|Year : 2021 | Volume
| Issue : 3 | Page : 66-71
Comparison of clinical and functional outcomes between intramedullary nailing and minimally invasive locking plates for closed extra-articular distal tibial fractures
Vijaya Kumari Thadiparthi1, Alekhya Kunche1, Soma Sekhar Mecharla2, Varun Kumar Paka3, Jameer Shaik4, Naresh Eleshwaram1
1 Department of Orthopaedics, King George Hospital, Visakhapatnam, Andhra Pradesh, India
2 Department of Orthopaedics, Gayatri Vidya Parishad Intitute of Health Science and Medical Technology, Visakhapatnam, Andhra Pradesh, India
3 Department of Orthopaedics, NIMRA Institute of Medical Sciences, Vijayawada, Andhra Pradesh, India
4 Department of Orthopaedics, Chaitra Hospital, Eluru, Andhra Pradesh, India
|Date of Submission||20-Aug-2021|
|Date of Decision||27-Sep-2021|
|Date of Acceptance||01-Oct-2021|
|Date of Web Publication||20-Dec-2021|
Dr. Soma Sekhar Mecharla
Department of Orthopaedics, Gayatri Vidya Parishad Intitute of Health Science and Medical Technology, Visakhapatnam, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
Background: Tibia is the main weight-bearing bone of the leg and accounts for 8-10% of lower limb fractures. Distal tibia fractures are prone to complications due to their subcutaneous nature. It is essential to preserve soft tissue and blood supply in this region to achieve good healing. Controversy exists with regard to use of intramedullary nailing (IMN) or minimal invasive locking plate for management. Aim: This study aims to evaluate and compare clinical and functional outcome of IMN and MIPO in the management of extra-articular distal tibial fractures. Methods: A total of 56 patients with extra-articular distal tibia fracture (OA type 43A1, A2, and A3) admitted to the orthopedic department of our institute between October 2017 and September 2020 were included in the study. One group was treated with intramedullary nail and the second group was treated with minimally invasive locking compression plate. Clinical and functional outcomes in the two groups were evaluated and comparisons were made. Results: The results were interpreted using the Olerud–Molander score according to which excellent outcome was noted in eight patients, good outcome in 45 patients, and fair outcome in 2 patients. One patient in the plating group recorded poor result. Conclusions: Intramedullary interlocking nailing can be considered a very effective modality of treatment indicated for closed extra-articular distal tibial fractures, but is technically demanding. Plating on the other hand can deliver satisfactory results when local soft tissue status is good.
Keywords: Distal tibia fractures, extra-articular, intramedullary nailing, minimally invasive percutaneous plate osteosynthesis, Olerud–Molander ankle score
|How to cite this article:|
Thadiparthi VK, Kunche A, Mecharla SS, Paka VK, Shaik J, Eleshwaram N. Comparison of clinical and functional outcomes between intramedullary nailing and minimally invasive locking plates for closed extra-articular distal tibial fractures. J Orthop Dis Traumatol 2021;4:66-71
|How to cite this URL:|
Thadiparthi VK, Kunche A, Mecharla SS, Paka VK, Shaik J, Eleshwaram N. Comparison of clinical and functional outcomes between intramedullary nailing and minimally invasive locking plates for closed extra-articular distal tibial fractures. J Orthop Dis Traumatol [serial online] 2021 [cited 2022 Jan 24];4:66-71. Available from: https://www.jodt.org/text.asp?2021/4/3/66/332942
| Introduction|| |
Distal tibial fractures account for 8%–10% of all lower limb fractures. Management of distal tibial fractures poses a challenge owing to the subcutaneous location of the bone in this region, proximity to ankle joint, and its precarious blood supply. Meticulous care is essential while handling the soft tissue in this region. Surgical options for managing distal tibial fractures include conventional plating, external fixation, intramedullary nailing (IMN), and minimally invasive percutaneous plate osteosynthesis (MIPPO). External fixators are mainly used for emergency temporary fixation and for open fractures. IMN and MIPPO are the two popular methods for treating closed fractures. There is no clear consensus on the definitive option for closed distal tibial fractures between IMN and MIPPO. This study aims to compare the clinical and functional outcome of IMN and MIPPO technique (using low profile distal tibial locking plate) in the management of closed extra-articular distal tibial fractures.
Aims and objectives
This study aims to determine the effectiveness of IMN and MIPPO technique in the management of extra-articular distal tibial fractures. Evaluation and comparison of the clinical and functional outcomes of IMN and MIPO in the management of extra-articular distal tibial fractures are the objectives included in the study.
This is an interventional study carried out from October 2017 to September 2020 in the department of orthopedics of our institute. A total of 56 patients aged above 18 years (skeletal mature) presenting with closed type of displaced or unstable extra-articular distal tibial fracture (OA type 43A1 A2 and A3) with or without associated fibular fracture were included in the study. Patients with polytrauma, open wounds, bilateral involvement, prior history of injury to tibia, and intra-articular extension were not included in the study. Approval of the ethics committee of the institute has been taken prior to initiation of the study. Written informed consent was taken from all the patients included in the study.
A priori sample size calculation was done with a significance of 0.05 and a power of 80%. It is a two-tailed study with the view that A is not equal to B (A can be better or worse than B). A 10% inflation of sample size was considered to account for dropouts and for those patients lost in follow-up. Null hypothesis: There is no difference in the functional and clinical outcome between the nailing and plating groups. A minimum important clinical difference of 10 points in the Olerud–Molander score between the two groups was considered clinically and statistically significant.
| Methods|| |
A total of 56 patients presenting with closed type of displaced or unstable extra-articular distal tibial fracture (OA type 43A1, A2, and A3) with or without associated fibular fracture were allocated into two groups based on the treatment modality they opted between nailing and plating. One group was treated by IMN, while a locking compression plate (minimally invasive technique) was used in the other group.
After initial evaluation, patients from both the groups were operated between 3 and 8 days following injury with a median of 5 days. An above knee plaster of Paris slab was applied to the injured leg to primarily immobilize the fracture until surgery. Surgery was performed under spinal or epidural anesthesia with proper antibiotic prophylaxis. Fibular fracture if present within 8 cm from joint line or 10 cm from the tip of lateral malleolus with or without an associated syndesmotic injury was fixed using one-third semitubular plate, reconstruction plate, or a rush nail with or without additional syndesmotic screw. If the fibular fracture was of a simple pattern like oblique, transverse, or wedge, it was fixed prior to fixing tibia. Tibia fixation prior to fibula was only considered when a comminution was noticed in fibula, which resulted in loss of height of fibula upon reconstruction.
Patients were operated either under spinal/epidural anesthesia, in a supine position, on a radiolucent table with the limb lying flat on the table for fracture reduction and provisional fixation, followed by a shift to knee flexion of 90° for nailing under fluoroscopic guidance. Patellar tendon splitting approach was used. Guidewire was passed up to the level of subchondral bone only after confirming reduction of the fracture under fluoroscopy. If the distal fragment was large enough, two medio lateral screws were used to lock the nail distally. When the fragment was small, one mediolateral screw and one anteroposterior screw were used.
A 2–3 cm vertical incision was made on the medial aspect of the distal tibia, stopped distal at the tip of medial malleolus. Proximal incision was based on the fracture site and length of the plate used. Manual traction allowed restoration of bone length. For spiral and short oblique fracture patterns that were anatomically reduced, lag screw was used to increase the overall construct stability. A submuscular, epiperiosteal channel was created with the help of an elevator, and the plate was passed in this channel using clamps. Plate and proximal screw orientation over the central region of the tibial surface were confirmed initially with C-arm. Provisional fixation of plate was done using K-wires. Screw fixation was done percutaneously using a combination of C-arm and a second plate superimposed over the first on the skin over the medial aspect of distal tibia. One conventional screw was used to approximate the plate to bone or alternatively the plate was manually held close to the bone when fixing it with initial locking screws. It is essential to approximate the plate close to the bone in the supramalleolar region to avoid soft tissue irritation.
Antibiotics were continued for 5 days following surgery and suture removal was done on the 12th postoperative day in both the groups. X-rays of the leg with both knee and ankle joint were taken in the immediate postoperative period (day 1 after surgery) and during follow-ups. Follow-ups were scheduled at the end of each month for the first 3 months and at 6, 9, and 12 months. If required, patients were followed more regularly beyond 3 months, until satisfactory healing could be established clinically and radiologically. When union was not achieved clinically (absence of pain and tenderness on palpation and on full weight bearing) and radiologically (evidence of union of at least three of the four cortices on follow-up X-rays) before 6 and 9 months, it was considered as delayed and nonunion, respectively.
Active assisted range of motion exercises of toes, foot, ankle, and knee were started as early as permitted by pain. Partial weight bearing was initiated after 3 weeks of surgery. Progression to full weight bearing usually was allowed around 6–8 weeks postsurgery after confirming the status of union on X-rays during follow-up in both the groups.
Clinical assessment of the surgical site, range of movements of the joints, and radiological assessment were all carried out at follow-up for both nailing [Figure 1] and plating [Figure 2] groups. Consistent bony union was defined based on the two criteria of Sarmiento, i.e., ability of the patient to bear weight without pain and visible bridging callus on three out of four cortices across the fracture in the anteroposterior/lateral radiographs. Malunion was defined as varus or valgus deformity more than 5°, anteroposterior angulation more than 10°, and shortening of the limb of more than 1 cm in length. Delayed and nonunion were defined as failure of fracture to unite within 6 and 9 months after surgery, respectively.
|Figure 1: (a) Preoperative X-ray, (b) immediate postoperative X-ray, (c) 6-month follow-up X-ray, (d) one-year follow-up X-ray, (e-g) follow-up clinical evaluation of range of motion knee and ankle|
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|Figure 2: (a) Preoperative X-ray, (b) immediate postoperative X-ray showing fixation with MIPPO, (c) 6-month follow-up X-ray, (d) one-year follow-up X-ray, (e-g) clinical assessment of surgical site and ankle range of movements|
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Functional outcome of the patients was assessed using Olerud–Molander ankle score (OMAS). This scoring system consists of nine parameters such as pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and activities of daily living. Patient is assessed against the nine parameters and the resulting points give a score of 0–100. Patients are graded [Figure 3] as excellent (91–100), good (61–90), fair (31–60), and poor (0–30).
Data analysis was performed using IBM SPSS Statistics for Windows, version V27 (IBM Corp., Armonk, N.Y., USA). Levene's test was used to assess equality of variances. OMA score was considered as nonparametric data and measured statistically using Fisher's exact test, while complication rates assessment was performed using Chi-square test.
| Results|| |
A total of 56 enrolled in the study were successfully followed up to the required period. In this study, eight patients showed excellent outcome, 45 patients good outcome, 2 fair outcome, and one patient in the plating group showed poor result when evaluated using the OMAS. Average OMA scores for IMN group and MIPPO group were 80.62 (Ex 92.5, G 78.5, F 56, and P nil) and 78.5 (Ex 91.5, G 81, F 47, and P 27), respectively. PA and PB for OMA scores of IMN and plating groups were 0.4439 and 0.4127, respectively. The difference in OMA score between the two groups was not considered clinically significant. In the present study, the mean time for union [Figure 4] for nailing was 19.23 weeks and for plating was 22.84 weeks.
The range of motion for the ankle joint was assessed and expressed as a percentage with reference to the ankle on the unaffected limb. The range of motion for the ankle joint [Figure 5] for the nailing group ranged from full (100%) to near normal (>75%) and for the plating group ranged from full to midrange (50%–75%). Among 29 patients of IMN group, 22 (75.86%) had full range of movements and 7 (24.13%) patients had near normal. In plating group, 16 (59.25%) patients had full range of movements, 8 (29.62%) patients had near normal, and 3 (11.11%) patients had midrange of movements. About 40.73% of the MIPPO group had near normal to midrange of movements, whereas it was 24.13% in the nailing group.
|Figure 5: Range of motion of ankle joint assessed in ankle joints of plating and nailing groups|
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The range of movements [Figure 6] for the knee joint for both the nailing and plate groups varied between full to near normal. In the nailing group, the 23 (79.31%) patients had full range of movements and 6 (20.68%) patients had near-normal range of movements. In the plate group, all the 27 (100%) patients had a full range of movements. In the nail group, the mean time for union was 19.23 weeks, and in the plate group, the average time for union was 22.84 weeks. The mean time of union for the nailing group was shorter than the plating group, and this difference was statistically significant (P < 0.024).
|Figure 6: Range of motion of knee joint assessed in ankle joints of plating and nailing groups|
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Chi-square value of 1.0793 (P value 0.298852) and with Fisher's exact test P value of 0.3991. The most common complication noted in the IMN group was anterior knee pain (50% of complications) seen in four patients, all of whom were advised extended physiotherapy program for knee joint, followed by malunion (25%) in two patients. Both the patients with malunion were asymptomatic with minimal effect on their gait pattern and needed no special intervention. Other complications noted in the IMN group were delayed union (12.25%) and superficial skin infection (12.25%) in one patient each. Superficial infection was managed with oral antibiotic and wound care. Patients with delayed union did not need a second procedure to achieve union.
In the MIPPO group, delayed union (27.27%) was reported in three patients. None of the patients with delayed union needed a second procedure. Implant irritation (27.27%) and restricted ankle motion (27.27%) were observed each in three patients out of the total 27 patients in this group.
Implant removal was not necessary in the three patients who complained of irritation which subsided with anti-inflammatory medication over a period of 1 month along with rest. In the one patient who presented with superficial infection in the MIPPO group, oral antibiotics and proper wound care were provided to resolve infection. Ankle stiffness was managed with extended ankle physiotherapy protocol. Nonunion was observed in one patient in this group, who complained of pain even after 33 weeks after surgery. Secondary procedure in the freshening of edges and bone grafting alone was done, retaining the original implant.
| Discussion|| |
Distal tibia exhibits an anatomical transformation in relation to its shaft. This dia metaphyseal region undergoes a gradual broadening of the cortex in comparison to the shaft (from a triangular cross section to more circular one). Management options for distal tibia include IMN, plating, and use of external fixators., Nail is an intramedullary load-sharing device, which attains reduction through indirect means, minimizes soft tissue dissection and vascular damage, and achieves healing through an intact fracture hematoma.,, Malalignment, hardware failure, and the adverse effects on ankle joint are the main drawbacks of this procedure. Shen et al., believed that modified MIPPO had enormous advantage over IMN for extra-articular distal tibia fractures. Lesser infection rates are reported with nailing in a study by Daolagupu et al. Locking plate on the other hand is an internal fixator that allows stable fixation with less chance for infection and soft tissue damage.
The mean age group for IMN group was 38.6 years with a range of 20–57 years. The mean age group for MIPPO group was 41.3 years with a range of 21–56 years. This was close to the mean age reported by Seyhan et al. (2013) (40.32 years for nail and 39.67 for plate) and Vallier et al. 2011 (38.3 years for both plate and nail). Among 56 patients, there were 39 (69.64) males and 17 (30.35%) females. Most of the reported studies showed a male preponderance in tibial fractures. Male preponderance (69.64%) for such kinds of injuries was high in studies like Vallier et al. (81%) possibly due to the fact of male dominance over the female in travelling, occupational injuries, etc. The most common mode of injury in both the groups was RTA in the present study, which constitutes 57.14% and is consistent with study conducted by Eknath et al. In the study of Vallier et al., 54.7% of cases were reported to be involved with RTA.
Among 29 patients in the IMN group, 18 sustained 43 type A1 fractures and 11 sustained 43 type A2, and among 27 patients in the plating group, 4 sustained 43 type A1, 6 sustained 43 type A2, and 17 sustained 43 type A3. The mean duration of surgery for the IMN group was 51.33 min and for the MIPPO group was 59.6 min. It is comparable with the study conducted by Eknath et al., where the average surgical was 57.20 in nailing and 70.36 in plating. The average surgical time is slightly higher in the study conducted by Guo et al., which is 81.23 in nailing and 97.9 plating.
In the study conducted by Guo et al. and Eknath et al., the average time for union was about 16–20 weeks in both groups. In the present study, the average time for union for nailing was 19.23 weeks and for plating was 22.84 weeks. The average time of fracture union is less in the study conducted by Li Y et al. and more in the study conducted by Fang et al. when compared to the present study. Hazarika et al. using MIPPO technique for 20 tibial fractures reported 87.5% of good to excellent results. Ronga et al. reported 95% union rate with few complications using the locking plates for these fractures.
Locking plates provide stability through the screw plate interface (angular and axial). It preserves periosteal blood supply and enhances healing. These implants are better suited for periarticular fracture patterns than the tibial metaphyseal region. IMN works on the principle of load sharing, which is considered as its main asset. Mioc et al. suggested that results with both nailing and MIPPO are similar with respect to OMA scores. Both MIPPO and IMN avoid opening of fracture site and further disruption of biology at fracture site. Spiral and oblique fracture patterns yield better result with simulated weight bearing in clinically displaced fractures treated with nailing. Expert tibial nailing is another option that is safe and effective for metaphyseal tibial fracture management.
The complication rate [Table 1] in the MIPPO group was high compared to the IMN group. A complication rate of 27.58% was noted in the IMN group largely due to anterior knee pain and malunion. The MIPPO group was associated with complications such as superficial infection, implant failure, delayed union, and nonunion. Anterior knee pain and malunion were noticed more likely in the IMN group according to Bleeker et al., 2012. Immediate weight bearing can reduce the nonunion incidence in extra-articular distal tibia fractures as proposed by Jian Zhuang.
|Table 1: List of complications encountered along with number of patients affected in each group|
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In the present study, there was no reported incidence of nonunion noted in nailing. One case of nonunion was reported in the plating group. There was 1 case of delayed union in the nailing group and three patients with delayed union in the plating group which required secondary procedure. Valier et al. in their study featuring 132 cases of distal tibial fracture managed with interlocking nail observed an incidence of 27% of malunion. The rate of malunion was little lower in the present study. Delayed union is seen in one patient (3.44%) in the nailing group and three patients (11.11%) in the plating group in the present study, which further required secondary procedures. However, it is essential here to understand that rigid anatomical fixation may obscure signs of nonunion for many months. Two cases (6.89%) of malunion were seen in nailing group similar in incidence compared to study conducted by Chen G et al. Delayed union is relatively high in the study conducted by Fang et al., Li Y et al., Mauffrey et al., reported more cases of delayed union than plating in most of the studies he conducted on distal tibial fractures. Anterior knee pain is present in four patients (13.79%) out of 29 patients in the nailing group, which is in consistence when compared to other studies conducted by Fang et al. and Li Y et al. Expert tibial nail was launched in 2005 to overcome the shortcomings of interlocking nail with provision for a variety of distal locking options that include mediolateral, anteroposterior, and oblique planes. This advantage is pronounced in handling osteoporotic bone and more distal fractures. However, in spite of these modifications, it still reported a 12% nonunion rate and 14% malunion rate. Modern sophisticated version is called the TN-A (advanced tibia nail) with built-in polyether ether ketone inlays facility in the proximal and distal interlocking section of the nail. It improves construct stability without compromising the flexibility of the nail. New profile locking screw design allows these screws to be inserted almost flush to the bone, which decreases the soft tissue irritation.
The main limitations of the study are small sample size and shorter duration of follow-up. Randomized trials involving larger number of patients with longer duration follow-up are needed in the future to better establish the superiority of one treatment modality over the other.
| Conclusions|| |
This study recorded the mean duration of union to be shorter for the nailing group compared to the plating group, and that was statistically significant. Malunion rates were higher in the nailing group. Wound-related complications were noted higher in the MIPPO group. However, there was no statistically significant difference in functional outcome between these two options. Anterior knee pain, angulation, and technical expertise are the problems to be considered when opting for a nail. MIPPO technique is productive when the soft tissue status is good, but it comes at a price of ankle stiffness and wound-related complications. Nailing on the other hand is technically demanding, useful option for patients with poor soft tissue status, or comorbidities that are likely to affect wound healing. Taking the above consideration, it may be stated that factors such as soft tissue status, quality of bone, and fracture configuration will have an influence on the final choice of implant and the outcome. To conclude, intramedullary interlocking nailing can be considered a very effective modality of treatment indicated for closed extra-articular distal tibial fractures than plating, provided the demand of technical expertise is met with.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]