Abstract
Objectives
This was a prospective, randomized controlled trial to test functional outcomes between a single lag screw and helical blade nails in the treatment of intertrochanteric fractures.
Methods
72 patients with intertrochanteric fractures between March 2019 to November 2020 were randomized into two groups and treated with a lag screw or a helical blade nail. Intraoperative parameters such as operative time, blood loss, and radiation exposure were calculated. Postoperatively, tip apex distance, neck length, neck-shaft angle, lateral impingement of implant, union rate, and the functional outcomes were measured at the end of 6 month follow-up period.
Results
There was a significant decrease in tip apex distance (p = 0.03) and neck length(p-0.04) with significant lateral impingement of the implant (p = 0.04) in the helical blade group compared to the lag screw group. The functional outcome calculated using the modified Harris Hip score & Parker and Palmer mobility score, at the end of 6 months, had no significant difference between the two groups.
Conclusion
Both lag screw and helical blade devices can be used to successfully treat these fractures, although there is greater medial migration in the helical blade as compared to the lag screw.
Keywords: Intertrochanteric fracture, Lag screw vs helical blade, PFNA, Elderly
Introduction
Intertrochanteric fractures are a common orthopaedic problem encountered in daily practice [1, 2]. Prompt surgery with stable internal fixation is considered the best mode of treatment for these patients especially in the elderly [3, 4]. Delayed surgery is associated with increased mortality and morbidity, increased risk of bedsores, and respiratory tract infections [5–8]. Sliding hip screws and cephalo-medullary nailing are the most commonly used implants for the treatment of trochanteric fractures worldwide [9]. Among these, DHS is the preferred mode of treatment for stable trochanteric fracture whereas Intramedullary nailing is now the preferred mode of treatment for unstable intertrochanteric fractures [10].
Few studies have compared the outcomes of the helical blade and lag screw intramedullary nail devices. Sommers et al. concluded that the incidence of cut-out, varus migration, and femoral head rotation was significantly low in the case of helical blade Proximal Femur Nail (PFN) in comparison to lag screw PFN [11]. Stern et al. [12], on the other hand, found a significantly more cut-out rate with the use of a helical blade in comparison to the use of a lag screw design. Thus, there is still a lack of clarity regarding the choice of implant between the lag screw and helical blade devices.
This study was conducted to analyse any difference in the outcomes between the lag screw and helical blade intramedullary devices. We hypothesized that there was no difference in radiological and clinical outcomes between helical blade devices and lag screw devices in the treatment of intertrochanteric fractures.
Materials and Methods
This was a prospective, randomized controlled trial where 72 patients over the age of 50 years with intertrochanteric fracture (31 A1–A3) due to falls from standing height were enrolled. The study was commenced after getting approval from the institute ethics committee and after getting the study registered with the clinical trial registry-India (CTRI- CTRI/2019/02/017733). The inclusion criteria included patients presenting to our institute with less than 3 weeks old intertrochanteric fracture following a low-energy trauma between March 2019 to November 2020, and who were over 50 years of age. Patients having fractures following high-velocity trauma or polytrauma, who were unable to walk before surgery, who had signs of pathological fracture, and who refused to give consent were excluded from the study (Fig. 1).
Fig. 1.
CONSORT flow diagram
On admission, the A.O. alphanumeric classification was used to classify the fractures after obtaining radiographs—pelvis with both hips in AP view and non-contrast CT scan of pelvis with both hips. Pre-operative mobility was confirmed from history and documented using the Parker and Palmer mobility score. X-ray and CT-based neck-shaft angle and neck length of the contralateral side were measured (Fig. 2). The neck-shaft angle and femoral neck length were measured as suggested in the study by Michelotti et al. [13]. Computer-generated randomization was used to randomize these patients into a Lag screw group (group I) and a Helical blade group (group II) while, concealment of randomization was done by sequentially numbered, sealed, opaque envelopes. The envelopes were opened before surgery by the operating surgeon. Nail with the option for both screw and blade were used to avoid any variables other than the screw and blade. All the fractures were treated on the operating fracture table in a supine position under general anesthesia or regional anesthesia with the use of C-arm fluoroscopy. The choice of implants was decided based on the selection of sequentially numbered, sealed, opaque envelopes, which had the implant's name written on them. The fractures were reduced by closed reduction with the possible aid of bone hooks. In the AP view, the nail insertion point was aimed at the tip or slightly lateral to the tip of the greater trochanter, and on the lateral view the entry point for the nail was aimed to center in the greater trochanter and in line with the medullary canal. We aimed to fix both the implants in the central femoral neck on the lateral view and in the central/inferior femoral neck on the anteroposterior view, with the tip apex distance (TAD) of 10–25 mm. The nails were inserted without reaming the medullary canal. Blade was introduced into the central of the femoral head without drilling, while a lag screw was inserted after drilling under fluoroscopy guidance. All nails were locked distally, and no drains were applied. All surgeries were performed in the same institution, using the same standard surgical technique, using synthesis trochanteric fixation nails, and were done by the same group of experienced surgeons. Blood loss, operative time, number of exposures of C arm, and amount of radiation (in mGY) were recorded at the end of surgery. On the first post-operative day, plain AP (Antero-Posterior) and lateral radiographs were obtained. All patients underwent a CT scan within 1 week of surgery and at 6 months postoperatively as per study protocol. In coronal CT 2D reconstruction as well as plain radiographs, neck length; neck-shaft angle; tip apex distance [14]; and screw position were assessed and were compared with results at the end of 6 months. The screw position was checked by two means as shown in Fig. 2. The Cleveland index was used to calculate the position of the lag screw and helical blades. A centre-centre or centre-inferior placement of the lag screw or helical blade was considered optimal. Cut-out was defined as the protrusion of the implant outside of the femoral head into the hip joint on any radiographic view.
Fig. 2.
Measurements on preoperative and postoperative imaging, on post-operative image CD—neck length; CDI—neck shaft angle; EF—lateral distance; GH—implant outside femur and TAD were calculated using baumgaertners formula (TAD− AB x (true nail diameter/calculated nail diameter(ab)) + xlat x (true nail diameter/calculated nail diameter)
Patients were followed up at 2 weeks, 6 weeks, 3 months, and 6 months and were assessed clinically and radiologically (Figs. 3, 4). Functional assessment was done after 6 months as per modified Harris Hip Score, Timed up and go test and Parker and Palmer mobility score.
Fig. 3.
76 years old female with AO 31A1.3 fracture. a Pre-operative anteroposterior view, b anteroposterior view at 6 months follow-up, c lateral view at 6 months follow-up. b, c Shows union at 6 months
Fig. 4.
63 years old female with AO31A2.2 type fracture. a Preoperative anteroposterior view, b anteroposterior view at 6 months follow-up, c lateral view at 6 months follow-up. b, c Showing union at 6 months
Statistical Analysis
Considering no difference in the effect of treatment modality with SD of Harris Hip Score at the primary endpoint of study as 6.5 [15], the non-inferiority margin of (-4), power of 80%, alpha of 5% (1 sided) and 20% lost to follow up and attrition, it was decided to recruit 36 patients in each group. Continuous variables were compared by independent T-test/ Wilcoxon’s signed-rank test. Categorical data were compared by Chi-square test/ Fisher exact test. The data was analyzed using SPSS Ver 25 (IBM Corp, NY). A p value of < 0.05 was considered as significant.
Results
The mean age group of the patients was 72 years (51–96 years) with 61% females. The demographics were comparable in both groups (Table 1). Group I required longer operative time, had more blood loss, with higher radiation exposure compared to group II, but the differences between the two groups were not statistically significant (Table 1).
Table 1.
Baseline demographics and intra-operative parameters
| Group I (n = 36) | Group II (n = 36) | p value | |
|---|---|---|---|
| Age(years)a | 72.36 ± 10.24 | 71.55 ± 9.93 | 0.73 |
| Sex (male/female) | 13/23 | 15/21 | 0.62 |
| AO classification | 0.48 | ||
| A1 | 10 | 13 | |
| A2 | 24 | 22 | |
| A3 | 2 | 1 | |
| Operative Time(in minutes)a | 30.97 ± 21.64 | 29.08 ± 16.46 | 0.94 |
| Blood Loss(in ml)a | 60.27 ± 44.43 | 58.05 ± 40.62 | 0.97 |
| Radiation Exposure(mGY)a | 10.16 ± 7.24 | 9.95 ± 6.41 | 0.94 |
aValue in mean ± standard deviation
Of the 36 patients allocated to group I, 4 patients died and 2 were lost to follow-up. Of the 36 allocated to group II, 4 patients died and 1 was lost to follow-up. 88% of the screw and 83% of the blade were placed in Cleveland zone 5 and 8, and the difference was not significant. The mean postoperative neck-shaft angle was 131 ± 4.5 degrees on the X-ray and 128.9 ± 3.6 degrees on the CT scan for the screw group, and 130 ± 4.46 degrees on the X-ray and 128.8 ± 5.9 degrees on the CT scan for the blade group. We also measured the neck-shaft angle at follow-up and compared it with the previous measurements. We found that there was a greater change in neck-shaft angle in the screw group in comparison to the blade group, both on CT scans and X-rays (2.95 ± 3.36 degree in the screw group, and 1.96 ± 4.72 degree in the blade group), although the difference was statistically not significant. The Tip apex distance was more for the screw group compared to the blade group postoperatively, and there was a significant decrease in the tip apex distance at 6 months in the blade group (p-0.032) (Table 2). There was a significant decrease in neck length (p-0.041) in the blade group compared to the screw group at the end of 6 months of follow-up (Table 3). There was also significant lateral impingement in the blade group noted on X-ray imaging’s (p-0.039), at the final follow-up (Table 4). There was one case of medial migration of the helical blade in group II for which a repeat surgery was needed. There was one case of non-union at 6 months in group II for which the patient refused any further surgical intervention. There was one case of local infection which was managed with oral antibiotics.
Table 2.
Tip apex distance
| X-ray | p value | CT scan | p value | |||
|---|---|---|---|---|---|---|
| Group I | Group II | Group I | Group II | |||
| Tip apex distance post-surgery (mm)a | 19.53 ± 4.87 | 21.64 ± 5.35 | 0.08 | 21.00 ± 5.02 | 23.23 ± 6.26 | 0.09 |
| Tip apex distance at 6 months (mm)a | 20.30 ± 5.61 | 20.54 ± 5.36 | 0.86 | 21.23 ± 5.33 | 20.15 ± 5.04 | 0.36 |
| p value | 0.55 | 0.40 | 0.85 | 0.032b | ||
aThe value represented as mean ± standard deviation
bSignificant values
Table 3.
Neck length
| X-ray | p value | CT scan | p value | |||
|---|---|---|---|---|---|---|
| Group I | Group II | Group I | Group II | |||
| Neck length post-surgery (mm)a | 52.30 ± 8.10 | 50.96 ± 6.16 | 0.43 | 49.60 ± 5.71 | 50.12 ± 5.88 | 0.70 |
| Neck length at 6 months (mm)a | 50.88 ± 7.88 | 48.08 ± 5.7 | 0.11 | 48.11 ± 5.65 | 46.87 ± 6.28 | 0.42 |
| p value | 0.47 | 0.052 | 0.78 | 0.041b | ||
aThe value represented as mean ± standard deviation
bSignificant values
Table 4.
Lateral distance of implant
| X-ray | p value | CT scan | p value | |||
|---|---|---|---|---|---|---|
| Group I | Group II | Group I | Group II | |||
| Lateral distance post-surgery (mm)a | 20.48 ± 5.58 | 17.75 ± 6.05 | 0.051 | 19.07 ± 5.22 | 17.90 ± 6.19 | 0.39 |
| Lateral distance 6 months (mm)a | 21.14 ± 6.10 | 21.13 ± 7.45 | 0.99 | 19.82 ± 4.82 | 18.23 ± 7.55 | 0.33 |
| p value | 0.64 | 0.039b | 0.54 | 0.84 | ||
aThe value presented as mean ± standard deviation
bSignificant values
The functional outcome between the two groups compared using the modified Harris Hip score (p-0.86), Parker and Palmer mobility score (p-0.59), The Timed Up and Go test (p-0.87), at the end of 6 months of follow-up, was found to be statistically non-significant (Table 5).
Table 5.
Functional outcome at 6 months
| Group I | Group II | p value | |
|---|---|---|---|
| Modified Harris hip scorea | 71.21 ± 7.65 | 71.9 ± 7.70 | 0.72 |
| Parker and Palmer scorea | 7.82 ± 1.18 | 7.87 ± 0.92 | 0.85 |
| Timed up and go test (in seconds)a | 23.74 ± 9.76 | 22.24 ± 7.04 | 0.49 |
aThe value presented as mean ± standard deviation
Discussion
Intertrochanteric fractures have been a cause of huge burden to the healthcare sector all over the world [16]. The falling death rates have led to an increase in the geriatric population who in turn are more prone to hip fractures especially an intertrochanteric fracture, thereby leading to an increasing number of patients with intertrochanteric fractures [3]. Cephalomedullary nails are more commonly used now compared to sliding hip screws for intertrochanteric fractures [17]. Amongst the various reasons for the failure of a cephalomedullary nail, cut out of the lag screw is one of the most common reasons for fixation failure [18]. Subsequently, helical blade PFN’s were introduced to decrease the rate of fixation failure.
The use of helical blade devices was publicized based on biomechanical studies which had shown that there was denser trabecular bone formation around the helical blade implant, which might decrease the risk of the cut-out [19]. In Stern et al.’s [20] prospective randomized study, they concluded that either of the two, whether a screw or a blade, can be used to stabilize low-energy trochanteric femur fractures. Huang et al. [21] conducted a meta-analysis comparing all blade and screw designs. They concluded that the operative time and the radiation exposure were significantly higher in the screw group compared to the blade group. The functional outcome was comparable between the two groups. In another study by D’Arrigo et al. [22], they compared patients treated with either a lag screw or a helical blade group for one year. They recommended PFNA in patients who had osteoporotic bones, and gamma nails (lag screw) in those patients who had severely displaced fractures and better bone quality although they found there was no statistical difference in the functional outcome between the two groups using the Harris hip score. When comparing the cut-out rates between the helical blade and lag-screw group in intertrochanteric fractures, Van Leur et al. and Mitchell et al. found no significant difference between the two groups [23, 24]. Similarly, Yang et al. [25] concluded that there was no significant difference in operative time, blood loss, radiation exposure, implant position, postoperative complication, and functional outcome between the two groups. Shin et al. [26], compared the functional outcome between the lag screw and helical blade group of 353 patients at 6 months and found that there was no significant statistical difference between the two groups.
Our study was a prospective, randomized controlled trial that compared the lag screw and helical blade devices in intertrochanteric fractures. Most of the present guidelines advocate that the subchondral placement of the spiral blade should be avoided as it has more sliding potential and the propensity to have a medial head penetration as compared to the lag screw nails [27]. The helical blade group, in our study, had significantly more neck collapse compared to the screw group. We found that there was a significant decrease in tip apex distance in the helical blade group, at 6 months of follow-up, compared to the lag screw group. There was also significant lateral impingement of the helical blade compared to the lag screw, although the difference was significant only on X-ray imaging. The inference was that there was more collapse at the fracture site along with greater medial migration in the blade group without having any significant difference in the functional outcomes or failure rates, at the end of the follow-up period between the two groups.
Most of the studies have found higher blood loss, operative time, radiation exposure in the screw group compared to the blade group. The reason for the less time in blade insertion may be the fact that it needs to be hammered in while the lag screws are rotated in the femoral head which takes slightly more time than the blade insertion and also has issues of rotating proximal fragment which needs to be taken care of [22, 26]. We found that the blood loss, operative time, and radiation exposure were numerically higher in the screw group compared to the blade group, although the difference was non-significant in our study. The functional outcome, at the end of the follow-up, in our study was comparable in both groups, which was the inference of most studies [20, 22, 23, 26].
There are a few limitations to our study. Ours was a single-center study with a short to medium follow-up of only 6 months. Even though few variations in the parameters were observed between the two groups during the follow-up period, but most of these were found to be statistically non-significant in our study. The strength of this study is that this was a randomized controlled trial where we also used CT scans, pre and post-operatively to measure the radiological parameters.
Conclusion
Inspite of a greater potential of neck collapse, and medial migration in the helical blade group, there was no significant difference in the functional outcomes or failure rates between the Helical blade group and the Lag screw group at the end of 6 months of follow-up. Both implants were found to be equally effective in the treatment of intertrochanteric fractures. We would suggest having a higher-than-normal tip apex distance and using appropriately sized nails owing to greater medial migration, with neck collapse, and a propensity for lateral impingement in the blade group.
Funding
None.
Data availability
Datasets generated or analysed during the current study are available with the computerised data in the Institute of research.
Declarations
Conflict of Interest
The authors have no conflict of interest to declare.
Ethical Clearance
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of AIIMS New Delhi (IECPG-628/19.12.2018, RT-27/23.01.2019). CTRI – The trial was registered on 20th February 2019, and the trial number is CTRI/2019/02/017733.
Informed Consent
For this type of study informed consent is not required.
Footnotes
Publisher's Note
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Datasets generated or analysed during the current study are available with the computerised data in the Institute of research.