Tibial shaft fractures are among most commonly encountered long bone injuries in orthopaedic trauma, constituting roughly 1% to 2% of all fractures in adults as well as 36–43% long bone fractures【1】. These injuries frequently affect young, economically productive males and are often the result of high-energy trauma such as RTAs(road traffic accidents), drops from a height, or industrial accidents【2】. The tibia’s anteromedial subcutaneous position and relatively poor vascularity make it particularly prone to open fractures, delayed healing, and problems including nonunion as well as infection【3】.

Intramedullary interlocking nailing (IM nailing) is widely acknowledged as the preferred treatment for displaced tibial shaft fractures, offering biomechanical stability, preservation of soft tissue integrity, and the potential for early weight-bearing【4】. The load-sharing nature of the nail and its central placement along the tibial axis promote biological healing while minimising soft tissue disruption【5】. However, complications such as anterior knee pain, malalignment, delayed union, and hardware irritation remain concerns, especially in fractures involving the proximal or distal third【6,7】.

In high-income countries, access to advanced diagnostic modalities (e.g., CT, MRI), specialised implants, and structured physiotherapy protocols has improved outcomes significantly. Conversely, in low-resource settings such as rural and semi-urban India, patients often face delayed presentation, inadequate rehabilitation, and financial barriers that compromise long-term recovery【8,9】.

Furthermore, follow-up compliance is frequently poor due to socioeconomic constraints, making mid-term outcome assessment more relevant in such contexts【10】.

Although numerous studies have evaluated the efficacy of IM nailing, most originate from high-income countries with optimal care delivery systems【4,5】. Indian data on functional and radiological outcomes in low-resource settings remain scarce. Moreover, lifestyle factors such as frequent squatting, cross-legged sitting, and the need for early return to physical labour in the Indian population further emphasise the need for context-specific outcome assessments【11】.

This study has been undertaken to evaluate radiological as well as functional results of intramedullary interlocking nailing in tibial shaft fractures over 6 months in resource-limited tertiary care hospital. Standardised, validated scoring systems—including the RUST(Radiographic Union Score for Tibia), Lysholm Knee Score (LKS), AOFAS Ankle-Hindfoot Score, as well as VAS(Visual Analog Scale) for pain—have been used to provide a comprehensive and objective assessment. The results aim to bridge the evidence gap and inform best practices in settings with limited infrastructure and economic constraints.

This prospective observational research has been conducted at Department of Orthopaedics in tertiary care teaching hospital located in North India, catering primarily to patients from low-income and semi-urban backgrounds. The study spanned from March 2023 to June 2025, with all participants followed for minimum 6 months postoperatively.

Inclusion and Exclusion Criteria: Patients aged 18 years and above with radiologically confirmed tibial shaft fractures were considered eligible. Inclusion criteria comprised fractures classified as AO/OTA Type 42A-C2 as well as open fractures of Gustilo-Anderson Grade I–IIIA managed with intramedullary interlocking (IM) nailing. Exclusion criteria included Gustilo Grade IIIB/IIIC open fractures, AO Type 42C3 fractures, neurovascular injury, medical unfitness for surgery, and inability to complete the 6-month follow-up.

Sample Size: Based on previous studies with an assumed standard deviation of 10 and a margin of error of 3.58 at a 95% confidence level, a minimum sample size of 30 was calculated. A consecutive sampling method was used, and all eligible patients presenting during the study period were enrolled.

Surgical Technique : All procedures were performed under spinal anaesthesia using a standard infrapatellar approach. A midline skin incision and paratendinous entry portal were used to access the medullary canal. Closed reduction under fluoroscopic guidance was attempted in all cases, with mini-open reduction used as needed.

Reaming was performed in 83.3% of patients using flexible reamers 1–1.5mm larger than nail diameter. Solid stainless-steel nails were inserted as well as locked proximally additionally distally using static or dynamic locking screws. Nail lengths ranged from 280 to 360 mm, with diameters of 9–11 mm. All wounds were irrigated and closed in layers with appropriate sterile dressings.

Postoperative Protocol: Early mobilisation was initiated on the first postoperative day with ankle pumps and quadriceps strengthening. Non-weight-bearing ambulation began within 2–3 days, progressing to partial as well as full weight-bearing by 6 to 12weeks, depending on fracture type and stability.

Follow-Up and Outcome Measures: Follow-up was conducted at 15 days, 1, 3, as well as 6 months postoperatively. At each visit, clinical evaluation involved pain assessment via VAS, range of motion, gait, along with complications. Functional outcomes were assessed using:

Lysholm Knee Score (LKS) – for knee function

AOFAS Ankle-Hindfoot Score – for ankle function

Modified Johner and Wruhs (MJW) Score – for overall limb function

VAS Pain Score – for subjective pain evaluation

Radiological assessment encompassed anteroposterior as well as lateral radiographs at each visit. Fracture healing was quantified utilizing RUST(Radiographic Union Score for Tibia), with scores ≥9 considered indicative of union.

Data Collection and Statistical Analysis:  Data were collected using a pre-structured proforma and analysed using SPSS v25.0 (IBM Corp., NY, Armonk). Continuous variables had been expressed as mean ± standard deviation. Paired t-tests as well as Wilcoxon signed-rank tests were used for functional score progression. Categorical variables were analysed using chi-square or Fisher's exact tests. Pearson correlation has been applied to evaluate associations among radiological and functional outcomes. A p-value <0.05 has been considered statistically significant.

Ethical Considerations: Study received consent from Institutional Ethics Committee. Written informed consent has been obtained from every participant. Patient secrecy was strictly maintained, along with no financial incentives being provided.

Patient Demographics and Injury Profile

A total 30 patients had been included, with a mean age 39.1 ± 13.9 years (range 18–67 years). There was a male predominance (n = 23, 76.7%). Most patients (43.3%) were unskilled labourers. Hypertension (16.7%) as well as diabetes mellitus (13.3%) have been most common comorbidities. A significant proportion of patients were smokers (36.7%) or alcohol users (26.7%).

Table 1. Demographic and Injury Characteristics This table summarises baseline patient demographics, comorbidities, and fracture-related variables.

The majority of injuries were caused by road traffic accidents (60.0%), followed by falls from height (23.3%). High-energy trauma accounted for 66.7% of cases. The right leg was involved in 66.7% of patients. The most frequent fracture location was middle third of tibia (36.7%). One-third of cases were open fractures, having most being Gustilo Grade I or II.

Surgical Profile

Table 2: Surgery Details Details of the operative technique, implant parameters, and intraoperative measures.

All patients underwent intramedullary interlocking nailing, predominantly using reamed technique (83.3%). The most commonly used nail dimensions were 320mm in length as well as 9mm in diameter. Static locking having 2 proximal along with 2 distal screws was most frequent configuration (56.7%). Mean surgical time was 95.2 ± 13.4 minutes, and average blood loss was 73.5 ± 20.6 mL. All procedures were performed under spinal anaesthesia.

Radiological Outcomes

Table 4. Radiological Union Outcome Time to union and union status based on RUST scoring system.

Radiological union (RUST score ≥10) was observed in 27 patients (90.0%) by 6 months. Mean RUST score improved progressively across follow-ups:

Mean time to radiological union has been 16.9 ± 2.8 weeks, as well as clinical union has been achieved at 15.8 ± 2.5 weeks. Delayed union occurred in 2 cases (6.7%), and 1 patient (3.3%) had nonunion.

Functional Outcomes

Table 3: Mean Functional Scores at Each Follow-Up Progression of validated functional scores across follow-up periods.

Functional scores showed significant improvement at each follow-up (p < 0.001):

Lysholm Knee Score: from 45.5 ± 6.7 at 15 days to 87.1 ± 5.0 at 6 months

AOFAS Score: from 34.3 ± 7.6 to 87.3 ± 6.1

VAS Pain Score: declined from 5.1 ± 0.8 to 1.3 ± 0.9 At 6 months,

83.3% of patients had excellent outcomes per the Modified Johner and Wruhs (MJW) score, 13.3% had good results, as well as 3.3% had fair results.

Factors Influencing Union and Function

Table 5: Correlation of RUST Score with Functional Scores at 6 Months Strength and significance of the association between radiological and functional outcomes.

Patients with open fractures had longer mean union times (17.8 versus 15.9 weeks, p = 0.040). Reamed nailing resulted in significantly faster union than unreamed technique (15.8 vs 18.2 weeks, p = 0.030). Smoking (p = 0.020) as well as diabetes (p = 0.050) have been associated with delayed union.

RUST scores at 6 months strongly correlated with: Lysholm Score (r=0.84, p<0.001), AOFAS Score (r=0.85, p<0.001), VAS Score (r=–0.73, p<0.001), MJW Score (r=–0.87, p<0.001)

Complications

Table 6. Complications and Adverse Events Frequency and type of complications observed during the 6-month follow-up.

The overall complication rate was low.

Anterior knee pain: 3 patients (10.0%), Hardware irritation: 6 patients (20.0%), Superficial infection: 1 case (3.3%), Malalignment: 2 cases (6.7%), Nonunion: 1 patient (3.3%), Delayed union: 2 patients (6.7%)

Reoperations were performed in 3 cases: 1 for bone grafting and 2 for symptomatic hardware removal. Patients having complications had significantly worse functional results (p-value < 0.05).

Graph 1- Progression of Mean RUST Score Over Follow-Up Periods in Tibial Shaft Fractures.

The shaded area represents the standard deviation

Graph 2 - Functional Score Over Follow-Up

Graph 3: Correlation between Radiographic Union Score for Tibia (RUST) and functional outcome scores at 6 months.

This prospective observational study evaluated the functional and radiological outcomes of intramedullary interlocking nailing (IM nailing) for tibial shaft fractures in a resource-constrained tertiary care setting. The results reaffirm that IM nailing is a reliable treatment modality, even in economically limited environments, having high union rates, significant functional improvement, as well as a low complication profile.

In our cohort, mean age of patients has been 39.1yrs, with male predominance (76.7%), consistent with global epidemiological trends that attribute high tibial fracture incidence to road traffic accidents among young males【12】. The mid-diaphyseal region was the most common fracture location, likely due to its relative anatomical vulnerability and poor vascularity【13】.

Radiological union has been achieved in 90% patients within mean of 16.9weeks, which aligns with union rates (85–95%) reported in previous studies on IM nailing【14,15】. The use of RUST allowed objective quantification of healing, as well as correlated strongly with functional outcomes, particularly the Lysholm and AOFAS scores. This correlation supports existing literature validating RUST as a reliable predictor of both radiographic and clinical recovery【16,17】.

Functionally, 83.3% of patients achieved excellent results per the Modified Johner and Wruhs (MJW) score at 6 months. These outcomes are comparable to research by Im et al. and Vallier et al., which showed satisfactory knee as well as ankle function following timely mobilisation and stable fixation【18,19】. The early initiation of rehabilitation, made feasible by the stability of IM nailing, was likely a key contributor to these results.

Notably, anterior knee pain occurred in 10% of patients, lower than the rates (up to 30%) reported in other series【20】. The infrapatellar entry portal and careful implant selection may have helped minimise this complication. Hardware irritation at the distal screws, however, was the most frequent complaint (20%), which resolved with elective removal in some cases.

Delayed union (6.7%) and nonunion (3.3%) rates were low. Risk factors such as diabetes, smoking, and open fractures were associated with prolonged healing—findings echoed in earlier studies by Keating et al. and Giannoudis et al.【21,22】. Reamed nails were associated with faster union compared to unreamed techniques, supporting conclusions from the SPRINT trial and other meta-analyses favouring reaming in closed fractures【23】.

Importantly, the study context—serving a low-income, rural-urban mixed population—makes the findings highly applicable to similar resource-constrained environments. Radiographs were the sole imaging modality available for assessment, and physiotherapy resources were limited. Despite these limitations, standardised outcome scores and consistent follow-up yielded results comparable to higher-income settings.

Limitations of this research include the small sample size as well as short follow-up period (6 months). While early functional and radiological outcomes were favourable, long-term complications, including chronic anterior knee pain, implant failure, as well as return to work or sports, were not assessed. Additionally, the absence of a comparison group (e.g., plating or external fixation) limits broader conclusions about treatment superiority.

Overall, IM nailing remains a robust technique for managing tibial shaft fractures, even when resources are limited. By adhering to standard surgical principles and employing objective outcome measures like the RUST, Lysholm, and AOFAS scores, clinicians in low-resource settings can achieve results comparable to global benchmarks.

Intramedullary interlocking nailing is an effective as well as reliable method for management of tibial shaft fractures, even in resource-constrained healthcare settings. This study demonstrated high rates of radiological union (90%) and excellent functional recovery in majority of patients within 6-month follow-up period. The use of reamed nailing, adherence to standard surgical principles, and early initiation of rehabilitation were associated with better outcomes.

The Radiographic Union Score for Tibia (RUST) correlated strongly with validated functional result scores, including Lysholm Knee Score as well as AOFAS Ankle-Hindfoot Score, reinforcing its utility as a simple, reproducible tool in routine follow-up. Although minor complications, including anterior knee pain as well as hardware irritation, had been noted, the overall complication rate remained low.

These results support continued usage of intramedullary nailing as standard of care for diaphyseal tibial fractures in low-resource environments. With proper technique and structured follow-up, comparable results to high-income settings can be achieved, thereby improving patient outcomes and reducing long-term disability in economically vulnerable populations.

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