|Year : 2021 | Volume
| Issue : 3 | Page : 80-85
Evaluation of outcome of halifax nail and proximal femoral nail antirotation-asia in management of proximal femoral fractures – A prospective comparative study
Pinaki Das, Arnab Karmakar
Department of Orthopaedics, Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karni Memorial Hospital, Kolkata, West Bengal, India
|Date of Submission||21-Jul-2021|
|Date of Decision||25-Jul-2021|
|Date of Acceptance||31-Jul-2021|
|Date of Web Publication||20-Dec-2021|
Dr. Pinaki Das
B 1512, Sector 6, CDA, Cuttack - 753 014, Odisha
Source of Support: None, Conflict of Interest: None
Objective: The objective of the study is to evaluate and compare the results of Halifax and proximal femoral nail antirotation-Asia (PFNA II) in proximal femur fractures. Methods: From December 2018 to August 2020, 30 proximal femur fracture nailing were performed. After applying the exclusion criteria, there were 24 patients to be evaluated. The patients were divided into two groups: Halifax group and PFNA II group. The scoring system used for clinical evaluation was Harris hip Score. Results: The follow-up period in both the groups was at least 6 months. The proportion of patients with improvements of Harris hip score at different time intervals of the patients treated with Halifax nail was marginally higher than that of the patients treated with Halifax and PFNA II nail but it was not significant (P > 0.05). Conclusion: No statistically significant difference was found between Halifax nail and Halifax and PFNA II nail in surgeries done at this particular institution after comparative analysis of Harris hip scores and other parameters.
Keywords: Halifax nail, Harris hip score, proximal femoral nail antirotation-Asia II nail, proximal femur fractures
|How to cite this article:|
Das P, Karmakar A. Evaluation of outcome of halifax nail and proximal femoral nail antirotation-asia in management of proximal femoral fractures – A prospective comparative study. J Orthop Dis Traumatol 2021;4:80-5
|How to cite this URL:|
Das P, Karmakar A. Evaluation of outcome of halifax nail and proximal femoral nail antirotation-asia in management of proximal femoral fractures – A prospective comparative study. J Orthop Dis Traumatol [serial online] 2021 [cited 2022 Jan 24];4:80-5. Available from: https://www.jodt.org/text.asp?2021/4/3/80/332940
| Introduction|| |
Proximal femoral fractures are found in huge numbers in the elderly population due to the prevalence of osteoporosis, loss of muscle mass, and increased tendency for falls. The aim is to mobilize these patients to avoid the complications of long term in capacitance. The options available for the management of inter trochanteric fractures include extramedullary as well as intramedullary implants. Intramedullary devices appear to have an edge over the extramedullary devices from biomechanics point of view, lowering the forces imposed on the implant due to the shorter lever arm of the fixation. However, previous intramedullary fixation devices, such as the Gamma nail (Howmedica, London, United Kingdom) and Proximal Femoral Nail, (Synthes, Solothurn, Switzerland) resulted in persistent problems including femoral shaft fracture, fixation failure, the Z effect, and distal locking complications often resulting in reoperation with subsequent morbidity and mortality., The proximal femoral nail antirotation, a modification of the Proximal Femoral Nail, uses helical neck blade fixation to obtain high stability to prevent rotation and collapse. The helical blade avoids bone loss that occurs during the drilling and insertion of the standard sliding hip screw. This device allows for improved purchase in the femoral head by radial compaction of the cancellous bone around the blade during insertion. Fixation stability, antirotation, and anti-varus collapse are some of the noted advantages of helical neck blade. However, the proximal diameter of 17 mm is too large for the Asian proximal femur. As a result of which intra and postoperative complications, such as difficulty in insertion, hip and thigh pain, femoral shaft fractures, lateral blade migration, and lateral cortex splitting, have been reported since its introduction among Asian patients., In response to these concerns, the proximal femoral nail antirotation-Asia (PFNA II) was specifically developed by AO/ASIF for Asian patients. Previous studies have demonstrated that the flat lateral shape of the PFNA II is better suited for the femurs of Asian patients by reducing the chances of impingement with the lateral proximal femoral cortex during intraoperative reduction of subtrochanteric fractures.
Halifax nail is an innovative trochanteric nailing system that utilizes a patented tri-wire technology to provide additional rotational stability of the fracture neck of femur. The Halifax nail (GESCO Healthcare) was recently introduced, for fixation of proximal femur fractures with the help of tri-wire made of stainless steel to ensure a good blend of elasticity and fracture rigidity. However, there are no detailed studies comparing the Halifax nail with the AO PFNA.
The aim of the present study was to compare the Halifax nail with the PFNA, to determine if the use of the nail increases operative instrumentation easiness, decreased postoperative pain, improved function, and lowered the postoperative complication rate in patients with intertrochanteric fracture.
| Methods|| |
The study was conducted in a tertiary care center in eastern India. Before the commencement of the study, ethical clearance was obtained from the Institutional Review Board. Informed consent was taken from all patients before their inclusion. The study population constituted of patients presenting to Outdoor and Emergency with proximal femur fractures, from December 2018 to August 2020. The patients with a minimum follow-up of six months after the surgery were included. The above-mentioned authors were the treating physicians in all the cases. All the patients included were above 18 years of age with unstable trochanteric fracture who gave consent for the surgery (with a higher classification as per AO/ASIF).
The patients who had undergone previous hip surgery, with congenital lower limb deformity, showed signs of hip infection, with open or pathological fractures, and those unwilling or unfit for surgery (American Society of Anesthesiologists (ASA) score of V) were excluded from the study.
After initial resuscitation, patients and their family were explained the surgical plan and informed consent was taken. The patients were then subjected for radiographs of pelvis with both hips anteroposterior view and full-length thigh anteroposterior and lateral view and admitted to orthopedic wards while maintaining on skin traction with Bohler-Braun splint awaiting surgery.
Patients' demographic details, side of fracture, fracture anatomy, and mechanism of injury were documented. The fracture was classified based on AO/OTA classification preoperatively. The patients included in the study underwent surgical management of proximal femur fracture with Halifax or PFNA II as randomly allocated.
All the patients were operated on a fracture table in supine position under image intensification. Surgery was performed according to the standard recommended protocols for the PFNA II and Halifax nails. The PFNA II nail used in the current study is a cannulated titanium nail that is 200 mm × 170 mm long and 9, 10, or 11 mm in diameter. The Halifax nail is a cannulated titanium nail with length 180 mm and 200 mm; proximal diameter 15.5 mm; lag screw diameter 10.5 mm; lag screw length 65 mm to 125 mm (5 mm increasing); lag screw angles of 125, 130, and 135 degree; and distal diameter of 5 mm, 10 mm, and 15 mm.
The intraoperative parameters documented were mean operative time, the type of anesthesia, method of reduction (open or close), the nature of the reduction obtained (anatomical, positive, negative) as per Tian et al., intraoperative complications, number of fluoroscopy shots. Patients were discharged after the first postoperative dressing was found satisfactory and number of hospital days were documented. Patients were assessed clinically and radiologically on the 2nd postoperative day, at 2 weeks, 6 weeks, 3 months, and then between 5 and 6 months. Plain anteroposterior and lateral radiographs were obtained at each visit.
At each follow-up, parameters such as hip range of motion; pain in the hip and thigh, postoperative complications, including wound infection and pulmonary, cardiovascular, thromboembolic, renal, and gastrointestinal disorders; fracture complications, including lateral migration of screw, cut out and femoral shaft fracture were noted. Healing was judged by both clinical and radiological criteria, and functional outcome was reviewed according to the Harris Hip score.
Statistical analysis was done using SPSS software (IBM Version-20) (SPSS software version 20 – designed by IBM, New York, USA). Statistical difference between continuous variables was assessed using student's t-test. Categorical variables were compared using Chi-square test. Statistical significance was set at P < 0.05.
| Results|| |
During this study period, 30 patients presented with proximal femur fracture out of which 24 patients were included in the study group.
The mean age of patients in PFNA II and Halifax groups was 72.4 ± 8.7 years and 72.9 ± 7.6 years, respectively, and did not differ significantly (P = 0.887). There was a male preponderance in both the study groups. Other general data were collected from the patients regarding the side of injury type, mechanism of injury, and ASA score (P = 0.156) with regard to preoperative comorbidities [Table 1]. Both treatment groups were comparable in terms of general data preoperatively.
The most frequent fracture type seen in PFNA II group was 31 A2.1 whereas both 31 A2.1 and 31 A2.2 were equally seen in Halifax group.
|Table 1: The Frequency and Percentage Distribution of Pre Operative Parameters|
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Perioperative data are shown in [Table 2]. Open reduction was performed in 5 patients, 3 in the PFNA II group, and 2 in the Halifax group. Mean operative time was significantly longer in the PFNA II group (81.16 min) than in the Halifax group (66.52 min) P = 0.071. Intraoperative fluoroscopy shots were significantly higher in the Halifax group (68.8) than in the PFNA II group (64.2) P = 0.027. Mean hospital stay was 4.83 days in PFNA II group whereas in the Halifax group, it was 4.16 days (P = 0.128). We encountered lateral wall blowout intraoperatively in one patient in the PFNA II group. Encirclage was done and the patient was advised delayed weight bearing.
On postoperative radiographs, fracture reduction was considered anatomical in 11 patients (5 in the PFNA II group and 6 in the Halifax group). Four intraoperative complications were encountered, 3 in the PFNA II group, and 1 in the Halifax group most common being distal interlocking difficulty.
The visual analog scale test was performed for both the groups on the 2nd postoperative day and the most predominant VAS score in both the group was 5 (75% and 42%) as shown in [Figure 1].
|Figure 1: Distribution of visual analog scores of patients in the 2nd postoperative day in both groups|
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Postoperatively, surgical site infection was encountered in one patient. It was managed with early debridement, intravenous antibiotics as per culture sensitivity report, and local antibiotic instillation. Migration of hip screw was managed with nonweight bearing and removal of the screw after 6 months from the index surgery. Further planning was done based on the intraoperative findings and the progress of union. Screw cutout was managed with implant removal after fracture union.
There were no peri-implant fractures or implant breakage in the two groups. There were 5 cases of delayed union (3 in PFNA and 2 in Halifax group), however, they did not require any second intervention as radiographic union was seen before the end of the study period. All the above cases were associated with osteoporosis. The incidence of cut out or migration of hip screw did not differ significantly between the two groups (P = 0.552) [Figure 2]. Six patients experienced hip pain (4 in PFNA II group and 2 in Halifax group).
|Figure 2: A middle-aged male patient who underwent PFNA II nailing for intertrochanteric fracture. (a) Immediate postoperative radiograph. (b) Radiograph was taken 6-week postintervention demonstrating medial migration of the helical blade|
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The functional status of the patients was evaluated using Harris hip score at 2 weeks, 6 weeks, 16 weeks, and 24 weeks postoperatively and was categorized according to their grades. The results are tabulated in [Table 3]a and [Table 3]b. The score improved by 13.3% from 2 weeks to 24 weeks postoperatively in PFNA II group and by 14.9% in the Halifax group. However, the difference in improvement was found to have no statistical significance.
Case illustrations are given in [Figure 3], [Figure 4], [Figure 5], [Figure 6].
|Figure 3: A 35-year-old male patient with intertrochanteric fracture. Preoperative radiograph|
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|Figure 4: A 35-year-old male patient with intertrochanteric fracture fixed with Halifax nail. Postoperative radiograph day 2|
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|Figure 5: A 35-year-old male patient with intertrochanteric fracture fixed with Halifax nail. Postoperative radiograph– 6 months|
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|Figure 6: A 35-year-old male patient with intertrochanteric fracture fixed with Halifax nail. Clinical photograph – 6-month postsurgery|
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| Discussion|| |
Lately, due to the increasing life expectancy of the elderly population, the incidence of extra-capsular hip fractures has been witnessing an increasing trend. The poor bone quality in this group of patients requires the choice of a fixation device that can increase stability and keep surgical complications to a minimum.
The present study had a mean operative time of 66.52 min, in the Halifax group, 16 min longer than that reported by Sharma et al. at 40 min. This may be associated with fracture type warranting repeated reduction and manipulation leading to increased operative and fluoroscopy time and intraoperative blood loss, especially in more unstable fracture types (AO/ASIF 31-A2.3 and 31-A3.3). This problem is frequently seen in short, elderly women, especially those with osteoporosis.
Although the percentage of patients having better VAS scores was marginally higher in Halifax group, no significant differences existed in final functional outcomes between the two groups.
The Harris hip scoring system was used in assessing the functional outcome of both the nailing groups. It is a joint-specific outcome measure to compare the functional status of the hip following trauma. Min et al. and Sharma et al. utilized the score to compare the outcome of the management of unstable intertrochanteric fracture with PFN nail with gamma nail and PFN and PFNA, respectively. They also reported no significant difference in the outcome among the procedures.
Calvert in his studies found gamma nail to be better for the management of complex per trochanteric fractures with subtrochanteric extension. Various other studies found favorable results with gamma nail in managing a greater variety of hip fractures with a less invasive technique and with better results.
When reaming is not enough for inserting the nail, the lateral cortex of the proximal femur may split as the nail is hammered into the marrow cavity. In the current study, this complication occurred in 1 patient, in PFNA II group. In addition, perfect implant position cannot always be achieved because it is difficult to insert the nail completely into the cavity even when the lateral wall becomes thin after repeated reaming. Hip and thigh pain is a commonly encountered complaint in the postoperative period, however, it has been found to not impact the final functional outcome., It has been attributed to gluteus medius tendon damage and chronic muscle injury caused by the over-long proximal end of the nail protruding into the great trochanter. In the present study, it was reported in 4/12 patients in PFNA II group and 2/12 patients in Halifax group.
The most common postoperative complications that lead to surgical failure in intertrochanteric fractures are varus collapse of the head and neck caused by lag screw cutout or lateral protrusion.
Migration of the helical blade leading to perforation into the hip joint without loss of reduction was found in one of our cases belonging to PFNA II Group 3 months after surgery. Although rare, this complication has been reported before by Brunner et al. and Simmermacher et al. and has been attributed to loosening of the locking mechanism due to cyclical loading and failure of the blade to slide laterally.
The lag screw is rotationally unstable within the bone when using a single lag screw, flexion-extension of the limb results in loosening of the bone-screw interface, with the screw secondarily cutting out. Biomechanical studies and clinical reports have demonstrated that the PFNA II and Halifax nails have good antirotation performance. Although other devices, such as the proximal femoral nail, feature 2 separate screws placed into the head-and-neck fragments in a reconstruction mode and tend to resist rotation of the head-and-neck segment during hip motion, these devices are associated with the Z effect where the superior screw bears a disproportionate amount of load during weight bearing. A previous study suggested that excessive shortening of the neck (more than 5 mm) may cause weakness in the gluteus medius and limit hip joint movement. There was equal incidence of varus malunion and no requirement of reoperation in both the groups.
| Conclusion|| |
This study compared the clinical outcomes of the PFNA II and Halifax nails. The results suggest that mean operative time was greater in the PFNA II group. Although intraoperative complications were comparable between the groups, the PFNA II nail was more likely to cause a distal lock problem after insertion. Harris hip scores and cutout rates were comparable between the groups, but the rate of hip pain was lower in the Halifax group.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initial s will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3]