Comparison of Radiological and Functional Outcomes in Pediatric Diaphyseal Femoral Fractures Managed With Titanium Elastic Nail versus Submuscular Compression Plates at Tertiary Care Hospital

This single-centre, parallel-group randomized controlled trial was conducted in the Department of Orthopaedic Surgery, Civil Hospital Karachi, 25 June, 2025 to 10 November 2025. The research synopsis was approved by the Research Evaluation Unit of the College of Physicians and Surgeons Pakistan under reference number CPSP/REU/OSG-2024-183-3156, dated 23 June 2025. As the CPSP letter represented approval of the research synopsis rather than institutional ethical clearance, the name, approval number and date of the responsible institutional review board or ethics committee should be reported separately from the original hospital record. Written informed consent was obtained from the parent or legal guardian of every participant, and age-appropriate assent was obtained from children capable of understanding the study procedures. Participant confidentiality was maintained through coded study identifiers and restricted access to identifiable information.

 A total of 168 children were enrolled through non-probability consecutive sampling. Children of either sex, aged 6–16 years, with a closed diaphyseal femoral fracture confirmed on anteroposterior and lateral radiographs were eligible. Children with open fractures, pathological fractures, associated neurovascular injury or insufficiency, significant head injury, or another injury likely to interfere with postoperative rehabilitation or outcome assessment

were excluded. Children whose parents or legal guardians declined consent were not enrolled. The approved protocol specified a sample of 168 participants, with 84 participants in each group. However, the expected outcome proportions, clinically important difference, statistical power, level of significance and allowance for attrition used in the original sample-size calculation were not available in the supplied material and should be retrieved from the approved synopsis before submission.

 After eligibility assessment and consent, participants were assigned in a 1:1 ratio using a computer-generated random sequence. Eighty-four children were allocated to titanium elastic nailing and 84 to submuscular compression plating. The available study records did not identify the software used to generate the sequence, the person responsible for sequence generation, whether block or stratified randomization was used, or the mechanism employed to conceal upcoming assignments. Allocation concealment was therefore not claimed. These details should be added only after verification from the original randomization record.

 All procedures were performed by consultant orthopaedic surgeons with at least five years of operative experience. For titanium elastic nailing, the fracture was reduced under fluoroscopic guidance, and two appropriately contoured flexible titanium nails were introduced through medial and lateral metaphyseal entry points. The nails were advanced across the reduced fracture and seated proximally to provide balanced elastic stability while preserving the fracture site and periosteal circulation. For submuscular plating, indirect reduction was achieved under fluoroscopy, a lateral plate was passed through a submuscular tunnel across the fracture, and proximal and distal fixation was obtained through limited incisions while avoiding direct exposure of the fracture. Final length, alignment, rotation and implant position were assessed fluoroscopically. Implant diameter, plate length, screw configuration, surgical approach and reduction details should be added from the operative records because they were not included in the supplied dataset.

 Baseline information was recorded on a structured study proforma and included age, sex, weight, height, body mass index, mechanism of injury, affected side, anatomical fracture location and operative duration. Fracture location was classified as proximal, middle or distal diaphyseal. Although fracture pattern had been listed as a planned variable, detailed configurations such as transverse, oblique, spiral or comminuted morphology and classification as length-stable or length-unstable were not available in the reported dataset. These characteristics should therefore be added from the radiographic records or acknowledged as unavailable.

 Both groups received postoperative analgesia, wound care, mobilisation and rehabilitation according to the departmental protocol. Clinical and radiographic reviews were undertaken during the early postoperative period, including a monitoring visit at approximately six weeks and the principal outcome assessment at three months. The six-week visit was used for routine evaluation of wound healing, pain, range of motion, alignment and progression of weight-bearing and was not treated as a separate comparative endpoint. The exact timing of hip and knee exercises, partial weight-bearing and full weight-bearing was not documented in the supplied material and must be verified from the departmental protocol before final publication.

 The primary outcome was the proportion of children achieving an excellent Flynn functional outcome at three months. Flynn outcomes were classified as excellent when limb-length inequality was less than 1 cm, angular malalignment was no more than 5°, pain was absent and no complication occurred; satisfactory when limb-length inequality was less than 2 cm, malalignment was no more than 10°, pain was absent and any complication was minor and resolved; and poor when limb-length inequality exceeded 2 cm, malalignment exceeded 10°, pain persisted or a major complication or lasting morbidity occurred. The secondary outcomes were radiological union at three months, operative duration and treatment-related complications.

 Radiological union was assessed on anteroposterior and lateral radiographs. A good radiological outcome, subsequently reported as union achieved, was defined as bridging callus across at least three of four cortices on orthogonal views, with substantial reduction or disappearance of the fracture line. A poor radiological outcome, subsequently reported as union not achieved, was defined as failure to meet these criteria at the three-month assessment. Implant migration, loss of reduction, angular deformity, delayed union and other radiographic complications were also recorded. Blinding of functional and radiographic outcome assessors was not documented and was therefore not claimed.

 Data were analysed using IBM SPSS Statistics version 19.0. Baseline characteristics were summarized descriptively and were not interpreted as tests of successful randomization. Continuous variables were presented as mean and standard deviation when normally distributed and as median and interquartile range when non-normally distributed. Categorical variables were reported as frequencies and percentages. The overall three-category Flynn outcome was compared using Pearson’s chi-square test or Fisher’s exact test, as appropriate. For the primary analysis, excellent outcomes were also compared with non-excellent outcomes, and the risk ratio and absolute risk difference were reported with 95% confidence intervals. Radiological union was compared using the chi-square or Fisher’s exact test and was accompanied by a risk ratio and risk difference with 95% confidence intervals. Operative duration was compared using the independent-samples t-test, with the mean difference and 95% confidence interval reported; the Mann–Whitney U test was used if normality assumptions were not satisfied.

 Because only the three-month assessment was retained as the formal study endpoint, repeated-measures analysis was not required. All 168 randomized participants appeared in the three-month dataset and were analysed in their originally assigned groups, consistent with the intention-to-treat principle. No missing three-month outcomes were evident in the supplied tables. Any treatment crossover, protocol deviation or loss to follow-up should nevertheless be confirmed from the source records and reported in the final CONSORT flow diagram. All tests were two-sided, and statistical significance was defined as p≤0.05.

A total of 168 children with radiographically confirmed diaphyseal femoral fractures were included in the analysis. Of these, 84 were allocated to titanium elastic nailing and 84 to submuscular compression plating. The supplied dataset contained three-month outcome records for all randomized participants. Baseline characteristics were presented descriptively and were not interpreted as evidence of successful randomization.

The mean age was 11.3 ± 2.7 years in the titanium elastic nail group and 10.9 ± 2.7 years in the submuscular plate group. Mean body weight was 38.9 ± 10.2 kg and 39.08 ± 10.9 kg, respectively, while the corresponding mean heights were 143.6 ± 15.2 cm and 141.2 ± 16.4 cm. Mean body mass index was 18.7 ± 3.12 kg/m² in the titanium elastic nail group and 19.3 ± 3.02 kg/m² in the plating group.

 The titanium elastic nail group included 50 male participants (59.5%) and 34 female participants (40.5%), whereas the submuscular plate group included 56 males (66.7%) and 28 females (33.3%). Primary-level education was recorded in 19 children (22.6%) in the titanium elastic nail group and 22 (26.2%) in the plating group. Secondary education was recorded in 30 (35.7%) and 36 (42.9%) children, matriculation in 26 (31.0%) and 20 (23.8%), and intermediate education in 9 (10.7%) and 6 (7.1%), respectively.

Road-traffic accidents were the most frequent mechanism of injury, accounting for 40 cases (47.6%) in the titanium elastic nail group and 43 (51.2%) in the submuscular plate group. Falls accounted for 33 (39.3%) and 31 (36.9%) fractures, sports-related injuries for 8 (9.5%) and 7 (8.3%), and other mechanisms for 3 (3.6%) cases in each group. All fractures were closed.

 Mid-diaphyseal fractures predominated, occurring in 56 children (66.7%) treated with titanium elastic nails and 57 (67.9%) treated with submuscular plates. Proximal diaphyseal fractures occurred in 14 (16.7%) and 10 (11.9%) children, whereas distal diaphyseal fractures were recorded in 14 (16.7%) and 17 (20.2%), respectively. Right-sided fractures affected 41 children (48.8%) in the titanium elastic nail group and 45 (53.6%) in the plating group.

Operative duration was shorter with titanium elastic nailing. The mean duration was 69.29 ± 15.2 minutes for titanium elastic nailing and 107.0 ± 19.8 minutes for submuscular plating. The mean difference was 37.71 minutes longer for plating, with a 95% confidence interval of 32.33–43.09 minutes (p<0.001).

 At three months, the overall distribution of Flynn functional outcomes differed between the groups (p=0.005). Excellent outcomes were achieved by 32 children (38.1%) in the titanium elastic nail group and 53 (63.1%) in the submuscular plate group. Satisfactory outcomes occurred in 32 (38.1%) and 19 (22.6%) children, while poor outcomes occurred in 20 (23.8%) and 12 (14.3%), respectively.

 When the primary outcome was analysed as excellent versus non-excellent function, children treated with submuscular plates were 1.66 times as likely to achieve an excellent outcome as those treated with titanium elastic nails (risk ratio 1.66; 95% confidence interval 1.21–2.28; p=0.001). The absolute risk difference was 25.0 percentage points in favour of plating (95% confidence interval 10.4–39.6 percentage points).

 Radiological union at three months was achieved in 56 children (66.7%) treated with titanium elastic nails and 57 (67.9%) treated with submuscular plates. Union had not been achieved in 28 (33.3%) and 27 (32.1%) children, respectively. Submuscular plating was not associated with a significant difference in three-month union compared with titanium elastic nailing (risk ratio 1.02; 95% confidence interval 0.82–1.26; p=0.869). The absolute risk difference was 1.2 percentage points (95% confidence interval −13.0 to 15.4 percentage points).

 No comparative safety conclusion was drawn because event-specific data on infection, implant irritation, malalignment, limb-length discrepancy, implant migration, loss of reduction, neurovascular injury and reoperation were not supplied.

Table 1. Baseline demographic and anthropometric characteristics

 Table 2. Injury, fracture and operative characteristics

 Table 3. Functional and radiological outcomes at three months

The present randomized controlled trial compared early functional and radiological outcomes after titanium elastic nailing and submuscular compression plating in children with diaphyseal femoral fractures. At the three-month assessment, submuscular plating was associated with a higher proportion of excellent Flynn functional outcomes, whereas radiological union was nearly identical between the groups.

Titanium elastic nailing required substantially less operative time. These findings indicated that submuscular plating provided an early functional advantage without demonstrating superior short-term radiographic healing, although the procedure required a longer period in the operating theatre.

Excellent Flynn outcomes were recorded in 63.1% of children treated with submuscular plates and 38.1% of those treated with titanium elastic nails. Children receiving plate fixation were approximately 1.66 times more likely to achieve an excellent functional outcome, with an absolute difference of 25 percentage points between the groups. Poor functional results were also less frequent after plating. The Flynn classification includes limb-length inequality, angular malalignment, pain and treatment-related complications; therefore, the difference may have reflected better early comfort, alignment or functional restoration rather than a difference in fracture union alone. However, individual components of the Flynn score were not reported separately, and the mechanism responsible for the observed functional difference could not be determined from the available data.

 The early functional advantage was broadly consistent with previous comparative research. One study reported excellent outcomes in 89% of children treated with locking compression plates and 83.8% of those managed with titanium elastic nails, while earlier union was also observed after plate fixation (8). A randomized study conducted in Lahore similarly reported more favourable early functional outcomes with submuscular plating, although radiological healing remained comparable between the two treatments (9). Differences in follow-up duration, fracture characteristics, implant design and outcome definitions limited direct comparison, but the direction of the functional findings was generally consistent with the present results.

 Evidence from systematic reviews has also suggested that plating may be associated with a greater likelihood of excellent functional recovery. A meta-analysis involving six studies and 568 children reported more favourable functional outcomes after plate fixation, without a consistent difference in time to union (10). Another review of school-aged children found that plating was associated with longer operative duration and greater blood loss, while elastic nailing was associated with higher frequencies of implant irritation and malalignment (11). These findings provided context for the present functional results but could not substitute for complication data from the current trial.

 Radiological union at three months was achieved in 66.7% of children treated with titanium elastic nails and 67.9% of those treated with submuscular plates. The risk ratio was close to unity, and the confidence interval included the possibility of benefit or disadvantage with either procedure. Both techniques therefore produced comparable early radiological healing within the available follow-up period. Titanium elastic nails provide relative stability and controlled micromotion, which encourage callus formation, whereas submuscular plating preserves the fracture environment through indirect reduction and limited periosteal disruption. The similar union proportions suggested that both constructs maintained biological conditions compatible with healing, although longer observation would have been required to assess complete union, delayed union and remodelling (12).

 The difference between functional and radiological outcomes was clinically noteworthy. Radiographic callus formation does not necessarily correspond directly with pain-free movement, limb alignment, joint mobility or return to normal activities. Submuscular plating may have provided more rigid control of alignment during early recovery, while nail prominence or local irritation may have affected some children treated with elastic nails. Nevertheless, these explanations remained speculative because implant irritation, pain severity, angular deformity, limb-length discrepancy and range of motion were not reported as separate outcomes. Future studies should analyse these components individually to clarify why functional grades differed despite similar radiological union (13,14).

 Operative duration represented a clear advantage of titanium elastic nailing. The mean operation was approximately 38 minutes shorter than submuscular plating, and the confidence interval indicated a substantial and statistically significant difference. Previous comparative studies have similarly reported shorter operative times with elastic nails (11,12). The additional time required for plate fixation may relate to plate tunnelling, indirect reduction, fluoroscopic assessment and placement of multiple screws. Shorter surgery may reduce theatre occupancy and anaesthetic exposure, although blood loss, anaesthetic complications, resource use and cost were not recorded in the present study. The practical importance of the operative-time difference therefore requires evaluation alongside clinical outcomes and institutional resources (15,16).

 Previous literature has not uniformly favoured plating. A comparative study involving predominantly mid-shaft fractures reported similar clinical outcomes between techniques and identified advantages of elastic nailing in operative time, blood loss and cost (12). Variation between studies may be related to age, body weight, fracture pattern, anatomical level and surgeon preference. Earlier publications have suggested that these factors influence implant selection, but the present study did not report detailed fracture configuration, stability classification or weight-based subgroup outcomes. Consequently, the current findings did not establish that plating was superior in heavier children or unstable fractures, nor did they confirm that elastic nails were preferable for particular fracture patterns. Such recommendations should be based on adequately powered, prespecified subgroup analyses rather than extrapolation from the overall comparison (17,18).

 The study had several strengths. It included 168 children equally allocated between treatment groups, which was larger than many previous single-centre comparisons. Functional and radiological outcomes were assessed using predefined criteria, and effect estimates with confidence intervals allowed the magnitude and precision of the treatment differences to be considered. The restriction of the analysis to the three-month endpoint also ensured consistency with the study period from 25 June to 10 December 2025 (19,20).

 Several limitations remained. The study was conducted at one tertiary care hospital, limiting generalizability. The short follow-up period prevented assessment of complete remodelling, persistent deformity, limb-length discrepancy, implant removal, refracture and long-term activity. Allocation concealment and assessor blinding were not documented. Detailed fracture morphology, rehabilitation adherence, blood loss, hospital stay, cost and patient-reported outcomes were unavailable. In addition, complications and adverse events were not systematically presented. The study therefore could not determine whether the procedures had comparable safety, and it was unlikely to have sufficient statistical power to detect uncommon complications such as deep infection, implant failure or neurovascular injury.

 Future multicentre trials should incorporate longer follow-up, concealed allocation, blinded outcome assessment and standardized rehabilitation. Fractures should be classified by stability, configuration and anatomical location, with prespecified analyses according to age and body weight. Complications, cost-effectiveness, implant-removal morbidity, school absence and caregiver burden should also be evaluated. Within the available three-month follow-up, submuscular compression plating produced better early functional outcomes, while radiological union remained comparable and titanium elastic nailing offered a shorter operative duration.

Submuscular compression plating resulted in better early functional recovery than titanium elastic nailing, while both techniques achieved comparable radiological union at three months. Titanium elastic nailing required a shorter operative time. Within the five-and-a-half-month study period, these findings indicated that submuscular plating offered an early functional advantage, whereas both fixation methods remained effective options for the management of paediatric diaphyseal femoral fractures.

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