- Email: [email protected]
The Asia proximal femoral nail antirotation versus the standard proximal femoral antirotation nail for unstable intertrochanteric fractures in elderly Chinese patients
Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146
Available online at
ScienceDirect www.sciencedirect.com
Original article
The Asia proximal femoral nail antirotation versus the standard proximal femoral antirotation nail for unstable intertrochanteric fractures in elderly Chinese patients J. Li 1 , L. Cheng 1 , J. Jing ∗ Department of Orthopaedics, The Second Hospital of Anhui Medical University, 678, Furong Avenue, Hefei, Anhui 230601, PR China
a r t i c l e
i n f o
Article history: Received 5 May 2014 Accepted 17 December 2014 Keywords: PFNA PFNA-II Unstable intertrochanteric fractures Chinese
a b s t r a c t Background: The best options of internal fixation for unstable intertrochanteric fractures in elderly Chinese patients remain controversial. The Asia proximal femoral nail antirotation (PFNA-II) was specifically designed for Asian patients, which could be more effective than the regular proximal femoral nail antirotation (PFNA). Compared to PFNA, whether PFNA-II is associated with shorter operative time and lower rates of complications is unknown. Hypothesis: The rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation using PFNA-II is quicker. Materials and methods: Between June 2008 and December 2011, 188 patients with unstable intertrochanteric fractures treated with the PFNA-II (n = 118) or PFNA (n = 70) were retrospectively evaluated. Follow-up evaluations were performed at 1, 3, 6, 9 and 12 months, and every year thereafter. According to residual valgus-varus deformation, the quality of the fracture reduction was graded as poor (>10◦ deformation), acceptable (5◦ to 10◦ deformation), or good (<5◦ deformation). The operative time, intraoperative blood loss, overall time of fluoroscopy, blood transfusion volume, postoperative drainage, length of hospital stay and postoperative complications were recorded. Results: The mean operative time in the PFNA-II group was significantly shorter than that in the PFNA group (66.25 ± 13.15 vs 79.50 ± 21.12 minutes; P < 0.05), intraoperative blood loss was smaller (131.86 ± 69.16 vs 162.14 ± 66.18 mL; P < 0.05), and fewer local complications were observed (25% vs 46%; P < 0.05). There was no significant difference in the postoperative blood transfusions, overall time of fluoroscopy, postoperative drainage, length of hospital stay, fracture reduction, the position of the implant and tip apex distance between the two groups. At follow-up, no significant difference was found between the two groups in Harris hip score (HHS) (86.19 ± 6.53 vs 85.27 ± 5.47; P > 0.05), visual analogue scale (VAS) (0.87 ± 0.85 vs 0.97 ± 0.87; P > 0.05). Discussion: Due to its special design for the Asian population, PFNA-II offers a better match with the Chinese people’s proximal femur anatomic structure. This study showed that the rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation time is shorter. Level of evidence: Level III, case control study. © 2015 Elsevier Masson SAS. All rights reserved.
1. Introduction Intertrochanteric fractures are relatively common among the elderly, 90% of such fractures occurring in persons aged over 65 years [1]. Most elderly patients with intertrochanteric
∗ Corresponding author. E-mail address: [email protected] (J. Jing). 1 Jun Li and Li Cheng contributed equally to this work. http://dx.doi.org/10.1016/j.otsr.2014.12.011 1877-0568/© 2015 Elsevier Masson SAS. All rights reserved.
fractures have osteoporosis [2]. This type of geriatric fracture has a relatively high mortality and causes severe impairment of function [3]. Common treatment options for Chinese patients include intramedullary nailing with either the proximal femoral nail antirotation or Asia proximal femoral nail antirotation, both of which represent the most commonly used implants for the treatment of unstable intertrochanteric fractures [4–8]. The proximal femoral nail antirotation (PFNA) was used in clinic for the first time in 2004. It is an original intramedullary device which contain a helical blade inserted by impaction to result in bone
144
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146
compaction around the blade to retard rotation and varus collapse [9]. Several studies showed few complications and positive results with PFNA for unstable intertrochanteric fractures [10–12]. However, the proximal end of the nail was not matched with the specific anatomy of some short elderly patients. Further modifications of the nail are necessary for the elderly Chinese population, intra- and postoperative complications, such as difficulty inserting it, pain in the hip and thigh, lateral blade migration, femoral shaft fracture, and lateral cortex splitting intraoperatively, have been reported since it began being used in Asian patients [4,13]. In response to these concerns, AO/ASIF developed the Asia proximal femoral nail antirotation (PFNA-II) specifically for Asian patients. Although both nails have been reported to have good clinical outcomes, no study has compared the outcomes of the PFNA and PFNA-II. Therefore, we conducted a case control study to assess if the PFNA-II was associated with shorter operative time and lower rates of complications. We hypothesized that the rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation using PFNAII is quicker. 2. Patients and methods 2.1. Patients From June 2008 to December 2011, all patients with unstable intertrochanteric fractures were treated with a PFNA or a PFNA-II (Synthes GmbH, Oberdorf, Switzerland) in our hospital. The study was approved by the Ethics Committee of The Second Hospital of Anhui Medical University. All patients have provided their written informed consent to participate in this study. We did not conduct our clinical investigations outside of our country of residence. The PFNA or PFNA-II was chosen according to surgeon preference and availability of the device. Patients eligible for the study were at least 60 years of age. Exclusion criteria included pathological intertrochanteric fractures, open fractures, multiple fractures, presence of degenerative osteoarthritis/arthritis in the injured hip and severe concomitant medical condition (grade V on the American Society of Anesthesiologists [ASA] scale) [14]. All the patients’ records, including gender, age, body mass index (BMI), ASA class rating and fracture type according to AO/OTA classification, were complete. 2.2. Surgery and rehabilitation Surgery was carried out under general anaesthesia. A fracture table and image intensifier were used in all cases. The PFNA was inserted without diaphyseal reaming, which was a solid titanium nail 170, 200 or 240 mm in length and 10 or 11 mm in diameter. The helical blade which attached to a particular inserter was introduced over the guide wire with hammer. While the introduction was finished, the helical blade could be fixed to prevent rotation. The PFNA could be distally fixed either statically or dynamically. Somewhat differently, the PFNA-II nail used in the study is a solid titanium nail that is 170 or 200 mm long and 9, 10, or 11 mm in diameter. The surgical procedure was the same as the one used for the standard PFNA [6,10]. Postoperatively, analgesic care and diet were related to local standards and equal for both groups. Antithrombotic prophylaxis was administered using low-molecular-weight heparin (Lovenox 40 mg) for 3–5 days, and all patients received prophylactic antibiotics (Cefotiam 4.0 g) for 3 days. As the importance of rehabilitation, patients were encouraged to move the hip, knee and ankle joints on the first postoperative day and partial weight bearing was allowed with the aid of crutches on the following day.
Fig. 1. A: anteroposterior hip radiographs of intertrochanteric fracture treated with PFNA. B: anteroposterior hip radiographs of intertrochanteric fracture treated with PFNA-II.
2.3. Method of assessment Follow-up evaluations were performed at 1, 3, 6, 9 and 12 months, and every year thereafter. The operative time, blood loss during surgery, amount of transfused blood, overall fluoroscopy time, postoperation drainage, duration of hospitalization, postoperative complications, and assessment of nail handling for Asia proximal femoral nail antirotation were compared with those of proximal femoral nail antirotation. Plain anteroposterior and lateral radiographs were obtained at each visit (Fig. 1). At the last follow-up, the degree of pain was measured by visual analogue scale (VAS) and the functional outcome was evaluated on the basis of Harris Hip Score (HHS) [15]. The radiographs of affected hip were achieved in the AP. The mediolateral planes at every follow-up visit, the extent of fracture and any changes in the position of the implant were noted. The quality of the fracture reduction was graded as poor (>10◦ varus/valgus), acceptable (5◦ –10◦ varus/valgus), or good (<5◦ varus/valgus). The position of the implant was graded as optimal if the blade was placed into the centre of the neck on a lateral view and lower half on a AP view [6]. Which was graded as suboptimal if the blade was not placed into the centre of the neck on a lateral view or lower half on a AP view. 2.4. Statistical analysis Statistical analysis was performed using SPSS statistical package, version 16.0 (SPSS Inc., Chicago, IL, USA) for Windows. Quantitative variables were analysed using the Student’s t-test and categorical variables were analysed by the 2 test or Fisher’s exact test where appropriate. The level of statistical significance was set at a two-sided P-value of 0.05. 3. Results Between June 2008 and December 2011, 188 elderly Chinese patients with unstable intertrochanteric fractures were treated
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146 Table 1 Patient demographics.
Man: woman Age (y) BMI Side (left/right) Injury mechanism Fall at home Traffic accident AO type of fracture 31A2 31A3 ASA classification ASA 1 ASA 2 ASA 3 ASA 4 Follow-up (months)
145
Table 3 Postoperative complications. PFNA-II
PFNA
P
52:66 67.42 ± 16.40 (60–98) 22.49 ± 3.88 (13.89–34.65) 58:60
32:38 66.31 ± 16.44 (60–88) 22.94 ± 3.56 (16.69–34.19) 34:36
0.88 0.655
82 36
50 20
98 20
55 15
15 48 45 10 29.08 ± 9.07 (12–36)
14 26 22 8 29.49 ± 9.29 (12–36)
0.425 0.939 0.779
0.446
0.456
Systemic complications Pneumonia Cardiovascular disorder Urinary tract infection Hypoproteinemia Deep vein thrombosis Pressure sore Local complications Superficial infection Deep infection Fat liquefaction Haematoma Cutout Thigh pain
PFNA-II
PFNA
P-value
28 3 4 5 10 1 5 29 2 1 8 10 0 8
19 3 2 3 6 1 4 32 1 1 5 5 2 18
0.728 0.819 1 1 1 1 0.916 0.004 1 1 1 0.745 0.267 0
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation. 0.772
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation; BMI: body mass index; ASA: American Society of Anesthesiologists.
with PFNA (n = 70) or PFNA-II (n = 118). No significant differences were found between the two groups in gender, age, BMI, side of fracture, type of fracture, ASA score and follow-up time (Table 1). The mean surgical time in the PFNA-II group was 66 min and was significantly shorter than that in the PFNA group, in which the mean time was 79 min (P < 0.05) (Table 2). Blood loss was significantly less than in the PFNA-II group than that in the PFNA group (P < 0.05). There was no significant difference in amount of transfused blood, overall fluoroscopy time, postoperation drainage and duration of hospitalization between the two groups (P > 0.05) (Table 2). Fracture reduction was considered good or acceptable in 181 patients (113 in the PFNA-II group, 68 in the PFNA group) on postoperative radiographs. The position of the implant was optimal in 155 patients (102 in the PFNA-II group, 53 in the PFNA group). The mean tip apex distance was 19.25 mm in the PFNA-II group and 19.04 mm in the PFNA group. There was no significant difference between the two groups in fracture reduction, the position of the implant and tip apex distance (P > 0.05) (Table 2). In our study, six main postoperative systemic complications occurred, including pneumonia, cardiovascular disorder, urinary tract infection, hypoproteinemia, deep vein thrombosis and pressure sore. No significant difference was found between the two groups in systemic complications. Two cutouts occurred in the PFNA group, but none occurred in the PFNA-II group. Several patients reported thigh pain during the follow-up period: 8 patients in the PFNA-II group and 18 in the PFNA group (P < 0.05). In the
Table 4 Outcome of follow-up according to Harris and visual analogue scale.
HHS VAS Mortality (%)
PFNA-II
PFNA
P-value
86.19 ± 6.53 (58–93) 0.87 ± 0.85 (0–3) 7
85.27 ± 5.47 (66–93) 0.97 ± 0.87 (0–3) 6
0.326 0.448 0.557
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation; HHS: Harris Hip Score; VAS: visual analogue scale.
PFNA-II group, fewer local complications were observed (P < 0.05) (Table 3). The mean HHS was 86.19 in the PFNA-II group and 85.27 in the PFNA group, and the mean VAS was 0.87 in the former and 0.97 in the latter group. The mortality rate at one year was 7% in the PFNA-II group, compared with 6% in the PFNA group. No significant difference was found between the two groups in HHS, VAS and the one-year mortality rate (P > 0.05) (Table 4). 4. Discussion In the present study, we compared PFNA and PFNA-II for the treatment of unstable intertrochanteric fractures in elderly Chinese patients. Our results suggested that the rate of complications using PFNA-II was lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation time was shorter. A weakness of this study is that the operations were performed by different surgeons, however, a single observer collected data and the surgical procedure was the same. The study design was a
Table 2 Operative records of patients.
Operation time (min) Blood loss (mL) Blood transfusion (U) Fluoroscopy time (s) Postoperation drainage (mL) Hospitalization duration (d) Fracture reduction Good Acceptable Poor The position of implant Optimal Suboptimal Tip apex distance (mm)
PFNA-II
PFNA
P-value
66.25 ± 13.15 (43–128) 131.86 ± 69.16 (30–300) 2.37 ± 0.88 (1–4) 87.36 ± 21.80 (25–200) 68.56 ± 26.34 (20–200) 10.81 ± 3.28 (6–16)
79.50 ± 21.12 (49–142) 162.14 ± 66.18 (100–350) 2.75 ± 0.87 (1–4) 87.64 ± 13.41 (60–121) 71.34 ± 21.61 (30–150) 10.30 ± 2.56 (6–15)
0 0.004 0.221 0.921 0.456 0.234 0.775
93 20 5
58 10 2
102 16 19.25 ± 4.71 (9–36)
53 17 19.04 ± 4.70 (10–31)
0.075
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation.
0.766
146
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146
retrospective design; the two groups were comparable according to major variables (gender, age, BMI, side of fracture, type of fracture, ASA score and follow-up time). However, a randomized, prospective study is needed in the future to further confirm the current findings. Intertrochanteric fractures is one among the most common injuries in the elderly population, and patients’ quality of life is affected significantly [16–19]. The goal of treating these osteoporotic fractures is the same as for other hip fractures: to decrease pain and to restore the patient’s walking ability to the pre-injury level [20,21]. The treatment of unstable intertrochanteric fractures remains challenging to orthopedic surgeons, because of old age and poor bone quality [22–24]. Moreover, the ideal treatment for unstable intertrochanteric fractures in elderly patients remains controversial [25–27]. The proximal femoral nailing (PFN) has been widely used in the unstable intertrochanteric fractures [28]. The AO/ASIF group further modified PFN to the PFNA to ameliorate the angular and rotational stability with one single element. It is an intramedullary device with a helical blade rather than a screw for better purchase in the femoral head and was tested in a clinical study [10]. Because of the height in Asian population on average is less than that of Americans or Europeans, the femoral neck diameter and proximal femoral length are relatively shorter [29]. The standard proximal femoral nail antirotation nail has a mediolateral angle of 6◦ and a proximal diameter of 17 mm. To insert the nail, a much larger femoral canal needs to be prepared to accommodate the nail of the given diameter [30]. This means that a mass of cortical bone has to be reamed, thus weakening the osteoporotic bone in most patients. The study shows that the necessary over reaming of the shaft weakens the entire shaft, and that reaming of the medulla can result in increased blood loss [31,32]. Moreover, this geometric mismatch between the proximal end of the nail and proximal femur is the most probable cause of the intraoperative complications of jamming and fracturing of the lateral cortex. The PFNA-II was designed to avoid these problems, which was designed to have a mediolateral angle of 5◦ and a proximal diameter of 16.5 mm. The modified nail has a considerably better anatomic fit. This effectively decreases the hoop stress inside the femoral shaft and may have led to a significant decrease in intraoperative and postoperative diaphyseal fractures [33]. Unstable intertrochanteric fractures were treated successfully with the PFNA or PFNA-II in elderly Chinese patients. However, PFNA-II is superior to PFNA in terms of surgical time, intraoperative blood loss, and postoperative complications in elderly Chinese patients. Further study is needed to confirm these early results. Disclosure of interest The authors declare that they have no conflicts of interest concerning this article. References [1] Stevens JA, Olson S. Reducing falls and resulting hip fractures among older women. MMWR Recomm Rep 2000;49:3–12. [2] Felson DT, Anderson JJ, Hannan MT, Milton RC, Wilson PW, Kiel DP. Impaired vision and hip fracture. The Framingham Study. J Am Geriatr Soc 1989;37:495–500. [3] Tong P, Jin H, Shen Y, et al. Research of You Gui Yin and MSCs interventional therapy on early avascular necrosis of the femoral head. Zhong guo Xiu Fu Chong Jian Wai Ke Za Zhi 2009;23:456–62. [4] Pu JS, Liu L, Wang GL, Fang Y, Yang TF. Results of the proximal femoral nail anti-rotation (PFNA) in elderly Chinese patients. Int Orthop 2009;33:1441–4.
[5] Zhang S, Zhang K, Jia Y, Yu B, Feng W. Intertan nail versus proximal femoral nail antirotation-Asia in the treatment of unstable trochanteric fractures. Orthopedics 2013;36:e288–94. [6] Lv C, Fang Y, Liu L, et al. The new proximal femoral nail antirotation-Asia: early results. Orthopedics 2011;34:18–23. [7] Yang YH, Wang YR, Jiang SD, Jiang LS. Proximal femoral nail antirotation and third-generation Gamma nail: which is a better device for the treatment of intertrochanteric fractures? Singapore Med J 2013;54:446–50. [8] Shen L, Zhang Y, Shen Y, Cui Z. Antirotation proximal femoral nail versus dynamic hip screw for intertrochanteric fractures: a meta-analysis of randomized controlled studies. Orthop Traumatol Surg Res 2013;99:377–83. [9] Mereddy P, Kamath S, Ramakrishnan M, Malik H, Donnachie N. The AO/ASIF proximal femoral nail antirotation (PFNA): a new design for the treatment of unstable proximal femoral fractures. Injury 2009;40:428–32. [10] Simmermacher RK, Ljungqvist J, Bail H, et al. The new proximal femoral nail antirotation (PFNA) in daily practice: results of a multicentre clinical study. Injury 2008;39:932–9. [11] Garg B, Marimuthu K, Kumar V, Malhotra R, Kotwal PP. Outcome of short proximal femoral nail antirotation and dynamic hip screw for fixation of unstable trochanteric fractures. A randomised prospective comparative trial. Hip Int 2011;21:531–6. [12] Xu YZ, Geng DC, Mao HQ, Zhu XS, Yang HL. A comparison of the proximal femoral nail antirotation device and dynamic hip screw in the treatment of unstable pertrochanteric fracture. J Int Med Res 2010;38:1266–75. [13] Yaozeng X, Dechun G, Huilin Y, Guangming Z, Xianbin W. Comparative study of trochanteric fracture treated with the proximal femoral nail anti-rotation and the third generation of gamma nail. Injury 2010;41:1234–8. [14] ASA Physical Status Classification System. American Society of Anesthesiologists, 1963, http://www.asahq.org/clinical/physicalstatus.htm [15] Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am 1969;51:737–55. [16] Babst R, Renner N, Biedermann M, et al. Clinical results using the trochanter stabilizing plate (TSP): the modular extension of the dynamic hip screw (DHS) for internal fixation of selected unstable intertrochanteric fractures. J Orthop Trauma 1998;12:392–9. [17] Kenzora JE, McCarthy RE, Lowell JD, Sledge CB. Hip fracture mortality. Relation to age, treatment, preoperative illness, time of surgery, and complications. Clin Orthop Relat Res 1984;86:45–56. [18] Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ. Mortality following hip fracture: trends and geographical variations over the last 40 years. Injury 2008;39:1157–63. [19] Richmond J, Aharonoff GB, Zuckerman JD, Koval KJ. Mortality risk after hip fracture. J Orthop Trauma 2003;17:S2–5. [20] Bosch U, Schreiber T, Krettek C. Reduction and fixation of displaced intracapsular fractures of the proximal femur. Clin Orthop Relat Res 2002;399:59–71. [21] Lorich DG, Geller DS, Nielson JH. Osteoporotic pertrochanteric hip fractures: management and current controversies. Instr Course Lect 2004;53:441–54. [22] Zhang B, Chiu KY, Wang M. Hip arthroplasty for failed internal fixation of intertrochanteric fractures. J Arthroplasty 2004;19:329–33. [23] Hsu CJ, Chou WY, Chiou CP, Chang WN, Wong CY. Hemi-arthroplasty with supplemental fixation of greater trochanter to treat failed hip screws of femoral intertrochanteric fracture. Arch Orthop Trauma Surg 2008;128:841–5. [24] Haidukewych GJ, Berry DJ. Hip arthroplasty for salvage of failed treatment of intertrochanteric hip fractures. J Bone Joint Surg Am 2003;85:899–904. [25] Little NJ, Verma V, Fernando C, Elliott DS, Khaleel A. A retrospective trial comparing the Holland nail with the dynamic hip screw in the treatment of intertrochanteric fractures of the hip. J Bone Joint Surg Br 2008;90:1073–8. [26] Anglen JO, Weinstein JN. Nail or plate fixation of intertrochanteric hip fractures: changing pattern of practice. A review of the American Board of Orthopaedic Surgery Database. J Bone Joint Surg Am 2008;90:700–7. [27] Aros B, Tosteson AN, Gottlieb DJ, Koval KJ. Is a sliding hip screw or im nail the preferred implant for intertrochanteric fracture fixation? Clin Orthop Relat Res 2008;466:2827–32. [28] Windolf J, Hollander DA, Hakimi M, Linhart W. Proximal femoral nail (PFN): pitfalls and complications in the use of the proximal femoral nail. Langenbecks Arch Surg 2005;390:59–65. [29] Leung KS, Procter P, Robioneck B, Behrens K. Geometric mismatch of the Gamma nail to the Chinese femur. Clin Orthop Relat Res 1996;323:42–8. [30] Menezes DF, Gamulin A, Noesberger B. Is the proximal femoral nail a suitable implant for treatment of all trochanteric fractures? Clin Orthop Relat Res 2005;439:221–7. [31] Friedl W, Colombo-Benkmann M, Dockter S, Machens HG, Mieck U. Gamma nail osteosynthesis of per- and subtrochanteric femoral fractures. 4 years experiences and their consequences for further implant development. Chirurg 1994;65:953–63. [32] Pratt DJ, Papagiannopoulos G, Rees PH, Quinnell R. The effects of medullary reaming on the torsional strength of the femur. Injury 1987;18:177–9. [33] Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury 1992;23:291–2.
Available online at
ScienceDirect www.sciencedirect.com
Original article
The Asia proximal femoral nail antirotation versus the standard proximal femoral antirotation nail for unstable intertrochanteric fractures in elderly Chinese patients J. Li 1 , L. Cheng 1 , J. Jing ∗ Department of Orthopaedics, The Second Hospital of Anhui Medical University, 678, Furong Avenue, Hefei, Anhui 230601, PR China
a r t i c l e
i n f o
Article history: Received 5 May 2014 Accepted 17 December 2014 Keywords: PFNA PFNA-II Unstable intertrochanteric fractures Chinese
a b s t r a c t Background: The best options of internal fixation for unstable intertrochanteric fractures in elderly Chinese patients remain controversial. The Asia proximal femoral nail antirotation (PFNA-II) was specifically designed for Asian patients, which could be more effective than the regular proximal femoral nail antirotation (PFNA). Compared to PFNA, whether PFNA-II is associated with shorter operative time and lower rates of complications is unknown. Hypothesis: The rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation using PFNA-II is quicker. Materials and methods: Between June 2008 and December 2011, 188 patients with unstable intertrochanteric fractures treated with the PFNA-II (n = 118) or PFNA (n = 70) were retrospectively evaluated. Follow-up evaluations were performed at 1, 3, 6, 9 and 12 months, and every year thereafter. According to residual valgus-varus deformation, the quality of the fracture reduction was graded as poor (>10◦ deformation), acceptable (5◦ to 10◦ deformation), or good (<5◦ deformation). The operative time, intraoperative blood loss, overall time of fluoroscopy, blood transfusion volume, postoperative drainage, length of hospital stay and postoperative complications were recorded. Results: The mean operative time in the PFNA-II group was significantly shorter than that in the PFNA group (66.25 ± 13.15 vs 79.50 ± 21.12 minutes; P < 0.05), intraoperative blood loss was smaller (131.86 ± 69.16 vs 162.14 ± 66.18 mL; P < 0.05), and fewer local complications were observed (25% vs 46%; P < 0.05). There was no significant difference in the postoperative blood transfusions, overall time of fluoroscopy, postoperative drainage, length of hospital stay, fracture reduction, the position of the implant and tip apex distance between the two groups. At follow-up, no significant difference was found between the two groups in Harris hip score (HHS) (86.19 ± 6.53 vs 85.27 ± 5.47; P > 0.05), visual analogue scale (VAS) (0.87 ± 0.85 vs 0.97 ± 0.87; P > 0.05). Discussion: Due to its special design for the Asian population, PFNA-II offers a better match with the Chinese people’s proximal femur anatomic structure. This study showed that the rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation time is shorter. Level of evidence: Level III, case control study. © 2015 Elsevier Masson SAS. All rights reserved.
1. Introduction Intertrochanteric fractures are relatively common among the elderly, 90% of such fractures occurring in persons aged over 65 years [1]. Most elderly patients with intertrochanteric
∗ Corresponding author. E-mail address: [email protected] (J. Jing). 1 Jun Li and Li Cheng contributed equally to this work. http://dx.doi.org/10.1016/j.otsr.2014.12.011 1877-0568/© 2015 Elsevier Masson SAS. All rights reserved.
fractures have osteoporosis [2]. This type of geriatric fracture has a relatively high mortality and causes severe impairment of function [3]. Common treatment options for Chinese patients include intramedullary nailing with either the proximal femoral nail antirotation or Asia proximal femoral nail antirotation, both of which represent the most commonly used implants for the treatment of unstable intertrochanteric fractures [4–8]. The proximal femoral nail antirotation (PFNA) was used in clinic for the first time in 2004. It is an original intramedullary device which contain a helical blade inserted by impaction to result in bone
144
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146
compaction around the blade to retard rotation and varus collapse [9]. Several studies showed few complications and positive results with PFNA for unstable intertrochanteric fractures [10–12]. However, the proximal end of the nail was not matched with the specific anatomy of some short elderly patients. Further modifications of the nail are necessary for the elderly Chinese population, intra- and postoperative complications, such as difficulty inserting it, pain in the hip and thigh, lateral blade migration, femoral shaft fracture, and lateral cortex splitting intraoperatively, have been reported since it began being used in Asian patients [4,13]. In response to these concerns, AO/ASIF developed the Asia proximal femoral nail antirotation (PFNA-II) specifically for Asian patients. Although both nails have been reported to have good clinical outcomes, no study has compared the outcomes of the PFNA and PFNA-II. Therefore, we conducted a case control study to assess if the PFNA-II was associated with shorter operative time and lower rates of complications. We hypothesized that the rate of complications using PFNA-II is lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation using PFNAII is quicker. 2. Patients and methods 2.1. Patients From June 2008 to December 2011, all patients with unstable intertrochanteric fractures were treated with a PFNA or a PFNA-II (Synthes GmbH, Oberdorf, Switzerland) in our hospital. The study was approved by the Ethics Committee of The Second Hospital of Anhui Medical University. All patients have provided their written informed consent to participate in this study. We did not conduct our clinical investigations outside of our country of residence. The PFNA or PFNA-II was chosen according to surgeon preference and availability of the device. Patients eligible for the study were at least 60 years of age. Exclusion criteria included pathological intertrochanteric fractures, open fractures, multiple fractures, presence of degenerative osteoarthritis/arthritis in the injured hip and severe concomitant medical condition (grade V on the American Society of Anesthesiologists [ASA] scale) [14]. All the patients’ records, including gender, age, body mass index (BMI), ASA class rating and fracture type according to AO/OTA classification, were complete. 2.2. Surgery and rehabilitation Surgery was carried out under general anaesthesia. A fracture table and image intensifier were used in all cases. The PFNA was inserted without diaphyseal reaming, which was a solid titanium nail 170, 200 or 240 mm in length and 10 or 11 mm in diameter. The helical blade which attached to a particular inserter was introduced over the guide wire with hammer. While the introduction was finished, the helical blade could be fixed to prevent rotation. The PFNA could be distally fixed either statically or dynamically. Somewhat differently, the PFNA-II nail used in the study is a solid titanium nail that is 170 or 200 mm long and 9, 10, or 11 mm in diameter. The surgical procedure was the same as the one used for the standard PFNA [6,10]. Postoperatively, analgesic care and diet were related to local standards and equal for both groups. Antithrombotic prophylaxis was administered using low-molecular-weight heparin (Lovenox 40 mg) for 3–5 days, and all patients received prophylactic antibiotics (Cefotiam 4.0 g) for 3 days. As the importance of rehabilitation, patients were encouraged to move the hip, knee and ankle joints on the first postoperative day and partial weight bearing was allowed with the aid of crutches on the following day.
Fig. 1. A: anteroposterior hip radiographs of intertrochanteric fracture treated with PFNA. B: anteroposterior hip radiographs of intertrochanteric fracture treated with PFNA-II.
2.3. Method of assessment Follow-up evaluations were performed at 1, 3, 6, 9 and 12 months, and every year thereafter. The operative time, blood loss during surgery, amount of transfused blood, overall fluoroscopy time, postoperation drainage, duration of hospitalization, postoperative complications, and assessment of nail handling for Asia proximal femoral nail antirotation were compared with those of proximal femoral nail antirotation. Plain anteroposterior and lateral radiographs were obtained at each visit (Fig. 1). At the last follow-up, the degree of pain was measured by visual analogue scale (VAS) and the functional outcome was evaluated on the basis of Harris Hip Score (HHS) [15]. The radiographs of affected hip were achieved in the AP. The mediolateral planes at every follow-up visit, the extent of fracture and any changes in the position of the implant were noted. The quality of the fracture reduction was graded as poor (>10◦ varus/valgus), acceptable (5◦ –10◦ varus/valgus), or good (<5◦ varus/valgus). The position of the implant was graded as optimal if the blade was placed into the centre of the neck on a lateral view and lower half on a AP view [6]. Which was graded as suboptimal if the blade was not placed into the centre of the neck on a lateral view or lower half on a AP view. 2.4. Statistical analysis Statistical analysis was performed using SPSS statistical package, version 16.0 (SPSS Inc., Chicago, IL, USA) for Windows. Quantitative variables were analysed using the Student’s t-test and categorical variables were analysed by the 2 test or Fisher’s exact test where appropriate. The level of statistical significance was set at a two-sided P-value of 0.05. 3. Results Between June 2008 and December 2011, 188 elderly Chinese patients with unstable intertrochanteric fractures were treated
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146 Table 1 Patient demographics.
Man: woman Age (y) BMI Side (left/right) Injury mechanism Fall at home Traffic accident AO type of fracture 31A2 31A3 ASA classification ASA 1 ASA 2 ASA 3 ASA 4 Follow-up (months)
145
Table 3 Postoperative complications. PFNA-II
PFNA
P
52:66 67.42 ± 16.40 (60–98) 22.49 ± 3.88 (13.89–34.65) 58:60
32:38 66.31 ± 16.44 (60–88) 22.94 ± 3.56 (16.69–34.19) 34:36
0.88 0.655
82 36
50 20
98 20
55 15
15 48 45 10 29.08 ± 9.07 (12–36)
14 26 22 8 29.49 ± 9.29 (12–36)
0.425 0.939 0.779
0.446
0.456
Systemic complications Pneumonia Cardiovascular disorder Urinary tract infection Hypoproteinemia Deep vein thrombosis Pressure sore Local complications Superficial infection Deep infection Fat liquefaction Haematoma Cutout Thigh pain
PFNA-II
PFNA
P-value
28 3 4 5 10 1 5 29 2 1 8 10 0 8
19 3 2 3 6 1 4 32 1 1 5 5 2 18
0.728 0.819 1 1 1 1 0.916 0.004 1 1 1 0.745 0.267 0
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation. 0.772
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation; BMI: body mass index; ASA: American Society of Anesthesiologists.
with PFNA (n = 70) or PFNA-II (n = 118). No significant differences were found between the two groups in gender, age, BMI, side of fracture, type of fracture, ASA score and follow-up time (Table 1). The mean surgical time in the PFNA-II group was 66 min and was significantly shorter than that in the PFNA group, in which the mean time was 79 min (P < 0.05) (Table 2). Blood loss was significantly less than in the PFNA-II group than that in the PFNA group (P < 0.05). There was no significant difference in amount of transfused blood, overall fluoroscopy time, postoperation drainage and duration of hospitalization between the two groups (P > 0.05) (Table 2). Fracture reduction was considered good or acceptable in 181 patients (113 in the PFNA-II group, 68 in the PFNA group) on postoperative radiographs. The position of the implant was optimal in 155 patients (102 in the PFNA-II group, 53 in the PFNA group). The mean tip apex distance was 19.25 mm in the PFNA-II group and 19.04 mm in the PFNA group. There was no significant difference between the two groups in fracture reduction, the position of the implant and tip apex distance (P > 0.05) (Table 2). In our study, six main postoperative systemic complications occurred, including pneumonia, cardiovascular disorder, urinary tract infection, hypoproteinemia, deep vein thrombosis and pressure sore. No significant difference was found between the two groups in systemic complications. Two cutouts occurred in the PFNA group, but none occurred in the PFNA-II group. Several patients reported thigh pain during the follow-up period: 8 patients in the PFNA-II group and 18 in the PFNA group (P < 0.05). In the
Table 4 Outcome of follow-up according to Harris and visual analogue scale.
HHS VAS Mortality (%)
PFNA-II
PFNA
P-value
86.19 ± 6.53 (58–93) 0.87 ± 0.85 (0–3) 7
85.27 ± 5.47 (66–93) 0.97 ± 0.87 (0–3) 6
0.326 0.448 0.557
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation; HHS: Harris Hip Score; VAS: visual analogue scale.
PFNA-II group, fewer local complications were observed (P < 0.05) (Table 3). The mean HHS was 86.19 in the PFNA-II group and 85.27 in the PFNA group, and the mean VAS was 0.87 in the former and 0.97 in the latter group. The mortality rate at one year was 7% in the PFNA-II group, compared with 6% in the PFNA group. No significant difference was found between the two groups in HHS, VAS and the one-year mortality rate (P > 0.05) (Table 4). 4. Discussion In the present study, we compared PFNA and PFNA-II for the treatment of unstable intertrochanteric fractures in elderly Chinese patients. Our results suggested that the rate of complications using PFNA-II was lower than PFNA for the treatment of unstable intertrochanteric fractures in elderly Chinese patients, and the operation time was shorter. A weakness of this study is that the operations were performed by different surgeons, however, a single observer collected data and the surgical procedure was the same. The study design was a
Table 2 Operative records of patients.
Operation time (min) Blood loss (mL) Blood transfusion (U) Fluoroscopy time (s) Postoperation drainage (mL) Hospitalization duration (d) Fracture reduction Good Acceptable Poor The position of implant Optimal Suboptimal Tip apex distance (mm)
PFNA-II
PFNA
P-value
66.25 ± 13.15 (43–128) 131.86 ± 69.16 (30–300) 2.37 ± 0.88 (1–4) 87.36 ± 21.80 (25–200) 68.56 ± 26.34 (20–200) 10.81 ± 3.28 (6–16)
79.50 ± 21.12 (49–142) 162.14 ± 66.18 (100–350) 2.75 ± 0.87 (1–4) 87.64 ± 13.41 (60–121) 71.34 ± 21.61 (30–150) 10.30 ± 2.56 (6–15)
0 0.004 0.221 0.921 0.456 0.234 0.775
93 20 5
58 10 2
102 16 19.25 ± 4.71 (9–36)
53 17 19.04 ± 4.70 (10–31)
0.075
PFNA-II: Asia proximal femoral nail antirotation; PFNA: proximal femoral nail antirotation.
0.766
146
J. Li et al. / Orthopaedics & Traumatology: Surgery & Research 101 (2015) 143–146
retrospective design; the two groups were comparable according to major variables (gender, age, BMI, side of fracture, type of fracture, ASA score and follow-up time). However, a randomized, prospective study is needed in the future to further confirm the current findings. Intertrochanteric fractures is one among the most common injuries in the elderly population, and patients’ quality of life is affected significantly [16–19]. The goal of treating these osteoporotic fractures is the same as for other hip fractures: to decrease pain and to restore the patient’s walking ability to the pre-injury level [20,21]. The treatment of unstable intertrochanteric fractures remains challenging to orthopedic surgeons, because of old age and poor bone quality [22–24]. Moreover, the ideal treatment for unstable intertrochanteric fractures in elderly patients remains controversial [25–27]. The proximal femoral nailing (PFN) has been widely used in the unstable intertrochanteric fractures [28]. The AO/ASIF group further modified PFN to the PFNA to ameliorate the angular and rotational stability with one single element. It is an intramedullary device with a helical blade rather than a screw for better purchase in the femoral head and was tested in a clinical study [10]. Because of the height in Asian population on average is less than that of Americans or Europeans, the femoral neck diameter and proximal femoral length are relatively shorter [29]. The standard proximal femoral nail antirotation nail has a mediolateral angle of 6◦ and a proximal diameter of 17 mm. To insert the nail, a much larger femoral canal needs to be prepared to accommodate the nail of the given diameter [30]. This means that a mass of cortical bone has to be reamed, thus weakening the osteoporotic bone in most patients. The study shows that the necessary over reaming of the shaft weakens the entire shaft, and that reaming of the medulla can result in increased blood loss [31,32]. Moreover, this geometric mismatch between the proximal end of the nail and proximal femur is the most probable cause of the intraoperative complications of jamming and fracturing of the lateral cortex. The PFNA-II was designed to avoid these problems, which was designed to have a mediolateral angle of 5◦ and a proximal diameter of 16.5 mm. The modified nail has a considerably better anatomic fit. This effectively decreases the hoop stress inside the femoral shaft and may have led to a significant decrease in intraoperative and postoperative diaphyseal fractures [33]. Unstable intertrochanteric fractures were treated successfully with the PFNA or PFNA-II in elderly Chinese patients. However, PFNA-II is superior to PFNA in terms of surgical time, intraoperative blood loss, and postoperative complications in elderly Chinese patients. Further study is needed to confirm these early results. Disclosure of interest The authors declare that they have no conflicts of interest concerning this article. References [1] Stevens JA, Olson S. Reducing falls and resulting hip fractures among older women. MMWR Recomm Rep 2000;49:3–12. [2] Felson DT, Anderson JJ, Hannan MT, Milton RC, Wilson PW, Kiel DP. Impaired vision and hip fracture. The Framingham Study. J Am Geriatr Soc 1989;37:495–500. [3] Tong P, Jin H, Shen Y, et al. Research of You Gui Yin and MSCs interventional therapy on early avascular necrosis of the femoral head. Zhong guo Xiu Fu Chong Jian Wai Ke Za Zhi 2009;23:456–62. [4] Pu JS, Liu L, Wang GL, Fang Y, Yang TF. Results of the proximal femoral nail anti-rotation (PFNA) in elderly Chinese patients. Int Orthop 2009;33:1441–4.
[5] Zhang S, Zhang K, Jia Y, Yu B, Feng W. Intertan nail versus proximal femoral nail antirotation-Asia in the treatment of unstable trochanteric fractures. Orthopedics 2013;36:e288–94. [6] Lv C, Fang Y, Liu L, et al. The new proximal femoral nail antirotation-Asia: early results. Orthopedics 2011;34:18–23. [7] Yang YH, Wang YR, Jiang SD, Jiang LS. Proximal femoral nail antirotation and third-generation Gamma nail: which is a better device for the treatment of intertrochanteric fractures? Singapore Med J 2013;54:446–50. [8] Shen L, Zhang Y, Shen Y, Cui Z. Antirotation proximal femoral nail versus dynamic hip screw for intertrochanteric fractures: a meta-analysis of randomized controlled studies. Orthop Traumatol Surg Res 2013;99:377–83. [9] Mereddy P, Kamath S, Ramakrishnan M, Malik H, Donnachie N. The AO/ASIF proximal femoral nail antirotation (PFNA): a new design for the treatment of unstable proximal femoral fractures. Injury 2009;40:428–32. [10] Simmermacher RK, Ljungqvist J, Bail H, et al. The new proximal femoral nail antirotation (PFNA) in daily practice: results of a multicentre clinical study. Injury 2008;39:932–9. [11] Garg B, Marimuthu K, Kumar V, Malhotra R, Kotwal PP. Outcome of short proximal femoral nail antirotation and dynamic hip screw for fixation of unstable trochanteric fractures. A randomised prospective comparative trial. Hip Int 2011;21:531–6. [12] Xu YZ, Geng DC, Mao HQ, Zhu XS, Yang HL. A comparison of the proximal femoral nail antirotation device and dynamic hip screw in the treatment of unstable pertrochanteric fracture. J Int Med Res 2010;38:1266–75. [13] Yaozeng X, Dechun G, Huilin Y, Guangming Z, Xianbin W. Comparative study of trochanteric fracture treated with the proximal femoral nail anti-rotation and the third generation of gamma nail. Injury 2010;41:1234–8. [14] ASA Physical Status Classification System. American Society of Anesthesiologists, 1963, http://www.asahq.org/clinical/physicalstatus.htm [15] Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am 1969;51:737–55. [16] Babst R, Renner N, Biedermann M, et al. Clinical results using the trochanter stabilizing plate (TSP): the modular extension of the dynamic hip screw (DHS) for internal fixation of selected unstable intertrochanteric fractures. J Orthop Trauma 1998;12:392–9. [17] Kenzora JE, McCarthy RE, Lowell JD, Sledge CB. Hip fracture mortality. Relation to age, treatment, preoperative illness, time of surgery, and complications. Clin Orthop Relat Res 1984;86:45–56. [18] Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ. Mortality following hip fracture: trends and geographical variations over the last 40 years. Injury 2008;39:1157–63. [19] Richmond J, Aharonoff GB, Zuckerman JD, Koval KJ. Mortality risk after hip fracture. J Orthop Trauma 2003;17:S2–5. [20] Bosch U, Schreiber T, Krettek C. Reduction and fixation of displaced intracapsular fractures of the proximal femur. Clin Orthop Relat Res 2002;399:59–71. [21] Lorich DG, Geller DS, Nielson JH. Osteoporotic pertrochanteric hip fractures: management and current controversies. Instr Course Lect 2004;53:441–54. [22] Zhang B, Chiu KY, Wang M. Hip arthroplasty for failed internal fixation of intertrochanteric fractures. J Arthroplasty 2004;19:329–33. [23] Hsu CJ, Chou WY, Chiou CP, Chang WN, Wong CY. Hemi-arthroplasty with supplemental fixation of greater trochanter to treat failed hip screws of femoral intertrochanteric fracture. Arch Orthop Trauma Surg 2008;128:841–5. [24] Haidukewych GJ, Berry DJ. Hip arthroplasty for salvage of failed treatment of intertrochanteric hip fractures. J Bone Joint Surg Am 2003;85:899–904. [25] Little NJ, Verma V, Fernando C, Elliott DS, Khaleel A. A retrospective trial comparing the Holland nail with the dynamic hip screw in the treatment of intertrochanteric fractures of the hip. J Bone Joint Surg Br 2008;90:1073–8. [26] Anglen JO, Weinstein JN. Nail or plate fixation of intertrochanteric hip fractures: changing pattern of practice. A review of the American Board of Orthopaedic Surgery Database. J Bone Joint Surg Am 2008;90:700–7. [27] Aros B, Tosteson AN, Gottlieb DJ, Koval KJ. Is a sliding hip screw or im nail the preferred implant for intertrochanteric fracture fixation? Clin Orthop Relat Res 2008;466:2827–32. [28] Windolf J, Hollander DA, Hakimi M, Linhart W. Proximal femoral nail (PFN): pitfalls and complications in the use of the proximal femoral nail. Langenbecks Arch Surg 2005;390:59–65. [29] Leung KS, Procter P, Robioneck B, Behrens K. Geometric mismatch of the Gamma nail to the Chinese femur. Clin Orthop Relat Res 1996;323:42–8. [30] Menezes DF, Gamulin A, Noesberger B. Is the proximal femoral nail a suitable implant for treatment of all trochanteric fractures? Clin Orthop Relat Res 2005;439:221–7. [31] Friedl W, Colombo-Benkmann M, Dockter S, Machens HG, Mieck U. Gamma nail osteosynthesis of per- and subtrochanteric femoral fractures. 4 years experiences and their consequences for further implant development. Chirurg 1994;65:953–63. [32] Pratt DJ, Papagiannopoulos G, Rees PH, Quinnell R. The effects of medullary reaming on the torsional strength of the femur. Injury 1987;18:177–9. [33] Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury 1992;23:291–2.