Fractures of the tibial shaft represent one of the most common long bone fractures encountered in orthopedic practice, constituting approximately 2% of all fractures and 36% of all long bone fractures.[1] Due to the subcutaneous location of the tibia, midshaft tibial fractures are frequently exposed to direct trauma and are prone to complications such as delayed union, nonunion, and infections.[2] These fractures often result from high-energy trauma like road traffic accidents and falls from height but can also occur due to low-energy injuries in osteoporotic bone.

Management of midshaft tibial fractures poses a considerable challenge to orthopedic surgeons, primarily because the tibia bears significant weight during gait and has a relatively poor soft tissue envelope, especially along its anteromedial surface.[3] Appropriate fixation is critical not only to achieve anatomical alignment and stable fixation but also to allow early mobilization, reducing the risk of joint stiffness, muscle atrophy, and thromboembolic events.

Historically, treatment options for midshaft tibial fractures ranged from conservative methods such as casting and traction to surgical intervention. Conservative management often led to prolonged immobilization, malunion, and joint stiffness, thereby favoring the trend toward surgical fixation in displaced fractures.[4]

Among surgical options, two main techniques have gained prominence: plate fixation and intramedullary (IM) nailing. Plate fixation involves open reduction and internal fixation (ORIF) using compression or locking plates applied along the medial or anteromedial tibial surface.[5] This technique provides rigid fixation, allowing anatomical reduction and direct visualization of the fracture site, which can be advantageous in complex fracture patterns, including segmental and comminuted fractures.

Intramedullary nailing, introduced in the mid-20th century, has become the gold standard for many tibial shaft fractures due to its biomechanical advantages. The IM nail is a load-sharing device inserted into the medullary canal, permitting minimal soft tissue disruption and promoting early weight-bearing.[6] It acts as an internal splint, providing relative stability that allows secondary bone healing through callus formation.

Aim

To compare the clinical and radiological outcomes of plate fixation versus intramedullary nailing in midshaft tibial fractures.

Objectives

1. To evaluate and compare the time to fracture union between plate fixation and intramedullary nailing.
2. To assess and compare the functional outcomes and complication rates in patients treated with plate fixation versus intramedullary nailing.
3. To analyze the radiological alignment and incidence of malunion or nonunion in both surgical groups.

Source of Data

The data for this study were collected from patients diagnosed with midshaft tibial fractures who were admitted to the Orthopedic Department.

Study Design

This was a prospective observational comparative study.

Study Location

The study was conducted at the Orthopedics Department.

Study Duration

The study duration was 12 months, from January 2024 to December 2024.

Sample Size

A total of 120 patients with midshaft tibial fractures were enrolled and divided equally into two groups: 60 patients treated with plate fixation and 60 patients treated with intramedullary nailing.

Inclusion Criteria

• Patients aged between 18 and 65 years.
• Patients with closed or Gustilo-Anderson type I and II open midshaft tibial fractures.
• Fractures amenable to both plate fixation and intramedullary nailing as per surgeon’s evaluation.
• Patients who gave informed consent to participate in the study.

Exclusion Criteria

• Patients below 18 or above 65 years of age.
• Patients with pathological fractures or fractures associated with neurovascular injury requiring urgent intervention.
• Gustilo-Anderson type III open fractures.
• Patients with multiple fractures of the ipsilateral limb.
• Patients with pre-existing lower limb deformities or infections.
• Patients medically unfit for surgery or who refused surgery.

Procedure and Methodology

Patients were assessed clinically and radiologically following admission. Initial stabilization and management were done according to Advanced Trauma Life Support (ATLS) guidelines. After evaluation, patients were allocated into two groups based on the surgical procedure performed:

• Plate Fixation Group: Open reduction and internal fixation were performed using a pre-contoured locking compression plate or dynamic compression plate through a medial or anteromedial approach under appropriate anesthesia. Care was taken to preserve the soft tissue envelope and periosteum as much as possible. After fracture reduction and fixation, the wound was closed in layers.
• Intramedullary Nailing Group: Closed or minimally invasive techniques were used to insert an appropriately sized intramedullary nail through the proximal tibial entry point under fluoroscopic guidance. Static or dynamic locking screws were applied as per fracture pattern and surgeon’s discretion. Care was taken to achieve acceptable alignment in all planes before final locking.

Postoperative care included pain management, limb elevation, and intravenous antibiotics as per protocol. Early range of motion exercises for the knee and ankle joints were encouraged. Partial weight-bearing was started as per fracture stability and patient tolerance, progressing to full weight-bearing when clinical and radiological signs of union were evident.

Follow-up was done at regular intervals (2 weeks, 6 weeks, 3 months, 6 months, and 1 year) with clinical examination and radiographs to assess fracture healing, alignment, and functional recovery. Complications such as infection, malunion, nonunion, implant failure, and need for revision surgery were documented.

Sample Processing

Radiographs were processed and evaluated for evidence of callus formation, fracture line disappearance, and cortical continuity. Union was defined radiologically by bridging callus across at least three cortices and clinically by the absence of pain or tenderness at the fracture site with full weight-bearing.

Functional outcomes were assessed using standardized scoring systems such as the Johner-Wruhs criteria or Lower Extremity Functional Scale (LEFS).

Statistical Methods

Data were entered into Microsoft Excel and analyzed using SPSS software version XX. Descriptive statistics such as mean, standard deviation, and percentages were calculated. Comparative analyses between groups were performed using the Chi-square test for categorical variables and Student’s t-test for continuous variables. A p-value of <0.05 was considered statistically significant.

Data Collection

Data were collected using a pre-designed proforma capturing demographic details, fracture characteristics, operative details, perioperative complications, radiological findings, and functional outcomes at each follow-up visit.

Table 1: Baseline Demographic and Clinical Profile of Study Participants (n=120)

The study included 120 participants equally divided between plate fixation (n=60) and intramedullary nailing (n=60) groups. The mean age in the plate fixation group was 38.3 years (SD 11.6) compared to 40.1 years (SD 10.9) in the intramedullary nailing group, showing no statistically significant difference (t = -1.03, 95% CI: -5.24 to 1.63, p = 0.305). The gender distribution was similar in both groups with males comprising 63.3% and 68.3%, respectively (χ² = 0.34, p = 0.558). Laterality of injury also did not differ significantly, with right-sided fractures accounting for 53.3% in plate fixation and 48.3% in nailing groups (χ² = 0.26, p = 0.609). Road traffic accidents were the predominant mechanism of injury in both groups (76.7% vs. 73.3%, χ² = 0.16, p = 0.689). The incidence of open fractures classified as Gustilo-Anderson type I and II was comparable at 13.3% and 15.0%, respectively (χ² = 0.07, p = 0.789).

Table 2: Time to Fracture Union (weeks) in Plate Fixation versus Intramedullary Nailing (n=120)

**Significant p-values marked with **

Significant differences were noted in time to fracture union favoring intramedullary nailing. The mean time to clinical union was shorter in the nailing group at 16.7 weeks (SD 3.8) compared to 18.9 weeks (SD 4.2) for plate fixation (t = 3.02, 95% CI: 0.82 to 3.72, p = 0.003). Similarly, radiological union occurred earlier with nailing (mean 18.9 weeks, SD 4.7) versus plating (mean 21.4 weeks, SD 5.1) (t = 2.85, 95% CI: 0.77 to 4.29, p = 0.005). Although delayed union beyond 24 weeks was more frequent in the plate group (15.0%) compared to the nailing group (6.7%), this difference did not reach statistical significance (χ² = 2.31, p = 0.128).

Table 3: Functional Outcomes and Complications (n=120)

Functional outcome assessed by the Lower Extremity Functional Scale (LEFS) demonstrated better results in the intramedullary nailing group, with a mean score of 78.1 (SD 7.3) compared to 73.8 (SD 8.4) in the plate fixation group (t = -3.04, 95% CI: -7.50 to -1.38, p = 0.003). Infection rates, both superficial and deep, did not differ significantly between groups. Superficial infection was observed in 10.0% of plate fixation patients versus 5.0% in the nailing group (p = 0.273), and deep infections were rare in both groups (3.3% vs. 1.7%, p = 0.560). Implant failure rates were low and similar (5.0% vs. 3.3%, p = 0.610). Notably, persistent knee pain, though higher in the nailing group (16.7% vs. 6.7%), showed a trend but did not reach statistical significance (p = 0.075).

Table 4: Radiological Alignment and Incidence of Malunion / Nonunion (n=120)

Malunion defined as angulation greater than 5 degrees was more common in the intramedullary nailing group (15.0%) compared to plate fixation (8.3%), but this difference was not statistically significant (χ² = 1.44, p = 0.231). Nonunion rates beyond 9 months were comparable between groups (6.7% vs. 5.0%, p = 0.692). Quantitative assessment of angular deformities revealed significantly better alignment in the plate fixation group. The mean varus-valgus angulation was 2.4° (SD 1.3) for plating versus 3.1° (SD 1.5) for nailing (t = -3.30, 95% CI: -1.10 to -0.30, p = 0.001). Similarly, anterior-posterior angulation was lower in the plate group at 1.8° (SD 1.1) compared to 2.3° (SD 1.4) in the nailing group (t = -2.62, 95% CI: -0.85 to -0.13, p = 0.010).

The baseline demographic and clinical characteristics of the study population showed no significant differences between the plate fixation and intramedullary nailing groups in terms of age, gender distribution, side of injury, mechanism of injury, or the proportion of open fractures (Table 1). The mean age was approximately 39 years in both groups, consistent with the young, active population commonly affected by tibial shaft fractures as reported by Zhang B et al. (2015)[7] and Minhas SV et al. (2015)[8]. Male predominance was observed, aligning with previous epidemiological studies attributing this to higher risk exposure in males. The majority of injuries were due to road traffic accidents (over 70%), which is similarly documented in other studies from trauma centers worldwide. The comparable rates of Gustilo-Anderson type I and II open fractures across both groups facilitated a balanced comparison without bias from fracture severity. Costa ML et al. (2017)[9]

Regarding fracture healing, the intramedullary nailing group demonstrated significantly shorter times to both clinical and radiological union compared to the plate fixation group (Table 2). The mean time to clinical union was approximately 2 weeks less, and radiological union occurred nearly 2.5 weeks earlier in the nailing group, with p-values <0.01. These findings resonate with several randomized controlled trials and meta-analyses suggesting that IM nailing promotes faster fracture healing due to its biomechanical load-sharing properties and less disruption of the periosteal blood supply compared to plate fixation. Xiao H et al. (2016)[10] Although delayed union was more frequent in the plate group, this difference was not statistically significant, likely reflecting the variability in patient factors and fracture biology. Similar trends were noted by Radaideh A et al. (2022)[11], who found higher union rates and shorter healing times in nailing cohorts.

Functional outcomes measured by the Lower Extremity Functional Scale (LEFS) favored the intramedullary nailing group, with significantly higher scores indicating better limb function (Table 3). This superior functional recovery may be attributed to earlier mobilization and weight-bearing allowed by IM nailing, as supported by previous studies. Yoon RS et al. (2015)[12] Infection rates were low and comparable between groups, though slightly higher superficial infection incidence was seen in plate fixation, likely due to the more invasive nature of open reduction and plating. Implant failure rates were minimal and similar, underscoring the reliability of both fixation methods when applied appropriately. Persistent knee pain was more frequent in the nailing group but did not reach statistical significance, a complication documented in other studies as related to nail entry site morbidity. Allen JD et al. (2018)[13]

Radiological analysis revealed that malunion rates (>5° angulation) and nonunion rates were low and statistically similar between groups (Table 4). However, quantitative measurements showed significantly better angular alignment in the plate fixation group for both varus-valgus and anterior-posterior planes. This aligns with literature indicating that plate fixation offers superior control of fracture alignment due to direct visualization and rigid fixation, whereas IM nailing is susceptible to malalignment, particularly in the coronal plane. Achten J et al. (2015)[14] Despite this, the clinical relevance of minor malalignments remains debated, especially when functional outcomes are preserved. Maredza M et al. (2018)[15]

In this comparative study of plate fixation versus intramedullary nailing for midshaft tibial fractures, intramedullary nailing demonstrated significantly faster fracture union and superior functional outcomes. While plate fixation provided better radiological alignment with less angular deformity, both techniques had comparable complication rates including infection and nonunion. The choice of fixation method should be individualized based on fracture characteristics, patient factors, and surgeon expertise, balancing the benefits of faster healing and functional recovery against the need for anatomical alignment.

1. Hu L, Xiong Y, Mi B, Panayi AC, Zhou W, Liu Y, Liu J, Xue H, Yan C, Abududilibaier A, Chen L. Comparison of intramedullary nailing and plate fixation in distal tibial fractures with metaphyseal damage: a meta-analysis of randomized controlled trials. Journal of orthopaedic surgery and research. 2019 Dec;14:1-1.
2. Yoon RS, Bible J, Marcus MS, Donegan DJ, Bergmann KA, Siebler JC, Mir HR, Liporace FA. Outcomes following combined intramedullary nail and plate fixation for complex tibia fractures: a multi-centre study. Injury. 2015 Jun 1;46(6):1097-101.
3. Behlmer RJ, Whiting PS, Kliethermes SA, Wendt L, Simske NM, Sato EH, Doro CJ, Goodspeed DC, Lang GJ. Reduction techniques for intramedullary nailing of tibial shaft fractures: a comparative study. OTA International. 2021 Mar 1;4(1S):e095.
4. Hussain N, Sermer C, Prusick PJ, Banfield L, Atrey A, Bhandari M. Intramedullary nailing versus plate fixation for the treatment displaced midshaft clavicular fractures: a systematic review and meta-analysis. Scientific reports. 2016 Oct 20;6(1):34912.
5. Ren C, Li M, Sun L, Li Z, Xu Y, Lu Y, Wang Q, Ma T, Xue H, Zhang K. Comparison of intramedullary nailing fixation and percutaneous locked plating fixation for the treatment of proximal tibial fractures: A meta-analysis. Journal of Orthopaedic Surgery. 2021 Jul 6;29(2):23094990211024395.
6. Tas DB, Smeeing DP, Emmink BL, Govaert GA, Hietbrink F, Leenen LP, Houwert RM. Intramedullary fixation versus plate fixation of distal fibular fractures: a systematic review and meta-analysis of randomized controlled trials and observational studies. The Journal of Foot and Ankle Surgery. 2019 Jan 1;58(1):119-26.
7. Zhang B, Zhu Y, Zhang F, Chen W, Tian Y, Zhang Y. Meta-analysis of plate fixation versus intramedullary fixation for the treatment of mid-shaft clavicle fractures. Scandinavian journal of trauma, resuscitation and emergency medicine. 2015 Dec;23:1-1.
8. Minhas SV, Ho BS, Switaj PJ, Ochenjele G, Kadakia AR. A comparison of 30-day complications following plate fixation versus intramedullary nailing of closed extra-articular tibia fractures. Injury. 2015 Apr 1;46(4):734-9.
9. Costa ML, Achten J, Griffin J, Petrou S, Pallister I, Lamb SE, Parsons NR, FixDT Trial Investigators. Effect of locking plate fixation vs intramedullary nail fixation on 6-month disability among adults with displaced fracture of the distal tibia: the UK FixDT randomized clinical trial. Jama. 2017 Nov 14;318(18):1767-76.
10. Xiao H, Gao H, Zheng T, Zhao J, Tian Y. Plate fixation versus intramedullary fixation for midshaft clavicle fractures: meta-analysis of complications and functional outcomes. Journal of International Medical Research. 2016 Apr;44(2):201-15.
11. Radaideh A, Alrawashdeh MA, Al Khateeb AH, Obeidat O, Tabar MA, Essa SM, Alkhatatba MA, Albayati MM, Albashaireh M. Outcomes of treating tibial shaft fractures using intramedullary nailing (IMN) versus minimally invasive percutaneous plate osteosynthesis (MIPPO). Medical Archives. 2022 Feb;76(1):55.
12. Yoon RS, Gage MJ, Donegan DJ, Liporace FA. Intramedullary nailing and adjunct permanent plate fixation in complex tibia fractures. Journal of orthopaedic trauma. 2015 Aug 1;29(8):e277-9.
13. Allen JD, Murr K, Albitar F, Jacobs C, Moghadamian ES, Muchow R. Titanium elastic nailing has superior value to plate fixation of midshaft femur fractures in children 5 to 11 years. Journal of Pediatric Orthopaedics. 2018 Mar 1;38(3):e111-7.
14. Achten J, Parsons NR, McGuinness KR, Petrou S, Lamb SE, Costa ML. UK Fixation of Distal Tibia Fractures (UK FixDT): protocol for a randomised controlled trial of ‘locking’plate fixation versus intramedullary nail fixation in the treatment of adult patients with a displaced fracture of the distal tibia. BMJ open. 2015 Sep 1;5(9):e009162.
15. Maredza M, Petrou S, Dritsaki M, Achten J, Griffin J, Lamb SE, Parsons NR, Costa ML. A comparison of the cost-effectiveness of intramedullary nail fixation and locking plate fixation in the treatment of adult patients with an extra-articular fracture of the distal tibia: economic evaluation based on the FixDT trial. The bone & joint journal. 2018 May 1;100(5):624-33.