1Assistant Professor, Department of Orthopaediatrics Krishna Institute of Medical Sciences,
Krishna Viswa Vidyapeeth “Deemed to be University”, Karad –415110, Maharashtra.
3,4Director, Akildev IPR and Research Services, Greater Noida, UP, India.
5Bharati Vidyapeeth College of Pharmacy, Palus, Maharashtra, India.
*Corresponding Author E-mail: shivajiavatekims@outlook.com
ABSTRACT:
Intertrochanteric femoral fractures are of great interest all around the world. They are the most often performed fracture type, and the high expense of treatment required following injury has made them a critical health resource concern. A higher predisposition towards Intertrochanteric fracture is observed in females than males due to osteoporosis A substantial demand is placed on the implanted hardware, as the subtrochanteric region of the femur experiences mechanical forces several multiples of the patient’s weight.The primary objective of this study was to evaluate the functional result of inter- and sub-trochanteric femur fractures treated with Proximal Femur Nail Antirotation-II. To improve the rotational stability of the proximal fracture fragment, the trochanteric fixation nail (TFN) was designed. To lessen bone tension at the isthmus, the diameter of the distal tip of the nail was lowered. The research was carried out in the Department of Orthopaedics, Krishna Institute of Medical Sciences, Karad. The research was carried out between June 2019 and June 2021. The Department of Ethics of Krishna Institute of Medical Sciences, Deemed to be University Karad, granted the ethics committee permission. There were 60 individuals in the research who had intertrochanteric and subtrochanteric femur fractures. After receiving informed written consent in the specified way, all participants were included. In summary, PFN A-II is a stable, biomechanically acceptable implant with a clear advantage over other implants for treating stable and unstable intertrochanteric fractures, particularly those in the elderly, and linked with osteoporotic bone. The benefits of the PFN A-II are noticeable with the right surgical approach, with a bare minimum complication rate.
KEYWORDS: Biomechanical, Bone, Fracture, Intertrochanteric, Trochanteric Fixation Nail.
INTRODUCTION:
Worldwide, there is a great deal of curiosity about intertrochanteric femur fractures. Due to the high expense of post-injury treatment, they are the most commonly operated fracture variety and have emerged as a significant health resource problem. High-energy trauma in juvenile patients can produce fracture patterns comparable to those seen in low-energy, elderly patients. Because of osteoporosis, women have a greater risk of intertrochanteric fracture than men do 1.
About 90% of hip fractures in patients over 50 are caused by low-energy falls from standing height, with females more likely to suffer a hip fracture than males. High-energy hip fracture is a comparatively uncommon condition that affects menyounger than 40 more frequently than women 2.
The treating physician faces a challenge with femur intertrochanteric and subtrochanteric fractures because the deforming pressures on both the proximal and distal segments are challenging to control, particularly given the proximal segment's naturally short length. Due to the draw of the iliopsoas, gluteus medius, and short external rotators, respectively, the distinctive deformity observed is a bent, abducted, and externally rotated proximal section. The unopposed draw of the adductor magnus and longus frequently shortens and adducts the distal section.The physician must make sure that the reduction is kept all through the healing process despite the challenges encountered in achieving an anatomic reduction. The subtrochanteric area of the femur encounters mechanical pressures that are many times the patient's weight, placing a significant strain on the inserted hardware. To achieve this, a variety of anchoring techniques, including intramedullary (IM) and extramedullary devices, are available. For our therapy modalities to advance, therapeutic concepts for pertrochanteric fractures must change. To better repair the structure of the hip, Whitman recommended reduction and stabilization with traction, abduction, and internal rotation in 1902 3.
The development of Smith Peterson's triflange nail for hip fractures signaled the end of conservative therapy. It was believed that this was a step in the right direction for stabilizing the broken leg and lowering mortality. To quickly mobilize the patient, the triflange construction offered mechanical support while controlling rotational instability. The most frequently used design consisted of a side plate with adjustable lengths and neck angles and a blunt-tipped cannulated screw build. A keyed hole for improving rotary stability was present 4. Devices with varying lengths, femoral geometry, and proximal screw holes were introduced during the cephalomedullary implant period using a closed method under fluoroscopic supervision to allow fixation with screws into the femoral head. The oldest forms were impaction-type nails like the Y-nail developed by Küntscher 5 along with the zickel nail. These nails had no distal locking and were not reamed. The Grosse-Kempf gamma nail and the Russell- Taylor reconstruction nail, two novel intramedullary devices, helped interlocking methods acquire favor between the 1980s and 1990s.These devices fixed the femoral head and neck by inserting a compression bolt into an intramedullary device. The proximal fracture fragment's rotary stability was improved with the development of the trochanteric fixation needle (TFN). To lessen the bone tension at the isthmus, the nail's distal tip's thickness was decreased. This reduced the possibility of iatrogenic femur shaft injuries during surgery. It also had the advantage of enabling the fracture hematoma to remain unaffected during and after fracture stabilization 6. This study's goal is to evaluate the practical results of proximal femur nail antirotation-II treatment for inter- and sub-trochanteric fractures of the femur.
(a) Study Objectives:
The study aims to assess the functional outcomes of using the Proximal Femur Nail Anti-rotation-II for treating inter- and sub-trochanteric femur fractures, as well as to examine the surgical entry point, measure the duration of the surgical procedure, evaluate the stability of the implant in osteoporotic bone through regular post-surgery follow-ups, and determine the duration of the patient's mobility during the postoperative period.The study had 60 patients with intertrochanteric and subtrochanteric femur fractures. All the participants were included after taking informed written consent in the prescribed format. This was a prospective analytical study done to assess the functional outcome of intertrochanteric and subtrochanteric fracture femur operated with Proximal femur nail anti-rotation – II (PFNA II).
(b) Sample and Instruments:
The Orthopaedics Department at the Krishna Institute of Medical Sciences in Karad was where this research was carried out. The research was carried out between June 2019 and June 2021. The Department of Ethics at Krishna Institute of Medical Sciences Deemed to be University Karad, approved the request from the ethics council. 60 individuals with subtrochanteric and intertrochanteric femur fractures participated in the research. Following the receipt of signed informed permission in the required manner from each participant, inclusion was made. Proximal femur nail antirotation-II was used in this prospective analytical research to evaluate the functional result of femurs with intertrochanteric and subtrochanteric fractures. (PFNA II).
(c) Data Collection:
According to Singh's index, all patients were split into two groups: Group I, which contained patients with Grade IV, V, and VI osteoporosis, and Group II, which contained patients with Grade I, II, and III osteoporosis. Following is a summary of the study's data:
(d) Inclusion Criteria:
All patients were above 18 years of age. Patients were able to walk with or without aid prior to their injury. They were having stable/unstable intertrochanteric and subtrochanteric femur fracture.
(e) Ethics Approval:
The ethics committee clearance was given by Department of Ethics under Krishna Institute of Medical Sciences Deemed to be University Karad. The patients who met the inclusion and exclusion criteria were included in the study after taking informed valid consent.
(f) Preoperative Preparation:
Pre anaesthetic check-up was carried out. Patient's consent was taken for the surgery. Prior to surgery, patient was kept Nil by Mouth for a period of 6 hours. However, antibiotic was given intravenously30 minutes prior to surgery. Subsequently, operative site was marked. Random chit method was adopted to decide the bony entry point. We had two points of bony entry, namely; tip of greater trochanter and medial to tip of greater trochanter.
In this research work, there was a 100% union rate. The clinical union was determined by the lack of pain and tenderness and the patient's ability to actively elevate the afflicted limb, while the radiological union was determined by the bridging of the trabecular pattern as measured by the RUSH score.After six weeks, three months, and six months, the average Harris Hip Score was 72.89, 79.28, and 85.78, respectively. After six months, 31 A1 fracture patterns had the highest percentage of favorable outcomes. In the research by Leventkarapinar et al., comparable outcomes were observed. (mean Harris Hip score 80.75 at end of 6 months).Figures below indicate the procedure and outcomes of the study. Figure 1 represents AP and Lateral C-ARM views depicting the entry point medial to the tip of greater trochanter. The Sex distribution of the population was male 31 and female 29.Patients in the current research varied in age from 45 to 85 years old. The spread is charted belowshown in Figure 2.
Figure 1: AP and Lateral C-ARM views depicting the entry point medial to the tip of greater trochanter
Figure 2: Represents the Age Distribution spread of the population.
The side distribution spread of the population was 33 patients with left-side involvement and 27 instances with right-side involvement.Patients were divided into Groups 1 and 2 according to the degree of osteoporosis existing at the time the protracted fracture first appeared, based on the severity of the condition as measured by Singh's Index.
Table 1: Shows the distribution of the fracture pattern
|
Fracture Pattern |
N |
Percentage |
|
S31A1 |
38 |
63.33 |
|
31A2 |
16 |
26.67 |
|
31A3 |
6 |
10 |
Pre-operative X-rays of the pelvis with both hips in anteroposterior view (in traction and 15 degrees internal rotation) and lateral view of the afflicted hip were used to classify the fractures according to the AO categorization scheme. The skin-to-skin closing time served as the study's definition of working time. In the current research, the operating duration varied from 40 to 95 minutes. The total time taken was 74.75 ±12.43 minutes, Table 2.
Table 2: Operating time
|
Operating Time (min) |
N |
Percentage |
|
<50 |
4 |
7% |
|
51-60 |
3 |
5% |
|
61-70 |
15 |
25% |
|
71-80 |
23 |
38% |
|
81-90 |
12 |
20% |
|
>90 |
3 |
5% |
At 6 weeks, 79.28 ±3.87, and 6 months, the average Harris Hip score was 72.88 ±2.05, 79.28 ±3.87, and 85.78 ±5.39. A statistically significant upward tendency in the Harris Hip Score is seen using the ANOVA test, with an F Statistic value of 364.72 and p-value <0.001 shown in Table 3.
Table 3: HHS's rising tendency at different time intervals
|
Harris Hip Score |
Mean |
SD |
F- Statistic Value |
P Value |
|
At 6 Weeks |
72.88 |
2.05 |
364.72 |
<0.001 |
|
At 3 Months |
79.28 |
3.87 |
||
|
At 6 Months |
85.78 |
5.39 |
The Harris Hip Score was used to evaluate the functional result of Proximal Femur Nail Antirotation-II-treated Intertrochanteric and Subtrochanteric Femur Fractures at 6 weeks, 3 months, and 6 months following surgery.
Table 4: Distribution of radiologically required duration for unity (in weeks)
|
Radiological Time to Union (Weeks) |
N |
Percentage |
|
10 |
18 |
30% |
|
14 |
22 |
36.66% |
|
18 |
15 |
25% |
|
22 |
5 |
8.34% |
The AO categorization method was used to group 60 individuals with intertrochanteric and subtrochanteric femur fractures in our research. Our research included 60 patients, of which 28 belonged to Group 1—those with Singh's Osteoporotic Index grades IV, V, and VI—and 32 to Group 2—those with Singh index gradeI, II, and III. In patients with osteoporosis, 2 out of 32 (or 6.25%) instances of implant failure and helical screw back out were observed. (Grade I, II and III). On the third post-operative day, 73.33% of the research participants were activated by beginning toe-touch weight bearing. Due to extensive bone commination, delayed weight bearing was started for 26.6% of the patients at 6 weeks after surgery. The duration of the union, as seen on radiography, ranged from 10 to 22 weeks, with an average of 14.6 weeks. In 87% of patients, excellent to satisfactory outcomes were attained. Excellent to Good outcomes were observed in 78% of the intertrochanteric fracture femurs repaired in research by G.N. Kiran Kumar et al. 16 using the conventional trochanteric fixation nail (TFN) 17.
The broader proximal width of the nail than the conventional TFN is attributable to a stiffer build. The nail's flexible point and laterally compressed cross-section make insertion simpler. The greater trochanter can be easily inserted due to the 5-degree medial-lateral inclination. The tight grip of the PFNA-II helical blade in the cancellous bone offers extra anchoring, which is particularly important in osteoporotic bone5-7. Patients with a narrow femoral neck diameter, which is a frequent discovery in the Asian community, greatly benefit from the presence of a single blade for proximal locking. Such patients' necks cannot fit two securing screws, as is the situation with the conventional trochanteric fixation nail 18. The AO categorization method was used to group 60 individuals with intertrochanteric and subtrochanteric femur fractures in our research19. The orthopedic community has acknowledged that intertrochanteric fracture of the tibia poses a significant problem. The primary job that must be completed in the shortest amount of time is to achieve fracture union and the return of optimum function with the fewest complications.
A fracture of the intertrochanteric femur results from the comminution of the posteromedial cortical of the proximal femur. Weight-bearing increases the bending force over extramedullary implants, such as the dynamic hip screw, resulting in problems like implant fracture, screw cut-out, or plate from shaft detachment12. This prompted the development of intramedullary devices like the PFNA-II, which, in theory, offered a more efficient method of load transmission due to its location. Compared to the Dynamic Hip Screw, it has a shortened moment arm, lowering the possibility of device failure (especially incidences of lag screw cut-out) 20. Traction, adduction, and internal rotation of the afflicted lower leg were used to reduce the fracture location. After the fracture had been temporarily diminished, an image intensifier was used to acquire fluoroscopy images in the sagittal and coronal planes. (C-Arm)7. Traction was increased or decreased, and abduction, adduction, internal rotation, and other changes were made as needed. To prevent the most typical misalignments—varus deformity, rear sag, and excessive internal rotation—fluoroscopic pictures were closely examined. In individuals for whom closed reduction was unsuccessful, open reduction was performed.
Cortical rupture of the greater trochanter or the medial wall of the proximal tibia may result from forceful implantation. Early mobilization allowed for the avoidance of recumbence-related complications and the quickest possible return of the patients to their pre-frail state. After six weeks, three months, and six months, the average Harris Hip Score was 72.89, 79.28, and 85.78, respectively. PFN A-II is a stable, biomechanically appropriate implant with a unique design that has clear benefits over other implants for treating stable and unstable intertrochanteric fractures, particularly those in elderly patients and those linked to osteoporotic bone. The benefits of the PFN A-II are noticeable with a very low complication rate when surgery is performed with the proper medical procedure.
1. Mahomed NN et al. Rates and outcomes of primary and revision total hip replacement in the United States Medicare population. The Journal of Bone and Joint Surgery. 2003; 85(1): 27–32. doi: 10.2106/00004623-200301000-00005.
2. Hwang LC et al. Intertrochanteric fractures in adults younger than 40 years of age. Archives of Orthopaedic and Trauma Surgery. 2001; 121(3): 123–126. doi: 10.1007/s004020000190.
3. WhitmanR.VII A new method of treatment for fracture of the neck of the femur, together with remarks on Coxa Vara. Annals of Surgery.1902; 36(5): 746–761. doi: 10.1097/00000658-190211000-00007.
4. The classic: treatment of fractures of the neck of the femur by internal fixation. Clinical Orthopaedics and Related Research.1967; 54:3–11.
5. Li W, et al. Comparison of titanium elastic intramedullary nailing versus injection of bone marrow in treatment of simple bone cysts in children: a retrospective study. BMC Musculoskeletal Disorder. 2016; 17(1): 343. doi: 10.1186/s12891-016-1184-7.
6. SaudanM. Pertrochanteric fractures: is there an advantage to an intramedullary nail?Journal of Orthopaedic Trauma. 2002; 16(6): 386–393. doi: 10.1097/00005131-200207000-00004.
7. Kasha, S. et al. PFNA-II in peritrochanteric femur fractures: experiences in osteoporotic elderly Indians. International Journal of Research and Review. 2017; 4(2): 56-62.
8. Frandsen PA and Andersen PE. Treatment of displaced fractures of the femoral neck: Smith-Petersen osteosynthesis versus sliding-nail-plate osteosynthesis. Acta Orthopaedica Scandinavica. 1981; 52(5): 547–552. doi: 10.3109/17453678108992145.
9. SinghM, Femoral trabecular-pattern index for evaluation of spinal osteoporosis, Annals of Internal Medicine. 1972; 77(1):63. doi: 10.7326/0003-4819-77-1-63.
10. Weissman SL and Salama R. Trochanteric fractures of the femur. Treatment with a strong nail and early weight-bearing.Clinical Orthopaedics and Related Research. 1969; 67:143–50.
11. Lotz JC, Cheal EJ and Hayes WC. Fracture prediction for the proximal femur using finite element models: Part I - Linear Analysis. Journal of Biomechanical Engineering. 1991; 113(4): 353–360. doi: 10.1115/1.2895412.
12. Taylor KE et al. Stress and strain distribution within the intact femur: compression or bending? Medical Engineering and Physics. 1996; 18(2): 122–131. doi: 10.1016/1350-4533(95)00031-3.
13. Medoff RJ and Maes K. A new device for the fixation of unstable pertrochanteric fractures of the hip. The Journal of bone and joint surgery- Ser. A, 1991; 73(8):1192-99. doi: 10.2106/00004623-199173080-00008.
14. Detenbeck LC. Symptomatic Paget disease of the hip. Journal of American Medical Association. 1973; 224(2): 213. doi: 10.1001/jama.1973.03220150025007.
15. Jewett BA and Collis DK. Radiographic failure patterns of polished cemented stems. Clinical Orthopaedics and Related Research. 2006; 453: 132–136. doi: 10.1097/01.blo.0000246540.64821.73.
16. Kumar GNK et al.Treatment of unstable intertrochanteric fractureswith proximal femoral nail antirotation II: Our experience in Indian patients. Open Orthopaedics Journal. 2015; 9(1): 456–459. doi: 10.2174/1874325001509010456.
17. KarapinarLet al. Proximal femoral nail anti-rotation (PFNA) to treat peritrochanteric fractures in elderly patients. European Journal of Orthopaedic Surgery and Traumatology. 2012; 22(3): 237–243. doi: 10.1007/s00590-011-0810-1.
18. Loo W, Loh S and Lee H. Review of proximal nail antirotation (PFNA) and PFNA-2 – our local experience, Malaysian Orthopaedic Journal. 2011; 5(2); 1–5. doi: 10.5704/MOJ.1107.001.
19. Boyd HB. Classification and treatment of trochanteric fractures. Archives of Surgery. 1949; 58(6): 853. doi: 10.1001/archsurg.1949.01240030864012.
20. Wei M et al. Impact of bone fracture on ischemic stroke recovery, Int. J. Mol. Sci. 2018; 19(5): 1533. doi: 10.3390/ijms19051533.
21. Goyal, M., et al. Endovascular treatment for cerebral venousthrombosis: current status, challenges, and opportunities. Journalof Neuro Interventional Surgery. 2022; 14(8):788-7.
Received on 20.09.2023 Modified on 27.10.2023
Accepted on 19.11.2023 © RJPT All right reserved
Research J. Pharm. and Tech 2023; 16(12):5884-5888.
DOI: 10.52711/0974-360X.2023.00953