|Year : 2015 | Volume
| Issue : 3 | Page : 238-243
Interlocking nail and Ender's nail in management of diaphyseal fracture of tibia in a rural population of a developing country
Soumya Ghosh1, Brajesh Kumar Sirdar1, Arunima Chaudhuri2, Soma Datta3, Pradip Kumar Ghosh1, Ahkilesh Kumar1
1 Department of Orthopedics, Burdwan Medical College and Hospital, Burdwan, West Bengal, India
2 Department of Physiology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India
3 Department of Pathology, Burdwan Medical College and Hospital, Burdwan, West Bengal, India
|Date of Web Publication||2-Sep-2015|
Krishnasayar South, Borehat, Burdwan - 713 102, West Bengal
Introduction: Intramedullary nail fixation has become the standard of treatment for tibial shaft fractures. Aims: The aim was to compare the results of the interlocking nail with Ender's nail, which are less expensive in our country for diaphyseal fracture of the tibia. Materials and Methods: This prospective pilot project was conducted on 30 patients after taking institutional ethical clearance and consent of the subjects in a time period of 1-year. Fifteen patients were treated with intramedullary nailing (Group I) in the tertiary care hospital while 15 with Ender's nail (Group II) in a rural hospital (with the lack of modern operative facilities). Results: The skeletal injury was classified according to AO/OTA classification. The majority of the patients were operated in 2 nd week of injury in our study. Average time taken for Ender's nail was 41.33 min and the average time for interlocking nail was 74 min, and the difference was highly significant (P < 0.01). The mean c-arm shot needed 18.66 and 49.00 for Ender's nail and interlocking nail, respectively; which was highly significant (P < 0.01). The majority of Ender nail group were allowed partial weight-bearing after 6 th weeks postoperatively while in interlocking nail group it could be allowed as early as 3 weeks. The majority of cases shows sign of clinical union in 8-12 th week in the interlocking group (%) and 13-16 th week in Ender's nail group. About 60.00% cases in Ender group and 86.66% cases in interlocking nail group had excellent results. Conclusion: Interlocking nails should be the first implant of choice to operate tibial diaphyseal fractures and the use Ender's nails should be done with caution in selected low-demand patients with suitable fracture patterns having financial constraints as well.
استعمال مسامير التشبيك ومسامير أندر في علاج الكسر المشاشي لعظم الساق الاعظم في السكان الريفيين في احدى الدول النامية.
الخلفية:- أصبح التثبيت الداخلي باستخدام مسامير النخاع الخيار الأمثل لعلاج كسور جذع عظم الساق الأعظم .
الهدف :- مقارنة نتائج استخدام مسامير التشبيك مع مسامير اندر (Ender's nail) والتى تعد أرخص ثمنا وقد تستخدم للكسر المشاشي لعظم الساق الاعظم.
المواد والطرق: تم تطبيق هذا المشروع على 30 مريضاً بعد عمل الأجراءات الاخلاقية واخذ الموافقة على المشاريع لمده عام . عولج 15 مريضاً باستخدام مسامير النخاع .
( المجموعه الاولى ): فى مستشفي متخصص و15 مريضاً باستخدام مسامير اندر واجريت في مستشفي ريفي مع عدم توفر التسهيلات الجراحية الحديثة.
النتائج :- الاصابات الهيكلية صنفت حسب تصنيف A0/TA . في دراستنا خضع غالبية المرضى للجراحة في الأسبوع الثاني من الإصابة وكان معدل الزمن الذى استغرق لمسامير اندرهو 41.33 دقيقة ومعدل الزمن للتشبيك هو 47.00 دقيقة وقد كان الفرق واضحا (0.01 > P ). متوسط طلقة c-arm المطلوب 18.66 لمسامير اندر و 49.00 لمسامير التشبيك. غالبية المرضى الذين استخدموا مسامير اندر سمح لهم بإجراء شد جزئي بالأثقال بعد مرور 6 أسابيع من إجراء العملية ، بينما سمح للمرضى الذين استخدموا مسامير التشابك بالشد بعد مرور 3 أسابيع. وأظهرت غالبية الحالات التئاما في الفترة بين 8-12 أسبوعا في مجموعة التشابك وما بين 13-16 أسبوعا في حالات مجموعة اندر. اظهرت 60% من حالات مجموعة اندر و 86.66% من حالات التشابك نتائج ممتازة.
الخلاصة: تعد مسامير التشابك الخيار الأفضل في عمليات علاج الكسر المشاشي. يجب توخي الحذر عند استخدام مسامير اندر عند بعض المرضى المختارين ذوي الكسور المناسبة والدخل المحدود.
Keywords: Ender nail, interlocking nail, tibial fracture, treatment
|How to cite this article:|
Ghosh S, Sirdar BK, Chaudhuri A, Datta S, Ghosh PK, Kumar A. Interlocking nail and Ender's nail in management of diaphyseal fracture of tibia in a rural population of a developing country. Saudi J Sports Med 2015;15:238-43
|How to cite this URL:|
Ghosh S, Sirdar BK, Chaudhuri A, Datta S, Ghosh PK, Kumar A. Interlocking nail and Ender's nail in management of diaphyseal fracture of tibia in a rural population of a developing country. Saudi J Sports Med [serial online] 2015 [cited 2019 Nov 20];15:238-43. Available from: http://www.sjosm.org/text.asp?2015/15/3/238/164291
| Introduction|| |
Tibia is exposed to frequent injury; it is the most commonly fractured long bone. By its subcutaneous location throughout its length, also considering its precarious blood supply and decreased soft tissue coverage, delayed union, nonunion, and infection are very common and thus even today treatment of unstable shaft fracture of tibia is difficult. Various treatment modalities are used in the management of this fracture, which include conservative management with the cast and functional bracing, intramedullary fixation, plating, and external fixation. Intramedullary nail fixation has become the standard of treatment for both femoral and tibial shaft fractures. ,,,,
Functional bracing is reserved for undisplaced and minimally displaced fractures with a fracture pattern that can allow early weight-bearing to prevent delayed union or nonunion. Although plating provide stable fixation, it is not appropriate for tibial diaphyseal fractures due to it subcutaneous location and associated with unacceptably high incidence of infection in open fracture and further devascularizing the bone causing weakening under the plate and not allowing early weight-bearing. ,,,,,
Ender nail is an unreamed, intramedullary device slightly curved in shape, semi-elastic in nature, round in cross-section. It is available in different sizes and diameters, made up of stainless steel. The tip of the Ender nail is beveled, and the edge of the tip is smooth to negotiate in the medullary cavity easily even in the osteoporotic bones. The other end is paddle shaped with an eye that remains outside the canal. 
Ender nails are used usually in a pair, and each nail is precurved to achieve three-point fixation. Elastic nail permits biological healing and callus formation in abundance. This is achieved by minimizing periosteal stripping by way of minimally invasive approach and in most cases by a close reduction. The elasticity of the construct allows for the ideal circumstances of micro-motion for rapid fracture healing. 
Locked intramedullary nailing is currently the preferred method for surgical treatment of the tibial diaphyseal fracture. It provides more stable fixation and prevents rotation. ,, It may be done either with reaming or without reaming. The method needs specific instruments and facilities such as image intensifier and a complete set of nails, screws, and insertion devices, which must be checked regularly so that the damaged parts can be replaced. ,, Such facilities are not accessible in many hospital in our country. Ender's nailing can be a safe and alternative method of fixation of fracture shaft of the tibia in rural India for the poor patient in "not well set-up."
The objective of this study was to compare the results of the interlocking nail with Ender's nail, which are less expensive in our country for diaphyseal fracture of the tibia.
| Materials and Methods|| |
This prospective pilot project was conducted in a tertiary care hospital of a developing country on 30 patients after taking institutional ethical clearance and consent of the subjects in a time period of 1-year. Fifteen patients were treated with intramedullary nailing (Group I) in the tertiary care hospital while 15 with Ender's nail (Group II) in a rural hospital (with the lack of modern operative facilities).
Inclusion criteria: Patients aged between 18 and 65 years with tibial diaphyseal fracture (Gustilo-Anderson type I, II fracture) who were medically physically and mentally fit with duration of fracture of maximum 3 weeks were included in the study. Exclusion criteria: Patient having concomitant fracture in ipsilateral limb, serious medical co-morbidities (diabetes mellitus, rheumatic arthritis etc.), pathological fractures, open fracture of Gustilo-Anderson type III, and comminuted fracture (42C) were excluded.
After primary ATLS survey and resuscitation, thorough evaluation of the fracture were done with special emphasis on wound size, degree of contamination, degree of communition and bone loss (if any), neurovascular deficit (if any). Careful history was recorded followed by a clinical examination. Preoperative X-ray was done; relevant investigation was done followed by preanesthetic check-up.
Under spinal or epidural anesthesia, the patient was positioned on a fracture table with the injured extremity placed over a right-angle support. The procedure was performed on a radiolucent table with a sterile bump under the operative extremity. In the setting of an open fracture, meticulous debridement preceded fracture fixation. 1-3 cm anteromedial and anterolateral oblique skin incisions are made over the flare of the proximal tibial metaphysis, and dissection was carried down to bone adjacent to the medial and lateral margins of the tibial tubercle. The nails were introduced through holes made with an awl on each side of the tibial tuberosity. The appropriate length of nail was determined by measuring the distance between 2 cm proximal to the tibial tuberosity and the medial malleolus on the intact leg or alternatively by placing the nail on the anterior surface of the leg while visualizing the distal tibial plafond with the image intensifier. Both the medial and lateral nails were driven distally in the tibia until the tips reach the fracture, as seen by image intensification. Using traction on the foot, the fracture was slightly distracted just before passage of the nails across the fracture site. The fracture was then reduced, and one nail passed just beyond the fracture site to help to hold the reduction then second nail was advanced in the distal segment and subsequently both nails were advanced further. The tip of the nail should be 1-2 cm from the tibial plateau. 3.5, 4.0, and 4.5 mm nails were used in various combinations to fill the canal for added rotational, angular, and translational stability. With medial cortical comminution, one additional nail were used on lateral side and vice-versa.
Spinal, epidural or general anesthesia was given, and the patient was placed supine on the operation table. Thigh is supported with sand bags. The limb was prepared and draped with the standard aseptic technique allowing full exposure of the knee to above the patella and enough access to the distal tibia for locking screw placement.
Nailing can be done using either a fracture table or a standard radiolucent operating table. The patient can be set-up on a nailing table with a pad placed under the popliteal fossa, the knee bent to at least 90°, and traction is applied to the foot either through a calcaneal pin or by strapping the foot to the fracture table. An alternative method of nailing for tibial fractures is to use manual traction and to flex the knee by 110° with the patient lying supine. An assistant provides both traction and rotational control, and the nailing is performed in a conventional manner.
A longitudinal incision, 5 cm long, was made medial to the patellar tendon and the patellar tendon was retracted laterally. It may be necessary to extend the incision farther proximally through the skin and subcutaneous tissue only to protect the soft tissues around the knee during reaming and nail insertion. The medullary canal was opened with the curved bone awl in the midline just proximal to the tibial tubercle at the level of the tip of the fibular head (approximately 1.5 cm distal to the knee joint) behind the patellar tendon and in line with the center of the medullary canal on the anteroposterior (AP) view. After the entry point had been connected to the medullary canal, an olive tipped guide wire was passed. The fracture was reduced by longitudinal traction and manipulation. Rotational alignment was obtained by aligning the iliac crest, patella, and second toe of the foot. After reduction, the guide wire was passed in the distal fragment and centered in AP and lateral projections. After sequentially incremental reaming, the guide wire was exchanged and appropriately sized nail, mounted on aiming device was inserted. The appropriate nail length can be calculated by either using a graduated guide wire or by placing a second guide wire alongside the leg and then measuring this wire. Tibial nails of 9 mm or 10 mm diameter were used most frequently. In few cases, in which closed reduction was very difficult, the open reduction was done with a 3-5 cm long incision centered over the fracture site. Proximal locking was done by means of the jig; the fracture was impacted, and distal locking done by freehand technique.
Postoperative care and rehabilitation
Patients were kept under strict observation for the first 24 h of postoperative period. Intravenous fluid 3 rd generation cephalosporin are administered to the patients routinely. After recovery from anesthesia patients were instructed do the active toes movement. Parenteral antimicrobials were withdrawn after 3 days then oral antimicrobials were started and continued for a variable period of time depending on the wound condition. Stitch removal was done after 2 weeks postoperatively.
From the 2 nd postoperative day, the patient was encouraged to do mild mobilization exercises of the joints concerned. Stitches were removed after a 2 nd week. Quadriceps exercises and ankle exercises were encouraged after the subsidence of pain (2-3 days). Active knee bending was allowed after stitch removal.
Partial weight-bearing was allowed when the patient could perform active straight leg raising (SLR).
Considering fracture pattern and method of fixation full weight-bearing was allowed only after evidence of clinical and radiological union. All patients were followed up for a minimum of 1-year.
Fracture union was assessed clinically and radiologically at an interval of 4 weeks for first 2 months postoperatively and 6 weekly thereafter. Complications were identified and treated accordingly. Functional outcome was done according to Johner and Wruhs criteria. 
| Results|| |
The average age of the patient in the study was 31.43 years, and 86.66% were males and 13.33% females. Right, tibia was affected in 66.66% and the left tibia in 33.33% of all patients. A motor vehicle accident was the most common mode of injury in both males and females accounting for 80% of cases. Of 24 patients who sustained motor vehicle accident 21 were males and 3 were females. Fall from height was the second most common cause of injury. The skeletal injury was classified according to AO/OTA classification. Simple oblique fracture (42A2) was the largest group having 14 patients comprising 46.30 of total [Table 1].
The majority of the patients (18 patients) were operated in 2 nd week of injury in our study. One patient was operated after 3 weeks. Average time taken for Ender's nail was 41.33 min and the average time for interlocking nail was 74 min and the difference was highly significant (P < 0.01). The mean c-arm shot needed 18.66 and 49.00 for Ender's nail and interlocking nail, respectively which was highly significant (P < 0.01). Partial weight-bearing was allowed earlier in interlocking nail group than in Ender nail group. The majority of Ender nail group were allowed partial weight-bearing after 6 th weeks postoperatively while in interlocking nail group it could be allowed as early as 3 weeks. The majority of cases shows sign of clinical union in 8-12 th week in the interlocking group (%) and 13-16 th week in Ender's nail group. About 60.00% cases in Ender group and 86.66% cases in interlocking nail group had an excellent result.
| Discussion|| |
Intramedullary nailing is the gold standard in the treatment of diaphyseal long-bone fractures. The options include (1) a single unlocked nail (e.g., Lottes nail, V nail or Küntscher-Herzog nail, Küntscher nail, Rush rod); (2) a single, large-diameter, interlocking tubular nail, with or without reaming; (3) multiple flexible intramedullary pins (although this is less popular); and (4) an expandable nail. The most important indication for the use of an intramedullary nail in tibial fractures is an unstable diaphyseal tibial fracture. , The goal of management is a solid union within a reasonable time period. Results should be comparable to those of closed management. Treatment failures should be minimized, and secondary procedures such as bone grafting and nail exchanging should be avoided in order to decrease the prevalence of implant-related complications such as nail and cross-bolt breakage and pin track infections. Intramedullary nails are the ideal implants for closed diaphyseal, short oblique, simple transverse or short oblique fractures with or without comminution. ,,,,,,,, In the present study, only 42A and 42B fracture were included. Simple fracture constituted of 73.33% of cases. In most of the patients (60%) nailing was done in 2 nd week of injury. Delay of more than 7 days was due to late presentation of the patient often referred from a remote area, delay in preanesthetic fitness. Operation after 2 weeks often led to difficulty in the closed reduction and increased the operative time.
Patient age is one of many potential risk factors for fracture nonunion. Zura et al. in 2015  confirmed the hypothesis that older patients (≥60) with fracture risk factors treated with low-intensity pulsed ultrasound (LIPUS) have similar heal rate (HR) to the population as a whole. They evaluated the impact of age in conjunction with other risk factors on HR in LIPUS-treated patients with fresh fracture (≤90 days old). The average age of the patient in the present study was 31.43 years, and 86.66% were males and 13.33% were females. This may be the cause that we did not observe any nonunion in the present series. Average operative time for Ender nailing was 41 ± 9.90 min and for interlocking nail was 74 ± 12.42 min. In 3 patients, Ender nailing could be done within 30 min. The majority (12 cases) of Ender nailing was performed within 45 min while all cases of the interlocking nail were done in more than 1 h. There was statistically significant (P = 0.006) less fluoroscopy time for the Ender's nail group than interlocking locking group. Average blood loss in Ender nailing was significantly lower than in interlocking nailing while more blood loss in the interlocking group because of reaming. Average blood loss in Ender group was 92 ml, and the interlocking group was 242 ml. This difference in blood loss was not statistically significant (P = 0.437). Partial weight-bearing allowed when the patient could perform active SLR and callus became visible on a radiograph. The locked intramedullary nail provides more stability hence partial weight-bearing was allowed earlier in interlocking nail group than in Ender nail group. All patients of Ender nail group were allowed partial weight-bearing after 6 weeks postoperatively while in interlocking nail group it could be allowed as early as 3 weeks.
The union criterion adopted was the presence of at least 3 healed cortices seen in 2 radiographs (AP and lateral), in addition to the absence of pain and mobility at the fracture site. In the present study, the average time of union in Ender nail group is 16.86 weeks and in interlocking nail group is 15.53 weeks. About 96.66% patients treated with Ender nails while 100% patients treated with interlocking nail achieved union. In our study series, superficial infection occurred in 3 cases (10%) 2 in interlocking group and 1 in Ender nail group which healed with dressings and antibiotics therapy except in one case in interlocking group (progressed to deep infection locking bolt, which was healed with removal of bolt debridement of wound and antibiotics).
In our study, we considered cut off time for the delayed union as 24 weeks. With this criterion, we found six cases (20%) of delayed union, 4 (13.33%) in Ender nail group. This may be due to inadequate immobilization of fracture by Ender' nail. Delayed union in two cases of interlocking nail group is due to locked fixation that prevents compression at the fracture site. Dynamization was performed in two cases of interlocking nailing. To compare the locked, unreamed intramedullary nail with Ender pins in the treatment of open Gustilo grade I or II or closed tibial diaphyseal fractures of type A, B or C2 of the AO classification Sakaki et al.  conducted the study in 2007. Forty-four patients with unilateral tibial diaphyseal fractures were treated with intramedullary nails or Ender pins. Twenty patients were treated with an unreamed intramedullary nail. Twenty-four patients were treated with Ender pins. The main parameters analyzed were type of reduction, complications, union rate, deformities, joint mobility, pain, gait, effort capacity, the presence of neurovascular disorders, and complaints related to the synthesis material. During 1-year of follow-up, the fractures of 90.0% of the patients with intramedullary nails and 95.7% of patients with Ender pins healed within an average of 21.5 weeks and 20.9 weeks, respectively. The significant findings were as follows: Patients treated with Ender pins had less mobility of the subtalar joint; patients treated with intramedullary nails were more likely to have pain in the knee; both groups showed shortening of the tibia at the end of 1-year of treatment. They concluded that the two methods were similar in the treatment of type A, B, and C2 tibial diaphyseal fractures.
In the present study, mal-union was defined as varus or valgus deformity >5°, antecurvation or recurvation deformity >10°, rotational deformity >10°, and shortening >1.5 cm. With these criteria, 5 cases of mal-union were found, 4 in Ender's nail group and 1 in interlocking nail group. Thus, the incidence of mal-union was 16.66%. Sakaki et al.  reported a mal-union rate of 15.9%. Sixty patients with tibial diaphyseal fracture were included in a study.  All fractures were manually reduced and fixed using reamed intramedullary nailing. Eighteen patients had malrotation of more than 10°. Malrotation was greater than 15° in seven cases. Good or excellent rotational reduction was achieved in 70% of the patients. Considering the high incidence rate of tibial malrotation following intramedullary nailing, we need a precise method to evaluate the torsion intraoperatively to prevent the problem.
In the present series, out of 4 mal-united fractures in Ender group, two patients had wedge fracture. Shortening more than 1.5 cm was found more common in Ender nailing. There were four patients with shortening more than 1.5 cm in Ender group while only one in the interlocking group. This difference was significant and may be attributed to more compression and collapse at fracture site in Ender nailing. This factor may also be a cause of higher incidence of deformity in coronal and sagittal plane. Restricted knee joint motion more than 75% was found in two case of interlocking nail and 1 in Ender nail. Restricted ankle joint motion more than 50% was found in three cases of Ender's nail. Proximal migration of Ender nail was the cause of pain and knee motion restriction. The nail was removed as the union was achieved.
We had conducted another study  previously and recognized that plaster of Paris cast still remains a choice of treatment of an isolated, closed tibial shaft fracture in a developing country and there is urgent need to upgrade rural centers for improvement of mode of treatment. Complications included: Superficial infection, deep infection, delayed union, nonunion, stiffness of proximal, and distal joints deformity or malignment. The mean time to union was 19 weeks after management with a cast and 13 weeks after management with nailing (P < 0.05). Only 2 cases in nail group complicated with superficial skin infection and only 2 cases complicated with deep infection. Deformity like shortening in length of limb in plaster group <1 cm in 12 cases, >1.5 cm in 6 cases, and no shortening in rest of the cases, whereas in nail group <1 cm in 4 cases and >1 cm in 2 cases. Excellent result found in 13 cases in nail group and 8 cases in cast group. Good result found in 6 cases in nail group and 16 cases in cast group. Fair result found in 2 case in nail group and 6 cases in cast group. Poor result found only in cast group 4 cases. The mean time to radiographic union was 19 weeks for the 34 patients who had been managed with a cast compared with 13 weeks for the 34 patients who had been managed with nailing (P < 0.05). A nonunion occurred in four patients who had been managed with a cast and in two patients who had nailing. Four patients who had a nonunion after management with a cast had intact fibula. Six patients who had been managed with a cast had shortening of more than 1.5 cm. No patient had shortening of more than 1.5 cm after intramedullary nailing. These differences were significant (P < 0.05, Chi-square test). The 34 patients who had nailing returned to work significantly sooner than did the 34 who had been managed with a cast (mean, four compared with 6.5 months; P < 0.05).
High-risk patients should not be subjected to extremely lengthy or complicated surgeries. Severely injured patients do not tolerate excessive blood loss or lengthy procedures, so rapid resuscitation and stabilization may be the best initial option.  Hence, Ender nailing still remains a valuable alternative for operation in a developing country like India, where lack of manpower, modern facilities, and poverty is still a burning problem for the society.  In a developing country like India, in rural areas still closed reduction remains the only mode of treatment due to lack of modern operative facilities and trained manpower. Effective screening of nonunion risk may decrease morbidity and subsequent healthcare resource use and costs.
| Conclusion|| |
Interlocking nails should be the first implant of choice to operate tibial diaphyseal fractures and the use Ender's nails should be done with caution in selected low-demand patients with suitable fracture patterns having financial constraints as well.
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