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Long-term functional outcomes of BIFOLD osteosynthesis in distal femoral fractures with metaphyseal comminution: A retrospective analysis
⁎Corresponding author: Clevio Desouza. ceviod@gmail.com
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Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
This retrospective study aimed to evaluate the long-term functional outcomes of BIFOLD osteosynthesis, employing retrograde nailing and distal femoral locked plating, in patients with distal femoral fractures and metaphyseal comminution.
A retrospective analysis was conducted on patients treated for distal femur fractures with metaphyseal comminution between 2012 and 2022, with a minimum follow-up of 2 years. Inclusion criteria encompassed distal femur fractures with metaphyseal comminution, excluding specific conditions. BIFOLD osteosynthesis was employed in all 33 cases, utilizing retrograde SIGN (Surgical Implant Generation Network Nail) and distal femoral locking plates. Primary outcome measures included radiographic and functional outcomes assessed through the Sanders functional evaluation score, with secondary outcomes focusing on perioperative or postoperative complications.
A total of 33 patients (21 male, 12 female) were included, with an average age of 51.4 years. BIFOLD osteosynthesis exhibited an average radiographic fracture healing time of 6.2 ± 2.5 months. The procedure's average operative time was 100 ± 15 min, and blood loss averaged 420 ± 50 ml. According to Sanders criteria, 28 patients (84.84 %) demonstrated well-to-excellent functional outcomes, while 3 patients (9.09 %) reported fair outcomes, and 2 patients (6.06 %) reported poor outcomes. No significant shortening or implant failure occurred, and all patients achieved over 90 degrees of knee range of motion within 8 weeks. One patient experienced superficial infection, and two patients exhibited insignificant coronal plane deformity.
BIFOLD osteosynthesis, combining intra and extra medullary fixation principles, offers a stable construct for distal femoral fractures with metaphyseal comminution. This approach facilitates faster ambulation, pain relief, early knee joint mobilization, and significant early union, resulting in improved functional outcomes. Additionally, BIFOLD osteosynthesis helps prevent collapse, translational and rotational deformities, as well as shortening.
Keywords
Distal femur fractures
BIFOLD fixation
BIFOLD osteosynthesis
Retrograde SIGN nailing
AO/OTA classification
Metaphyseal comminution
1 Introduction
Distal femoral fractures, often resulting from high-energy trauma or minor incidents in the elderly, present a complex challenge in orthopedic practice. The intricate nature of these fractures, especially when accompanied by metaphyseal comminution, demands a nuanced approach to ensure optimal outcomes. Despite advancements in surgical techniques and implant technologies, achieving satisfactory results in the management of these fractures remains elusive, often leading to complications such as collapse, implant failure, and prolonged disability.1,2
The classification of distal femoral fractures, as outlined by the AO/OTA system, underscores the varied patterns and complexities encountered in clinical practice. Fractures of this nature necessitate careful consideration of factors like bone quality, alignment, and articular surface restoration.3,4 The goals of treatment extend beyond fracture union to encompass functional recovery, preservation of limb anatomy, and early mobilization.5
Traditional fixation methods, including plates, intramedullary nails, and external fixations, have been employed to address distal femoral fractures. However, fractures with metaphyseal comminution pose unique challenges, often resulting in suboptimal outcomes and long-term disabilities.6–8 The limitations of existing techniques have spurred the development of innovative approaches aimed at enhancing stability, promoting faster ambulation, and preventing common complications associated with these fractures.9–11
In this context, the BIFOLD osteosynthesis technique emerges as a promising paradigm. By combining the principles of retrograde nailing and distal femoral locked plating, BIFOLD aims to provide a more stable construct, particularly in cases involving metaphyseal comminution. The focus on achieving early knee joint mobilization, preventing collapse, and ensuring rapid union sets this technique apart, offering a potential solution to the persistent challenges posed by distal femoral fractures.12–14
This retrospective analysis delves into the long-term functional outcomes of BIFOLD osteosynthesis, shedding light on its efficacy in addressing the complexities of distal femoral fractures with metaphyseal comminution. Through a comprehensive evaluation of radiographic and functional parameters, we aim to contribute valuable insights into the evolving landscape of orthopedic interventions for this challenging subset of fractures.
2 Material and methods
This retrospective study sought to investigate the radiological and functional outcomes of BIFOLD osteosynthesis in distal femoral fractures with metaphyseal comminution. The study spanned the period from 2012 to 2022, and ethical approval was obtained from the institutional review board.
2.1 Patient selection
The study included patients who underwent surgical intervention for distal femur fractures with metaphyseal comminution during the specified timeframe. Inclusion criteria comprised patients with primary distal femoral fractures, excluding those with pathological fractures, open fractures, fractures in the same extremity, previously operated fractures, non-union, malunion, and follow-up periods of less than 2 years. A total of 33 patients initially met the inclusion criteria.
2.2 Surgical technique
BIFOLD osteosynthesis was the standardized surgical approach for all included cases.
Patient Positioning: Patients are placed in a supine position on the operating table. A radiolucent bolster is positioned under the knee, allowing for a controlled degree of knee flexion (40–60°). This positioning facilitates optimal exposure and alignment during the procedure.
Tourniquet Application: An Esmarch tourniquet is applied to the proximal thigh.
Choice of Fixation: The choice between intra-articular and extra-articular fixation depends on the type of distal femoral fracture encountered. The decision was influenced by the specific fracture pattern, displacement, and other factors assessed during preoperative planning [Fig. 1].
Extra-Articular Fixation (Open Reduction): An open reduction was performed through a para-patellar approach. The goal was to achieve proper alignment and stabilization of the fracture fragments.
Primary Reduction: The initial step involved achieving a primary reduction, addressing the articular surface, and aligning the fracture fragments in the coronal, sagittal, and axial planes. Fracture fragments were temporarily held in place using reduction clamps, and provisional stabilization was achieved with the use of Kirschner wires (K-wires).
Intraoperative Imaging: Intraoperative fluoroscopy was used to assess the reduction and alignment of the distal femoral fracture. Following satisfactory reduction, an entry point was made into the femoral medullary canal using a bone awl, through the femoral intercondylar notch.
The medullary canal was gradually reamed to prepare for the insertion of the retrograde SIGN nail. The retrograde nail was inserted into the medullary canal, reaching just beyond the lesser trochanter. The nail diameter and length were chosen to achieve optimal stability and alignment.
Additional Stability with Distal Femoral Locking Plate: A Distal Femoral Locking Plate was used to provide additional stability against rotational and bending stress. The plate was positioned to offer support to the metaphyseal region, addressing the comminution and preventing collapse [ Fig. 2].
Screw Fixation: Screws were inserted through the plate into the bone to achieve secure fixation.
2.3 Postoperative management
In the immediate postoperative phase, patients were immobilized with a long-leg knee brace to prevent extension loss. Early initiation of physiotherapy, commencing on postoperative day 1, included isometric exercises for quadriceps and hamstrings, along with continuous passive mobilization of the knee joint. Gradual increments in range of motion were guided by patient tolerance, with a target of achieving 90° by 4 weeks postoperatively.
Weight-bearing was delayed for 2–4 weeks postoperatively, followed by a transition to partial weight-bearing and eventual full weight-bearing after radiological confirmation of union at 10–12 weeks. Regular outpatient follow-ups were scheduled, allowing for ongoing assessment of patient progress.
2.4 Outcome measures
The primary outcome measures were radiographic and functional evaluations. Radiographic parameters included fracture healing time, assessed through postoperative X-rays, and the absence of significant shortening or implant failure. Functional outcomes were evaluated using the Sanders functional evaluation score, encompassing range of motion, pain, deformity, walking ability, and return to work.
2.5 Statistical analysis
Descriptive statistics, including means and standard deviations, were employed to summarize demographic and clinical characteristics. The Sanders functional evaluation score was used for functional outcome categorization into excellent, good, fair, or poor outcomes. The study did not conduct a comparative biomechanical analysis but aimed to elucidate the clinical efficacy of the BIFOLD technique.
3 Results
A total of 33 patients, comprising 21 males and 12 females, with an average age of 51.4 years (range: 36–78 years), were included in the study. Table 1 shows the various pre-operative characteristics and demographic data.
| Variables | Populations studied | |
| Age | Mean | 51.4 yrs. |
| Range | 36–78 yrs. | |
| Gender | Male | 21 (63.6 %) |
| Female | 12(36.4 %) | |
| Comorbid condition | Yes | 9(27.2 %) |
| No | 24(72.8 %) | |
| Mode of Injury | Fall | 7(21.2 %) |
| RTA | 26(78.8 %) | |
| Smoking | Yes | 4(12.1 %) |
| No | 29(87.9 %) | |
| Tobacco chewing | Yes | 5(15.1 %) |
| No | 28(84.9 %) | |
Patients having supracondylar and intercondylar fractures were classified according to the AO/OATS classification.16,17 AO type A2, A3, C2 and C3 were taken into consideration excluding type A1, type B and C1 fractures. Out of the 33 cases treated with BFO fixation modality, AO/OTA Type A fracture was seen in 20 cases and type C fracture was present in 13 patients [Table 2].
| Type of fracture | Number of Cases |
| Type A2 | 5 |
| Type A3 | 15 |
| Type C2 | 10 |
| Type C3 | 3 |
All patients were followed for a minimum of two years. The average radiographic fracture healing time in the BIFOLD osteosynthesis (BFO) group was 6.2 ± 2.5 months, confirmed through postoperative X-rays.
Operative parameters indicated an average surgical time of 100 ± 15 min, with a blood loss of 420 ± 50 ml. According to the Sanders functional evaluation score, a comprehensive assessment of functional outcomes, 28 out of 33 patients (84.84 %) achieved well-to-excellent results. Three patients (9.09 %) reported fair outcomes, and two patients (6.06 %) demonstrated poor outcomes [Table 3].
| Functional Outcome | Number of Patients | Percentage |
| Well-to-excellent | 28 | 84.84 % |
| Fair | 3 | 9.09 % |
| Poor | 2 | 6.06 % |
Specifically, all patients in the BFO group attained more than 90 degrees of knee range of motion within eight weeks postoperatively [Fig. 3], highlighting the effectiveness of the intervention in promoting early joint mobilization. There were no instances of significant shortening or implant failure observed during the follow-up period.
Patients who underwent BIFOLD osteosynthesis were able to initiate weight-bearing at an average of six weeks postoperatively. Only one patient experienced a superficial infection, which resolved with antibiotic treatment based on sensitivity testing within seven days. Additionally, two patients exhibited insignificant coronal plane deformity, indicating a low incidence of postoperative complications.
4 Discussion
In the realm of distal femoral fracture management, the fixation approach significantly impacts outcomes15. Angle-stable locking plates are conventionally favored, acknowledging their reliance on bone quality for stability. However, the disadvantages, including the need for extensive soft tissue dissection and associated non-union risks, prompt exploration of alternatives.16–18
Retrograde nailing emerges as a promising strategy due to its capacity to minimize soft tissue damage and preserve bone biology, facilitating improved fracture union. Interlocking nailing systems effectively address axial compression and torsional forces, offering added stability crucial for optimal outcomes.19,20 Distal femoral locking plates are particularly beneficial for periarticular, comminuted, and osteoporotic fractures. In cases of significant comminution, dual plating may be considered to mitigate varus collapse risks, though the drawbacks of increased soft tissue dissection caution against routine adoption.21,22
Biomechanical studies, including Basci et al.23 investigation, emphasize the importance of mechanical strength and early mobilization capabilities. The combination of distal femoral anatomical locking plates and intramedullary nails is posited as an advantageous treatment for complex distal femoral fractures resulting from high-energy trauma in young adults.
Comparative biomechanical analyses underscore the superiority of intramedullary nails, exhibiting greater axial stability and reduced micro motion compared to dynamic condylar screws and locking condylar plates.24,25 Long-term assessments revealing lower malunion rates and reduced bone grafting requirements further support the preference for intramedullary nails in certain scenarios.
Wright DJ et al.26 biomechanical study comparing dual-plate (DP) and plate-nail (PN) constructs provides valuable insights. While DP constructs demonstrate superior fixation, their increased stiffness comes at the cost of extensive dissection, a crucial consideration in the clinical translation of findings.
In our patient cohort, a synthesis of fracture fixation principles was employed. Retrograde nailing offered compressive axial and rotational stability, mitigating hyperextension risks commonly associated with alternative techniques. The incorporation of a solid tibial nail, strategically oriented to prevent distal fragment hyperextension, and the use of a Distal Femoral Lateral plate provided angular stability in osteoporotic bone, mitigating coronal plane collapse risks. Early rehabilitation compliance was notably higher, contributing to better functional outcomes.
Acknowledging study limitations, including a small sample size and the absence of a biomechanical comparison, emphasizes the need for ongoing prospective research. Future laboratory investigations are warranted to comprehensively compare the biomechanical properties of the plate + solid nail combination versus plate or nail alone, providing a more nuanced understanding of their respective merits.
In conclusion, this discussion underscores the nuanced considerations in distal femoral fracture fixation strategies. While acknowledging the biomechanical advantages of certain approaches, clinical translation requires a balanced assessment of functional outcomes, patient compliance, and complication profiles. The ongoing evolution in distal femoral fracture management mandates a continued exploration of novel techniques and a commitment to larger, well-designed studies to inform evidence-based practice.
5 Conclusion
BIFOLD osteosynthesis, combining intra and extra medullary fixation principles, offers a stable construct for distal femoral fractures with metaphyseal comminution. This approach facilitates faster ambulation, pain relief, early knee joint mobilization, and significant early union, resulting in improved functional outcomes. Additionally, BIFOLD osteosynthesis helps prevent collapse, translational and rotational deformities, as well as shortening.
CRediT authorship contribution statement
Clevio Desouza: Conceptualization, Methodology, Software, Data curation, Writing – original draft, Visualization, Investigation. Nicholas Antao: Conceptualization, Methodology, Software, Data curation, Writing – original draft, Visualization, Investigation. Sanjay Londhe: Conceptualization, Methodology, Software, Data curation, Writing – original draft, Visualization, Investigation. Paras Banka: Conceptualization, Methodology, Software, Data curation, Writing – original draft, Visualization, Investigation.
Informed consent
Not Applicable.
Ethical approval
Not Applicable.
Competing interests
The authors declare no financial conflicts of interest to disclose.
Availability of data and materials
This published article contains all the data generated or analyzed during this study.
Ethical statement
Hereby, We consciously assure that for the manuscript the following is fulfilled.1)This material is the authors' own original work, which has not been previously published elsewhere.2)The paper is not currently being considered for publication elsewhere.
Consent
Patient Consent was taken.
Funding
No funding was received for the study.
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