Tibial shaft fractures are among the most frequently encountered long-bone injuries and represent an important cause of disability in young and economically active adults. Their clinical importance reflects both the frequency of injury and the distinctive anatomy of the tibia. Much of the anteromedial tibial surface is subcutaneous, soft-tissue coverage is relatively limited, and high-energy injuries may be accompanied by substantial soft-tissue damage, open wounds, compartment syndrome, malalignment, delayed union, and nonunion.[1-4] Epidemiological studies consistently demonstrate a predominance of tibial shaft fractures in younger men after high-energy trauma, although low-energy injuries also occur in older adults.[5]

Locked intramedullary nailing has become the preferred operative treatment for most displaced tibial shaft fractures because it provides load-sharing fixation while preserving fracture biology and permitting relatively early mobilization.[6] Successful intramedullary nailing, however, depends on accurate entry point selection, maintenance of reduction during guidewire passage and reaming, appropriate nail trajectory, and stable interlocking. Malposition of the starting point or difficulty controlling the proximal fragment may lead to angular deformity, particularly valgus or procurvatum in proximal and metaphyseal fractures.[7]

The conventional infrapatellar nailing technique is performed with the knee flexed, commonly to approximately 90° or more. Although familiar to most surgeons and technically reliable in many diaphyseal fractures, this position can create several problems. Knee hyperflexion increases the deforming effect of the quadriceps mechanism on the proximal tibial fragment, tending to produce apex-anterior angulation. Maintaining reduction while simultaneously obtaining satisfactory anteroposterior and lateral fluoroscopic views can be difficult. Repeated limb manipulation may increase operative and fluoroscopy time, and swelling or soft-tissue compromise may further complicate positioning.[8,9]

Anterior knee pain is another important concern after traditional tibial nailing. Published series have reported a wide range of postoperative anterior knee pain following infrapatellar nail insertion, and the symptoms may persist despite radiographic union.[10,11] The exact mechanism is multifactorial and may include injury to the patellar tendon, infrapatellar branch of the saphenous nerve, Hoffa fat pad, retropatellar tissues, prominence of the nail, or local scar sensitivity. Because patients with tibial shaft fractures are often young, even modest persistent knee symptoms can have substantial effects on kneeling, squatting, work, sports participation, and overall satisfaction.

Suprapatellar nailing was developed as an alternative method in which the nail is introduced through a retropatellar portal with the knee maintained in a semiextended position, usually around 15°-30° of flexion.[12] The reduced flexion neutralizes the quadriceps-related deforming force and allows the leg to rest in a relatively stable position throughout reduction, guidewire placement, reaming, and nail insertion. This configuration may improve fluoroscopic access and facilitate maintenance of alignment, particularly in proximal and distal third fractures.[13,14] Modern suprapatellar systems use a protective cannula or sleeve to shield the patellofemoral cartilage and surrounding soft tissues while instruments pass into the proximal tibia.

The approach is nevertheless not without theoretical disadvantages. Because instrumentation traverses the patellofemoral joint, there has been concern regarding iatrogenic chondral injury, intra-articular debris, and septic arthritis in contaminated fractures.[15] Cadaveric and clinical studies have therefore examined contact pressures, cartilage injury, postoperative imaging, and knee symptoms. Available evidence generally suggests that, when a dedicated protective sleeve is correctly used, clinically important patellofemoral damage is uncommon, although careful technique remains essential.[16,17]

Comparative studies and meta-analyses increasingly favour suprapatellar nailing for several perioperative and functional outcomes. Suprapatellar techniques have been associated with more accurate nail entry, reduced malalignment, shorter operative or fluoroscopy time, and less postoperative anterior knee pain in several cohorts.[18-22] Some randomized and prospective studies have also reported superior Lysholm or other knee-specific functional scores after suprapatellar nailing. At the same time, not all studies demonstrate differences in union, range of motion, general health status, or complications, and variation in fracture location, implant systems, follow-up duration, and surgeon experience complicates interpretation.

The question is particularly relevant in high-volume trauma practice, where efficiency of reduction and imaging, reproducibility of technique, and early functional rehabilitation are important. A comparison that incorporates both surgical variables and patient-centred clinical outcomes can clarify whether the theoretical advantages of the semiextended suprapatellar approach translate into meaningful benefit.

The present study therefore compared suprapatellar and infrapatellar intramedullary nailing in adults with tibial shaft fractures treated at a tertiary government hospital. The primary objectives were to compare postoperative knee ROM, Lysholm knee score, and lower-extremity functional outcome. Secondary objectives included comparison of operative time, blood loss, hospital stay, clinical union, and complications. We hypothesized that suprapatellar nailing would reduce operative burden and improve postoperative functional outcomes without adversely affecting fracture union or knee motion.

Study design and setting A hospital-based prospective, interventional, randomized comparative study was conducted in the Department of Orthopaedics, Dr Rajendra Gode Medical College and Hospital, Amravati, Maharashtra, India. The planned study duration was 18 months. The study compared two accepted intramedullary nailing approaches for tibial shaft fractures: suprapatellar nailing (SPN) and infrapatellar nailing (IPN). Participants Adults older than 18 years presenting to the orthopaedic outpatient or inpatient services with tibial shaft fractures requiring intramedullary nailing were screened. Eligible fractures were closed, displaced, and extra-articular. Associated fibular fracture was permitted. Both male and female patients were eligible. Patients were excluded if they had polytrauma requiring combined management, paediatric fractures, active infection at the fracture site, refracture with an implant in situ, an associated intra-articular fracture, proximal tibial fracture, or segmental tibial fracture. Written informed consent was obtained before enrolment. Sample-size calculation The sample size was calculated using operative time reported by Al-Azzawi et al., in whom mean operative time was approximately 139±24.5 minutes for IPN and 110±34.2 minutes for SPN.[21] With 80% power and a two-sided alpha of 5%, the minimum calculated sample size was 17 participants per group. To accommodate possible attrition and improve precision, 20 participants were recruited into each group, giving a final study sample of 40. Randomization Participants were allocated in a 1:1 ratio to SPN or IPN. Computerized randomization was performed using a random-number function generating either 1 or 2. A generated value of 1 corresponded to SPN and 2 to IPN. The final groups therefore consisted of 20 patients each. Preoperative assessment A detailed history and clinical examination were recorded using the study proforma. Demographic characteristics, mode of injury, fracture laterality, associated medical conditions, and American Society of Anesthesiologists (ASA) grade were documented. Radiographs were reviewed to confirm fracture location and pattern, and fractures were categorized according to the AO/OTA framework. Routine preoperative investigations and anaesthetic assessment were performed according to institutional protocol. Antibiotic prophylaxis was administered at induction. Surgical technique All operations were performed by senior orthopaedic consultants using standardized operative principles. For SPN, the patient was positioned supine with the knee in approximately 20° of flexion. A midline incision was made proximal to the superior pole of the patella and the quadriceps tendon was split in line with its fibres. A dedicated trocar and protective sleeve were advanced through the patellofemoral articulation to the proximal tibial entry point. The starting point and guidewire position were confirmed fluoroscopically in anteroposterior and lateral views. Reaming and nail insertion were then performed through the protective sleeve, followed by proximal and distal interlocking. For IPN, the patient was positioned supine with the knee flexed according to the standard infrapatellar technique. The entry point was obtained through the conventional infrapatellar region, followed by guidewire placement, reduction, reaming, nail insertion, and interlocking. In both groups, care was taken to obtain an anatomically appropriate starting point and satisfactory coronal and sagittal alignment. Operative and radiographic variables Operative duration was recorded, including positioning and fracture reduction. Estimated surgical blood loss was documented. The study protocol also recorded fluoroscopy time and radiation dose, although these variables were not presented in the final comparative results tables and therefore were not included as primary manuscript outcomes. Immediate postoperative radiographs were used to assess nail entry and alignment. The optimum anteroposterior entry point was defined in the study protocol relative to the lateral tibial spine. Postoperative care and follow-up Patients received routine postoperative wound care, analgesia, thromboprophylaxis when indicated, and physiotherapy according to institutional practice. Follow-up visits were scheduled at 2, 4, 12, and 24 weeks. Clinical evaluation was performed at each visit. Postoperative radiographs were obtained routinely and at approximately 3 months, with additional imaging when clinically indicated. Outcome measures The primary outcomes were postoperative knee ROM, Lysholm knee score, and Lower Extremity Functional Scale (LEFS). The Lysholm score is a knee-specific functional instrument in which higher values indicate better function.[23] LEFS was used to quantify lower-limb functional ability. In the study, scores of 70-80 were categorized as excellent, 60-70 as good, 40-60 as fair, and <40 as poor. Secondary outcomes included operative time, blood loss, length of hospital stay, time to clinical union, and complications. Clinical union was assessed during follow-up using clinical and radiographic findings according to the study protocol. Complications specifically reported in the results included malalignment and superficial infection. Statistical analysis Quantitative variables were summarized as mean±standard deviation and categorical variables as frequency and percentage. Between-group comparisons for continuous outcomes were performed using an unpaired Student t test. Categorical variables were compared using chi-square or Fisher exact tests as appropriate. A two-sided p value <0.05 was considered statistically significant. Analysis was performed using SPSS version 20 and Microsoft Excel. The original study tables contain typographical inconsistencies in the p-value entries for mean LEFS and mean Lysholm score: the narrative describes these differences as significant, while the tabulated p value is shown as >0.05. For manuscript preparation, the p values were recalculated from the reported group means, standard deviations, and n=20 per group. Both differences are highly significant (LEFS p<0.001; Lysholm p<0.001), consistent with the direction and interpretation given in the study discussion. Ethical considerations Institutional Ethics Committee approval was obtained before recruitment. Participants were informed about both surgical techniques, study procedures, potential risks and benefits, confidentiality, and the right to withdraw without affecting clinical care. Written informed consent was obtained from all participants. The exact IEC approval number and approval date should be inserted from the institutional ethics record before journal submission.

Forty patients were randomized equally to SPN and IPN, with 20 participants in each group. The mean age was 38.05±17.29 years in the SPN group and 37.65±17.29 years in the IPN group. The largest age category in both groups was 18-30 years. Men constituted 70% of the SPN group and 80% of the IPN group. Right-sided fractures predominated (65% vs 80%). Most patients were ASA grade I. Road-traffic accidents were the most common mechanism of injury, followed by falls from height and sports injuries. Although the SPN group contained a higher proportion of complex fracture patterns (50% vs 25%), baseline differences in age, sex, laterality, ASA grade, fracture pattern, and mechanism of injury were not statistically significant (Table 1).

The suprapatellar approach substantially reduced operative time. Mean duration of surgery was 109.55±15.26 minutes in the SPN group compared with 145.15±28.28 minutes in the IPN group. Recalculation from the reported summary statistics gives p<0.001. Mean blood loss was also lower with SPN (42.45±7.07 mL) than IPN (63.45±8.02 mL; p<0.001). Mean hospital stay was 6.15±1.53 days after SPN and 7.25±2.05 days after IPN; this difference was not statistically significant (Table 2).

Clinical union occurred at a mean of 13.25±4.34 weeks after SPN and 14.85±4.45 weeks after IPN (p>0.05). In the SPN group, 2 patients (10%) achieved clinical union within 7 weeks, 10 (50%) between 7 and 14 weeks, and 8 (40%) between 14 and 21 weeks. The corresponding proportions in the IPN group were 5%, 35%, and 60%. Thus, there was a numerical trend toward earlier union with SPN, but the difference in mean union time was not statistically significant. Postoperative knee ROM was similarly comparable: 115.35±10.44° for SPN and 113.25±9.68° for IPN (p>0.05) (Table 3).

Functional outcomes favoured SPN. Mean LEFS was 75.55±3.22 in the SPN group and 70.65±4.33 in the IPN group. Based on recalculation from the reported summary data, this difference was statistically significant (p<0.001). All 20 patients in the SPN group were categorized as having an excellent lower-extremity functional outcome. In the IPN group, 13 (65%) had an excellent outcome and 7 (35%) had a good outcome. No patient in either group was categorized as fair or poor. The Lysholm knee score showed an even larger between-group difference: 91.05±4.62 after SPN versus 74.90±7.92 after IPN (recalculated p<0.001) (Table 4).

Malalignment was reported in 1 of 20 SPN patients (5%) compared with 4 of 20 IPN patients (20%). The study reports this comparison as statistically significant. One superficial infection occurred in the SPN group and none in the IPN group. No additional major complications were presented in the final results table (Table 5).

Table 1. Baseline characteristics of the study groups

*Overall p value for categorical distribution.

Table 2. Perioperative outcomes

†Recalculated from the reported means, SDs and n=20 per group; source study reports p<0.05.

Table 3. Fracture union and postoperative knee motion

*Overall p value for clinical-union category distribution.

Table 4. Functional outcomes

†Recalculated from reported summary statistics because the source study table contains an internal p-value inconsistency. *Overall p value for LEFS category distribution.

Table 5. Reported postoperative complications

This randomized comparative study found that suprapatellar tibial nailing provided several perioperative and functional advantages over the conventional infrapatellar technique. The SPN group had shorter surgery, lower blood loss, better LEFS and Lysholm scores, and fewer cases of malalignment. In contrast, hospital stay, time to clinical union, and knee ROM were similar. These findings suggest that the principal benefit of the suprapatellar technique may be improved procedural efficiency, maintenance of alignment, and patient-reported knee and lower-limb function rather than acceleration of biological fracture healing. The study population was typical of tibial shaft fracture cohorts, with a predominance of young adults and men. Road-traffic accidents were the leading mechanism of injury. Larsen et al. similarly described tibial shaft fractures as an injury occurring frequently in younger males and related to higher-energy mechanisms.[5] Importantly, the randomized groups in the present study were broadly comparable in age, sex, laterality, ASA grade, mechanism, and fracture pattern. The SPN group actually contained more complex fractures numerically, yet operative and functional outcomes remained favourable. Although the small sample prevents definitive adjustment for fracture complexity, this pattern reduces concern that the results simply reflect a less demanding fracture mix in the SPN group. Operative time was one of the clearest differences. SPN shortened the mean operation by approximately 36 minutes. This is consistent with the study by Al-Azzawi et al., which formed the basis of the sample-size calculation and reported mean operative times of approximately 110 minutes for SPN and 139 minutes for IPN.[21] Sahni et al. likewise reported shorter mean surgical time with SPN, and Umur et al. found a substantial reduction in operative duration with the suprapatellar technique.[22,24] The probable explanation is mechanical and logistical. With the knee semiextended, the limb can be maintained in a stable position while reduction, fluoroscopy, guidewire passage, reaming, and nail insertion are performed. In the infrapatellar approach, repeated transitions between flexion for entry and manipulation for imaging may prolong the procedure. Reduction of operative duration is clinically relevant beyond operating-room efficiency. Longer procedures can increase anaesthetic exposure, soft-tissue handling, infection risk, and resource consumption. In busy trauma services, a reproducible approach that simplifies positioning may also reduce variability among surgeons and theatre teams. However, operative time is influenced by surgeon familiarity, fracture complexity, implant design, and the learning curve. Because the study was conducted at a single centre and all operations were performed by experienced consultants, the magnitude of the time difference may not be identical in other settings. Blood loss was also significantly lower with SPN, by approximately 21 mL on average. The absolute volume was small in both groups and is unlikely to determine transfusion need in most isolated tibial fractures, but the finding was consistent with prior comparative data. Sahni et al. reported mean blood loss of approximately 49 mL with SPN and 62 mL with IPN, while Vishnu et al. also observed lower blood loss with SPN.[22,25] The difference may reflect shorter operative duration and less repeated manipulation. Although statistically robust, its direct clinical importance should therefore be interpreted as modest. Hospital stay did not differ significantly. This is expected because discharge after tibial nailing depends on pain control, wound condition, mobility with assistance, associated injuries, social circumstances, and local practice. The mean stay was numerically about one day shorter after SPN but the study was not powered specifically for length of stay. Similar observations have been reported in other comparative series.[25] Clinical union occurred at approximately 13 weeks after SPN and 15 weeks after IPN, without a statistically significant difference. This is important because the surgical approach to the proximal tibial entry point should not be expected to have a major direct effect on fracture biology at the diaphyseal injury site. Both techniques use the same central principle of intramedullary load-sharing fixation, and union is influenced primarily by fracture pattern, soft-tissue injury, smoking, infection, stability, reaming strategy, and patient biology. Sahni et al. and Vishnu et al. likewise found broadly comparable union times between approaches.[22,25] The present data therefore support the view that the advantage of SPN is technical rather than biological. Postoperative knee ROM was also similar. Mean flexion exceeded 110° in both groups and differed by only about 2°. This finding is consistent with reports that both approaches can preserve satisfactory knee motion when rehabilitation is appropriately performed. It also suggests that passage through the suprapatellar portal did not produce a clinically important restriction of motion during the study period. ROM, however, is a relatively coarse outcome and does not capture pain during kneeling, stair climbing, squatting, or high-demand activity. The patient-reported functional findings were more distinctive. LEFS was approximately five points higher with SPN, and all SPN patients fell into the study defined excellent category. More strikingly, mean Lysholm score was about 16 points higher after SPN. Al-Azzawi et al. also reported a higher Lysholm score with SPN, approximately 90 compared with 75 for IPN, which is closely aligned with the present results.[21] Umur et al. demonstrated superior Lysholm scores and substantially less anterior knee pain in the suprapatellar group.[24] More recently, van de Pol et al. reported better patellofemoral function and lower anterior knee pain after suprapatellar nailing in a randomized trial.[26] A likely explanation is avoidance of direct injury and scarring in the infrapatellar tendon region combined with the more stable semiextended operative position. Postoperative anterior knee pain after tibial nailing is multifactorial and may arise from the patellar tendon, infrapatellar nerve, nail prominence, fat-pad injury, or local scar. Although the present study did not tabulate VAS pain as a final outcome, the difference in Lysholm score may capture consequences of pain, instability, and activity limitation. Future studies should directly measure anterior knee pain with a standardized pain scale alongside validated knee-specific patient-reported outcomes. The potential trade-off is that suprapatellar instrumentation traverses the patellofemoral joint. Concern about cartilage injury has been one of the principal criticisms of the technique. Dedicated protective sleeves are therefore essential. Cadaveric and clinical studies have generally found that careful use of modern instrumentation limits contact pressure and chondral injury, although isolated cartilage changes have been described.[16,17,24] The present study reported no clinically evident patellofemoral complication, but it did not include routine postoperative arthroscopy or MRI to detect subclinical cartilage injury. Consequently, the absence of symptoms cannot be equated with proof of absence of articular damage. Malalignment was less frequent after SPN. The semiextended position provides a clear biomechanical explanation: it reduces the quadriceps-driven apex-anterior deforming force that becomes prominent when the knee is hyperflexed and can simplify fluoroscopic assessment of the mechanical axis. Avilucea et al. reported a lower rate of malalignment with suprapatellar nailing for distal tibia fractures, and Metcalf et al. found an independent association between suprapatellar entry and lower malunion risk.[18,20] Systematic reviews have similarly suggested a radiographic advantage for SPN in proximal and distal fractures.[19,27] This may be the most important technical rationale for the approach, particularly where controlling a short metaphyseal segment is difficult. The reported malalignment comparison in the study should nevertheless be interpreted cautiously. With only one event in the SPN group and four in the IPN group, a small change in event count materially affects the p value. Moreover, the study does not provide detailed angular measurements or define the precise malalignment threshold in the final table. For publication, the raw radiographs or master chart should ideally be re-reviewed and malalignment defined prospectively in degrees for coronal and sagittal planes. This would strengthen the manuscript and avoid overstatement of a result derived from few events. Only one superficial infection was recorded, in the SPN group. No deep infection or septic arthritis was reported. This finding is reassuring but cannot establish equivalence for infection risk because the sample is too small for rare complications. Theoretical concern regarding knee sepsis is greatest in open tibial fractures because the suprapatellar portal communicates with the knee joint. The present study included closed displaced fractures, which reduces that concern and limits generalizability to open injuries. One of the strengths of the study is randomized allocation. Many published comparisons are retrospective and therefore susceptible to selection bias, particularly because surgeons may preferentially choose SPN for proximal or distal fractures that are inherently more difficult to control. Randomization helps reduce this bias. The study also assessed several domains: perioperative variables, union, ROM, lower-extremity function, knee-specific function, and complications. This multidimensional assessment is valuable because a technically efficient operation is only clinically meaningful if it does not compromise healing and produces acceptable function. The study also has important limitations. The sample was small, with only 20 participants per group. This limits precision and makes the study underpowered for infrequent complications. Follow-up was approximately six months in the protocol, which may be adequate for union and early function but is insufficient to evaluate late anterior knee pain, patellofemoral degeneration, hardware symptoms, reoperation, or long-term return to sport. The study was conducted at a single institution, so results may reflect local surgical expertise and rehabilitation practice. Blinding was not feasible for surgeons and was not described for outcome assessors. Patient awareness of the incision and technique could influence self-reported outcomes. In addition, the study protocol mentions fluoroscopy duration and radiation dose, but the final results section does not present those data. Because one proposed advantage of SPN is easier fluoroscopic imaging, inclusion of complete radiation data would have strengthened the analysis. If these variables are available in the master chart, they should be added in a revised manuscript. Another limitation is internal inconsistency in the study p-value reporting for LEFS and Lysholm scores. The tables display p>0.05 despite the narrative repeatedly describing statistically significant differences. Recalculation from the published group summary statistics yields highly significant differences for both outcomes, supporting the narrative interpretation. For scientific transparency, the manuscript therefore uses recalculated p values and should retain a note in the statistical working file documenting this correction. Before submission, the original dataset should ideally be reanalysed to confirm all reported p values, particularly the malalignment comparison. The clinical implications are straightforward. SPN appears particularly attractive when fracture reduction is difficult to maintain in flexion, when repeated fluoroscopic repositioning is problematic, or when the fracture lies near the proximal or distal metaphyseal transition. The approach may also be preferable in patients for whom postoperative anterior knee symptoms would be especially limiting. However, surgeon training, availability of a dedicated protective cannula system, sterile technique, and strict attention to the intra-articular pathway are mandatory. The infrapatellar technique remains an established and effective method and should not be considered obsolete. It is familiar, does not pass through the patellofemoral articulation, and may be entirely appropriate for straightforward midshaft fractures in experienced hands. The choice of approach should therefore reflect fracture morphology, surgeon expertise, instrumentation, soft-tissue condition, and patient-specific considerations rather than a rigid rule. Overall, the present findings agree with the direction of contemporary evidence: suprapatellar nailing facilitates semiextended reduction and tends to improve operative efficiency, alignment, and knee-related functional outcomes while providing union and ROM comparable to infrapatellar nailing. Larger multicentre randomized trials with longer follow-up and standardized reporting of anterior knee pain, malalignment, fluoroscopy dose, cartilage outcomes, and return to work are needed to define the magnitude and durability of these benefits. Strengths and Limitations The principal strengths were prospective randomized allocation, standardized surgical management at a single centre, and simultaneous evaluation of perioperative, fracture-healing, knee-motion, functional, and complication outcomes. The study addresses a clinically relevant technical question and its major findings are directionally consistent with contemporary comparative literature. Limitations include the modest sample size, single-centre design, short-to-intermediate follow-up, lack of assessor blinding, and limited power for uncommon adverse events. Fluoroscopy duration and radiation exposure were described in the protocol but not presented in the final results. Routine advanced imaging was not used to assess patellofemoral cartilage. The source study also contained p-value inconsistencies for LEFS and Lysholm scores; these were recalculated from the reported summary statistics for manuscript preparation. Reanalysis of the patient-level dataset is recommended before final journal submission.

Suprapatellar intramedullary nailing in the semiextended position was associated with shorter operative time, lower blood loss, higher LEFS and Lysholm scores, and fewer observed malalignment events than conventional infrapatellar nailing in adults with closed displaced extra-articular tibial shaft fractures. Time to clinical union, postoperative knee ROM, and duration of hospital stay were comparable.

These results support SPN as an effective alternative to the infrapatellar approach, particularly when maintaining fracture reduction and efficient fluoroscopic access are important. The technique should be performed with dedicated protective instrumentation and careful attention to the patellofemoral joint. Larger studies with longer follow-up are required to establish long-term differences in anterior knee pain, cartilage health, malunion, and reoperation.

Declarations

Ethics approval and consent to participate: Institutional Ethics Committee approval was obtained before recruitment, and written informed consent was obtained from all participants.

Consent for publication: The manuscript reports de-identified aggregate clinical data.

Funding: No external funding was reported in the study.

Conflicts of interest: To be declared by all authors before submission.

Data availability: De-identified study data may be made available by the corresponding author subject to institutional and ethics requirements.

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