to control postoperative swelling. Postoperatively the limb is elevated on a pillow The Postoperative Healing Rates in Patients with Fracture. All the four studies reported the effect of primary nailing for compound diaphyseal fractures of tibia. All four analysis was made between the groups and we observed almost similar time period for the fracture to unite. Delay in union was correlating directly with the grade of injury in each reference. Some of these patients underwent secondary procedure as dynamization, for improved fracture union for certain patients.

The Postoperative Infection
All the four studies reported infection, more evident in Grade III compound fractures. All superficial and deep wound infections were identified differentiated and managed accordingly. Fractures failing to show any clinical or roentgenographic evidence of healing by 3 months after injury were considered to have delayed union. The complications (infection, delayed union, and secondary surgeries) encountered in each study group are listed in Table 2.

Results
In our study 30 patients of Grade I, II and IIIA open fracture of tibia were followed in prospective and retrospective manner. Average age for fracture shaft tibia was 40.33 years. Vehicular accident in 30 (n=30) patients was observed to be the main cause of fracture in the study and more common in males 80%. Grade II injury 43.3% (n=13) was found to be more common than grade I (36.6%) and IIIA (20.1%).
In the study mean time injury surgery interval was found to be 42.4 hours (Table-2). Majority of patients operated by tibial interlocking nail were started with partial weight bearing within 4 weeks and full weight bearing as tolerated by patient. Maximum patient were able to bear full weight between 6 to 8 weeks with mean (±S.D) of weeks. The union of the fracture was assessed by standard radiological and clinical criteria. Due to presence of nail we could not give stress to the fracture site, hence loss of pain on walking was considered as clinical indicator of union. Mean time of union rate was found to be 14 weeks 2 days. based on johner-wruhs criteria 90% and 10 % of grade I cases had excellent and good outcome. 80% and 20 % of grade II cases had excellent and good outcome. 75% and 25% of grade IIIa patient had excellent and good outcome, overall 73% excellent outcomeand 27% good outcome. Post operative complications like compartment syndrome, neurovascular deficit, thromboembolism, shortening, stiff knee joint, was not observed in any of the patients. Superficial infection was observed in 2% (6.6%) patients, patient only. Non-union was observed in 1 patient. Anterior knee pain was observed in 20% (i.e. 6 pat.) of total cases in the study. Implant failure in form of broken screw was seen in 1 patient.    1  Anterior knee pain  6  2  Screw pull out  Nil  3  Infection  2  4  Delayed union  Nil  5  Nonunion  1  6  Malunion  Nil  7 Broken nail Nil 8 Broken screw 1 9 Parasthesia Nil Grade III A compound 6       [19][20][21][22] . Smokers had a relatively increased risk of infection and delayed wound healing in other studies, 24.7% has been documented by Hao et al. [22] . In our review, personal habits such as smoking, substance abuse and comorbidities such as diabetes and hypertension were not discussed.

Graph 3: Open Fractures Grades
Operative duration didn't influence significantly in infection rate and there was no significant difference in timing of surgery among these references. The time duration between the injury and operative intervention was from <8 hours to 48 hours in these studies. The initial basic interventions play more of a role in limiting the risk of infections [23] . In general, prolonged operative duration has an increased chance of surgical site infection of 13%, 17% and 37% for every 15mins, 30mins and 60 min of surgery Cheng et al. [24] . Brown et al. reported union time of 36.7 weeks in his study [25] .  [26,27] . In this series nailing resulted in better union rates. Delayed union was noted up to 18.5% in Fong et al. and 18.95% in Mehmood et al. [28,29] . Factors which influenced delayed union in this In a study by Westgeest et al. with a study of 736 subjects concluded that higher Gustilo grade fractures were associated with non-union and delayed union [30] . Delayed union was equally encountered in operative duration of surgery >60 mins and <60mins. Other studies also showed similar result with not much significant difference in the operative duration Lua et al. [31] . In literature distal 1/3rd fractures were reported with delayed union because of the poor blood supply compared to proximal 1/3 rd due to absence of muscle attachment at distal 1/3rd of tibia. A study by Teitz et al. had 26% delayed union with intact fibula [32] . This is due to the tibiofibular discrepancy that occurs and cause altered strain patterns in the tibia and fibula. A routine dynamization was not done in this studies. Dynamization was done in cases where no signs of union were present at 6 weeks to 12 weeks who were on appropriate follow up in each study. Patients who underwent dynamization showed signs of union on their next follow-ups. There were also other factors, which influenced delayed fracture union and the chances of infection. These were delay in early debridement, injury-surgery interval, duration of surgery, associated injuries, personal habits, comorbidities such as hypertension, diabetes and other medical conditions, which were not evaluated in these studies. There were also other complications in the intraoperative period, early and late postoperative periods during the management of these fractures, for which further studies are still required. The economic burden drastically influences the patient's surgical outcome with open tibia fractures. In this review article one study showed no significant difference in the costs of index hospital stay, index procedure, and fractureassociated medications; however, the re-operation costs have to be considered based on the types of complications. Three goals must be met in open tibial fractures: (a) Prevention of infection, (b) Achievement of fracture union (c) Restoration of function. These goals are interdependent and usually are achieved in the chronological order given. For good bony union and functional limb, management of wound and prevention of infection plays the key role for successful treatment for compound fractures. When compared to other study groups our study showed better functional outcome (83%), union rate (14 weeks 4 days) with low infection (6.6%) and non union rate (5%).

Conclusion
Thus it was concluded that in Grade I,II and Grade IIIa tibial diaphyseal fracture, treated with closed intramedullary interlocked nailing had excellent to good outcome, gives satisfactory results with proper alignment, good range of motion, and low infection rate leading to proper union and less patient morbidity