Injury 53 (2022) 1184–1189

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Injury
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Cement distribution and initial fixability of trochanteric fixation nail

advanced (TFNA) helical blades
Sadaki Mitsuzawa a,∗, Shuichi Matsuda b
a
Department of Orthopaedic Trauma, Senshu Trauma and Critical Care Center, Rinku General Medical Center, Osaka, Japan
b
Department of Orthopaedic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Introduction: Early fixation and rehabilitation is the gold standard treatment for intertrochanteric fe-
Accepted 27 October 2021 mur fractures. To avoid postoperative complications such as cut-out or cut-through, cement augmenta-
tion with perforated helical blades has been developed. The purpose of this study was to evaluate the
Keywords: distribution of injected cement at the head–neck portion of proximal femur using computed tomography
Proximal femur fracture (CT) and to examine its initial fixability and clinical outcomes.
Trochanteric fixation nail advanced (TFNA) Patients and methods: Elderly patients who had intertrochanteric fractures were treated with a helical
Cement augmentation blade only (BO group) or with a helical blade and cement augmentation (CA group). After fracture reduc-
Cement distribution tion, trochanteric fixation nail advanced (TFNA) helical blades were inserted, aiming at the center/center
Initial fixability
position with 20 mm of tip-apex distance. In the CA group, 4.2 mL of cement was injected under an
Computed tomography (CT)
image intensifier (1.8 mL of cement was directed cranially and 0.8 mL each was directed to the caudally,
anteriorly, and posteriorly). Patient demographics, radiographic parameters with CT, and post-operative
clinical outcome were examined.
Results: Each group included nine patients with similar demographics. Maximum penetration depth
(MPD) in the CA group was significantly greater than those in the BO group for all four directions
(p < 0.01). In the CA group, the anterior MPD was significantly greater than the posterior (p < 0.01)
and the cranial (p = 0.02) MPD. Surface area and volume in the CA group were two-times and three-
times larger than that in the BO group, respectively. Among radiographic parameters, Rotation angle in
the CA group was significantly smaller than that of the BO group (p = 0.03). For the Parker score, the
CA group showed less of a decrease than in the BO group (p < 0.01). Visual analog scale (VAS) for the
passive range of motion (ROM) and for full-load walking in the CA group was significantly lower than
those in the BO group (p < 0.01).
Conclusions: The initial fixability of the TFNA helical blade with cement augmentation demonstrated dou-
ble the surface area and triple the volume. This suppressed implant micro-motion, reduced postoperative
pain, and accelerated rehabilitation in the acute phase.
© 2021 The Authors. Published by Elsevier Ltd.
This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/)

Introduction patients despite continuous improvements to the implant design

Intertrochanteric femur fractures are one of the most frequent
geriatric traumas, leading to a high rate of mortality and morbidity
in elderly people. Early fixation and rehabilitation is the gold stan-
dard treatment to prevent complications that are associated with
being bedridden for a long time. Although surgical fixation using a
cephalomedullary nail is the most popular method, postoperative
complications such as cut-out or cut-through occurs in up to 8% of
∗
Corresponding author.
E-mail address: sadakimitsuzawa@gmail.com (S. Mitsuzawa).
[1]. Severe osteoporosis as well as inadequate fracture reduction
and suboptimal implant position are the risk factors for the above-
mentioned complications. To avoid the further revision operations,
total hip arthroplasty is the only valid salvage procedure in such
cases [2]. This procedure, however, exposes these patients to risks
during surgery and for postoperative care.
Since 2011, polymethylmethacrylate (PMMA) cement augmen-
tation with perforated helical blades for proximal femur fractures
has been developed and investigated in cadaveric and clinical stud-
ies [3–5]. Cement augmentation showed promising biomechani-
cal and clinical results especially in osteoporotic patients. Higher

https://doi.org/10.1016/j.injury.2021.10.028
0020-1383/© 2021 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
S. Mitsuzawa and S. Matsuda
mechanical stability of head elements was achieved by the bone
cement–implant interface regardless of the poor bone stock. Thus,
there have been no publications on the complication of implant
failure such as cut-out or cut-through [6–9]. Although the amount
and distribution of injected cement is important, no study, to the
best of our knowledge, has examined the detailed distribution of
cement using computed tomography (CT).
This study was designed to evaluate the efficacy of the cement
augmentation system of the new-generation Trochanteric Femoral
Nail Advanced (TFNA) (DePuy Synthes) perforated helical blade,
which became available in Japan in November 2020. The purpose
of this prospective cohort study was to evaluate the distribution of
injected cement at the head–neck portion of proximal femur using
CT and to examine its initial fixability along with clinical outcomes.
Materials and methods
The study protocol and research were performed in accordance
with the Ethics Committee at our institution. This pilot study was
designed as a single-center prospective cohort study that com-
pared elderly patients who are undergoing TFNA with or with-
out cement augmentation. From 15 September 2020 to 31 Octo-
ber 2020, elderly patients who had intertrochanteric fractures were
treated using a helical blade only (BO group). From 1 November
2020 to 31 December 2020, elderly patients with intertrochanteric
fractures were treated using a helical blade and cement augmen-
tation (CA group). Patients 60 years and older who had a closed
intertrochanteric fracture (AO Foundation/Orthopaedic Trauma As-
sociation (AO/OTA) classification 31A1–A3), with a follow-up pe-
riod of at least three months were included in this study. The ex-
clusion criteria were as follows: (1) occult fracture detected only
by magnetic resonance imaging; (2) pathological fracture; (3) pres-
ence of pre-existing implants; or (4) multiple trauma or additional
fracture, which would affect the patient’s postoperative rehabilita-
tion.
Surgical technique and postoperative protocol
All operations were performed by the first author. The frac-
ture was reduced on a traction table. In cases where the an-
teromedial cortex of the proximal fragment was wedged into the
medullary cavity of the distal fragment, an additional reduction
technique was used to achieve the optimal position. After reduc-
tion of the fracture, a TFNA (DePuy Synthes, West Chester, PA, USA)
was inserted according to the manufacturer’s instructions. We in-
serted the helical blade, aiming for the center/center position with
20 mm of the tip–apex distance (TAD). The set screw was loos-
ened one-quarter turn to allow postoperative telescoping and frac-
ture compression. Intraoperative compression using a device was
not performed in any cases. All patients from November 2020 were
treated with a helical blade and cement augmentation. In the CA
group, 4.2 mL of PMMA cement (Traumacem V+ cement, DePuy
Synthes) was injected circumferentially using an image intensifier
to monitor anteroposterior (AP) and lateral views. By rotating the
side-opening cannula, 1.8 mL of cement was directed to the cranial
and 0.8 mL each was directed to the other three directions (caudal,
anterior, and posterior). The postoperative protocol was identical in
both groups; all patients were mobilized under physiotherapeutic
supervision with full weight bearing as tolerated starting on the
day after surgery.
Data collection
Patient demographic data included the following: age, gender,
body mass index (BMI), diabetes, tobacco use, Charlson comor-
bidity index, American Society of Anaesthesiologists (ASA) status,
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Injury 53 (2022) 1184–1189
dual-energy X-ray absorptiometry (DEXA) at the trochanter (bone
marrow density; BMD), T score and young adult mean (YAM), lat-
erality, AO/OTA fracture classification, and pre-fracture ambulatory
level (Parker score) [10,11]. The following intraoperative informa-
tion was recorded: operative time, intraoperative blood loss, pres-
ence of intraoperative complications such as tachycardia, rapid de-
crease in blood pressure or oxygen saturation, and nail length.
Radiographic parameters
On the day after surgery, CT evaluation was performed with a
window level of 2700 HU and window width of 5800 HU. This
window level and width minimized the artifact of the metal and
cement structure through measuring the radiographic parameters
below. In the current study, coronal, sagittal, and axial planes were
defined as follows: coronal plane, where the helical blade and in-
serted nail were placed on the same plane; sagittal plane, which
was perpendicular to the coronal plane and parallel to the heli-
cal blade; and axial plane, which was perpendicular to the coro-
nal and sagittal plane. On the axial plane, which had 36 successive
1 mm slices starting at the tip of the helical blade (slice 1), the
helical blade was cut into round slices (Fig. 1A). We evaluated the
reduction quality on the basis of Yoo’s et al. criteria [12], as fol-
lows: “good” (medial calcar cortex of the proximal fragment was
positioned in a neutral or medial position compared to the distal
fragment in the coronal plane, and the anterior cortex of proxi-
mal fragment was positioned in a neutral or anterior position com-
pared to the distal fragment in the sagittal plane), “acceptable”
(the reduction met the criteria for a “good” reduction for either
view but not both), or “poor” (the reduction met neither criteria).
In the coronal plane, TAD (coronal), Parker ratio (coronal), blade
end (the amount of helical blade protrusion from the lateral edge
of the nail), and maximum penetration depth (MPD) (cranial and
caudal) were measured (Fig. 1B). In the sagittal plane, TAD (sagit-
tal), Parker ratio (sagittal), and MPD (anterior and posterior) were
measured, based on previous studies (Fig. 1C) [13,14]. In the axial
plane, the rotation angle was measured, which is defined as the
angle between the nail–blade line and blade–medial calcar line on
axial slice 36, using the modified method of Yamazaki et al. [15].
On each axial plane through slices 1–36, the perimeter and area
were calculated using ImageJ software (National Institute of Health,
Bethesda, MD, USA) (Fig. 1D). The sum of perimeters and areas (36
slices) was defined as the surface area and volume of the head ele-
ment, respectively. On 14 days postoperatively, a CT scan was simi-
larly performed, and the difference value in the TAD (coronal), TAD
(sagittal), blade end, and rotation angle were calculated as delta
().
Clinical outcome measurement
At 14 days postoperatively, the Parker score, visual analog scale
(VAS) for the passive range of motion (ROM) and full-load walking
were evaluated. The difference value in the Parker score was cal-
culated as delta (). Within three months after surgery, postoper-
ative complication such as cut-out or cut-through were monitored.
Statistical analysis
Data were presented as the mean ± standard deviation (SD)
and analyzed using JMP Pro 14.0 (SAS Institute, Cary, NC, USA).
The Student’s t-test was used to compare the demographic data,
radiographic parameters, and clinical outcomes of the BO and CA
groups. Fisher’s exact test was performed to analyze categorical
data. Values of p < 0.05 were considered to be statistically sig-
nificant.
S. Mitsuzawa and S. Matsuda Injury 53 (2022) 1184–1189

Fig. 1. Radiographic parameters using CT (A) Three dimensional (3D) image shows cement distribution around the helical blade. The head element was cut into round slices
in the axial plane, which shows 36 successive 1 mm slices starting at the tip of the helical blade (slice 1). (B) Coronal plane: where the helical blade and inserted nail were
placed in the same plane. The maximum penetration depth (MPD) (cranial and caudal) was measured (red arrow). (C) Sagittal plane: perpendicular to the coronal plane
and parallel to the helical blade. The MPD (anterior and posterior) was measured (red arrow). (D) In the axial plane, the rotation angle (green arc) was measured on slice
36, which is defined as the angle between nail–blade line (yellow line) and the blade–medial calcar line (green line). The perimeters and areas (blue polygon shape) were
calculated in slices 1–36. The sum of the perimeters and areas (36 slices) was defined as the surface area and volume of the head element, respectively. (For interpretation
of the references to color in this figure legend, the reader is referred to the web version of this article).

Results group (10.1 ± 1.8 vs. 8.0 ± 2.1 mm; p = 0.04). The sagittal TAD in
the CA group tended to be larger than that in the BO group, but
During the study period, 18 patients underwent they were not significantly different. As mentioned in the Materi-
cephalomedullary nailing for intertrochanteric fractures. Each als and Methods, the amount of the injected cement in the cra-
group included nine patients. We assessed the patient demograph- nial direction was 1.8 mL, and that in the caudal, anterior, and
ics between two groups, and they were shown to be well balanced posterior directions was 0.8 mL each (Fig. 2A). In the BO group,
(Table 1). MPD in the cranial, caudal, anterior, and posterior directions was
Perioperative data is shown in Table 2. Although intraoperative 5.0 ± 0.0 mm, 5.2 ± 0.1 mm, 5.3 ± 0.0 mm, and 5.4 ± 0.1 mm,
data were not significantly different between two groups, intraop- respectively. In the CA group, MPD in the cranial, caudal, ante-
erative blood loss tended to be larger in the CA group than in the rior, and posterior directions was 10.3 ± 1.4 mm, 12.1 ± 1.3 mm,
BO group (99.1 ± 108.7 vs. 38.7 ± 40.4 mL; p = 0.17). The coronal 13.1 ± 2.9 mm, and 9.2 ± 1.6 mm, respectively, which was signif-
TAD in the CA group was significantly larger than that in the BO icantly greater than those in the BO group in all four directions

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S. Mitsuzawa and S. Matsuda Injury 53 (2022) 1184–1189

Table 1
Patients demographics.

BO group (n = 9) CA group (n = 9) p value

Mean age (years) 84.9 ± 6.5 81.0 ± 11.0 0.41

Male: Female 1: 8 3: 6 0.58
Body mass index (kg/m2 ) 20.8 ± 3.7 18.3 ± 2.6 0.15
Diabetes 2 4 0.62
Tobacco use 1 2 1.00
Charlson comorbidity index 2.7 ± 1.3 3.2 ± 1.7 0.57
ASA status 0.08
1 1 4
2 6 1
3 2 4
4 0 0
DEXA (Trochanter)
BMD (g/cm2 ) 0.368 ± 0.078 0.367 ± 0.096 0.97
T score −5.2 ± 1.5 −4.6 ± 1.5 0.44
YAM (%) 54.2 ± 9.0 52.8 ± 13.5 0.80
Right: Left 4: 5 5: 4
AO/OTA Fracture classification 0.69
31 A1 2 3
31 A2 6 4
31 A3 1 2
Pre-fracture Parker score 6.2 ± 1.3 5.8 ± 2.7 0.68

BO, blade only; CA, cement augmentation; ASA, American Society of Anaesthesiologists; DEXA, dual-energy X-ray ab-
sorptiometry; BMD, bone marrow density; YAM, young adult mean; AO/OTA, AO Foundation/Orthopaedic Trauma Asso-
ciation.

Table 2
Perioperative data.

BO group (n = 9) CA group (n = 9) p value

Operative time (min) 44.9 ± 24.3 52.8 ± 24.9 0.53

Intraoperative blood loss (mL) 38.7 ± 40.4 99.1 ± 108.7 0.17
Intraoperative complication None None
Nail length (Short: Long) 6: 3 6: 3
Reduction quality
Good 8 8
Acceptable 1 1
Poor 0 0
TAD, coronal (mm) 8.0 ± 2.1 10.1 ± 1.8 0.04
Parker ratio, coronal 0.50 ± 0.05 0.49 ± 0.03 0.66
TAD, sagittal (mm) 8.3 ± 2.0 10.1 ± 1.8 0.09
Parker ratio, sagittal 0.51 ± 0.04 0.50 ± 0.03 0.41
Blade end (mm) 15.2 ± 3.7 14.9 ± 2.2 0.87
Rotation angle (°) −4.9 ± 12.4 −10.4 ± 8.3 0.31

BO, blade only; CA, cement augmentation; TAD, tip–apex distance.

(p < 0.01). In the CA group, MPD in the anterior direction was sig- Table 3
Postoperative evaluation.
nificantly greater than that in the posterior (p < 0.01) and cranial
(p = 0.02) directions. MPD in the caudal direction was significantly BO group (n = 9) CA group (n = 9) p value
greater than that in the posterior direction (p = 0.02) (Fig. 2B). Sur- TAD, coronal (mm) 0.6 ± 0.4 0.4 ± 0.3 0.32
face area in the CA group was significantly larger than that in the TAD, sagittal (mm) 0.6 ± 0.3 0.4 ± 0.3 0.17
BO group (24.6 ± 1.9 mm2 vs. 11.0 ± 0.1 mm2 ; p < 0.01) (Fig. 2C). Blade end (mm) 2.6 ± 1.5 2.8 ± 1.8 0.79
Similarly, volume in the CA group was significantly larger than that Rotation angle (°) 1.3 ± 0.7 0.6 ± 0.2 0.03
Parker score −4.8 ± 1.2 −2.1 ± 1.0 < 0.01
in the BO group (6.2 ± 0.4 mm3 vs. 1.9 ± 0.1 mm3 ; p < 0.01)
VAS for the passive ROM 5.1 ± 1.8 2.2 ± 1.4 < 0.01
(Fig. 2D). VAS for full-load walking 6.3 ± 1.9 1.9 ± 1.4 < 0.01
The postoperative evaluation 2 weeks after surgery is shown in Cut-out / Cut-through 0 0
Table 3. For the TAD coronal, TAD sagittal, and Blade end, BO, blade only; CA, cement augmentation; TAD, tip–apex distance; VAS, visual ana-
there was no significant difference between the two groups. In- log scale; ROM, range of motion.
stead, Rotation angle in the CA group was significantly smaller
than that of the BO group (0.6 ± 0.2 vs. 1.3 ± 0.7; p = 0.03).
For the Parker score, the CA group exhibited a smaller de- Discussion
crease in the numeric value than the BO group (−2.1 ± 1.0 vs.
−4.8 ± 1.2; p < 0.01). VAS for the passive ROM in the CA group Implant micro-motion is one of the most important factors that
was significantly lower than that in the BO group (2.2 ± 1.4 is related to postoperative pain and functional recovery. The cur-
vs. 5.1 ± 1.8; p < 0.01). Similarly, VAS for full-load walking in rent prospective pilot study aimed to investigate the initial fixa-
the CA group was significantly lower than that in the BO group bility of TFNA with or without cement augmentation using a de-
(1.9 ± 1.4 vs. 6.3 ± 1.9; p < 0.01). No complications such as cut- tailed CT scan. Distribution of 4.2 mL of cement showed that the
out or cut-through were observed in any of the patients in either TFNA helical blade with cement augmentation had double the sur-
group. face area and triple the volume compared to that without ce-

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S. Mitsuzawa and S. Matsuda Injury 53 (2022) 1184–1189

Fig. 2. Cement distribution evaluated using CT. (A) The amount of the injected cement in four directions in the CA group (white quadrilateral): 1.8 mL in the cranial direction
and 0.8 mL each in the other three directions. (B) Maximum penetration depth (MPD) in the four directions. The CA group (white quadrilateral) demonstrated a greater MPD
in the four directions than the BO group (black quadrilateral) (p < 0.01). In the CA group, the anterior MPD (∗ 1) was significantly greater than that the posterior (p < 0.01)
and cranial (p = 0.02) MPDs. MPD in the caudal direction (∗ 2) was significantly greater than that in the posterior direction (p = 0.02). (C) The surface area of the head
element in the CA group was approximately two-times larger than that in the BO group.(D) The volume of the head element in the CA group was approximately three-times
larger than that in the BO group.

ment augmentation. Thus, the cement augmentation system de-
creases micro-motion of the helical blade inside the osteoporotic
femoral head and increases the mechanical stability immediately
after surgery, which reduced the pain and improved the early
phase of rehabilitation.
Cement is a familiar material to orthopaedic surgeons. Because
the cement penetration depth is determined depending on bone
porosity, injection pressure, and trabecular angle orientation, the
mechanical strength of the bone–cement interface is greater in
more osteoporotic bone [16]. This may explain why osteoporosis
is usually considered to be a good indication for the use of ce-
ment. The two main reasons for cement use are to improve the
implant stability or to decrease pain, which has been reported for
prosthetic replacement arthroplasty, balloon kyphoplasty, or frac-
tures in the proximal humerus, distal radius, distal femur, proximal
tibia, and calcaneous [17–23]. According to previous clinical stud-
ies, helical blade with cement augmentation suggested good clini-
cal outcomes and did not demonstrate any cut-out or cut-through
[6–9]. Although a relatively long-term follow-up time was set in
these studies, we set a 2-week follow-up time because the clini-
cal outcome within 14 days postoperatively was also shown to be
important [24]. To the best of our knowledge, a detailed CT eval-
uation for cement distribution has not been previously reported.
A more versatile and accurate assessment can be obtained using
1 mm slice CT scans than with a plain X-ray film evaluation.
The resistance force against pushing-in or rotation is essential
in the prevention of implant failure. TAD is an important factor of
the head element as it anchors the cancellous bone of the femoral
head. The technique guide for TFNA suggests a 10 mm distance
from the blade tip to the joint in the AP and lateral view, which
corresponds to a TAD of 20 mm. Flores et al. demonstrated that
a TAD of less than 20 mm was associated with increased implant
failure frequency [25]. Recent studies by Stern et al. and Ibrahim
et al. concluded that, although a larger TAD may lead to implant
failure, the optimal TAD during helical blade fixation remains un-
known [26,27]. We faithfully follow the above-mentioned tech-
nique guide for TFNA. Although the total TAD (TAD coronal plus
TAD sagittal) was around 20 mm and relatively small in the cur-
rent study, good reduction quality may reduce the incidence of
over-telescoping and subsequent cut-out/cut-through. Without ce-
ment augmentation, the interface between the implant and can-
cellous bone would not provide enough resistance force in osteo-
porosis patients. If the position of the helical blade deviates from
the center of the femoral head, even less resistance force would be
available [28]. The cement that penetrated into the bone formed
a rough-edged spindle shape completely around the helical blade,
which may provide sufficient resistance force for pushing-in or ro-
tation. In the coronal plane, injected cement was distributed to-
ward the cranial side where the load is applied and to the caudal
side along the upper edge of the primary compressive trabecula.
Cement was augmented correctly at Ward’s triangle where the de-
crease in BMD is greater with aging [29]. Because the cement that
is located cranially is effective and can endure a high load when
walking, we chose to inject 1.8 mL of PMMA cement in the cranial
direction and 0.8 mL in each of the other three directions. How-
ever, cranially injected cement flowed in an anterior direction and
tended to be located more anteriorly than posteriorly in the sagit-
tal plane. The anterior MPD is the longest of the four directions,
and more care should be taken in the lateral view than in the
AP view of the image intensifier to detect leakage during cement
injection. Blade end in the current study reflected the telescop-
ing of the head element, which was approximately 3 mm in both
groups. Rotation torque of the femoral head is generated when the
proximal and distal bony fragments are contacted at the end of the
telescope and when the load is applied to the femoral head. Aug-
mented cement provided sufficient stability even in osteoporotic

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S. Mitsuzawa and S. Matsuda
bone, which was reflected in the rotation angle and clinical results
2 weeks after surgery, as shown in Table 3. Rotation angle di-
rectly represents the resistance force to the rotation torque of the
femoral head, which should be the most important factor for an
implant stability.
There are several limitations in the present study. First, the cur-
rent study was a pilot study with a limited number of patients.
Further studies with a larger number of patients would be use-
ful. However, this is the first pilot study to investigate the ce-
ment distribution of TFNA using CT, which partially revealed the
mechanism that supports the benefits of cement augmentation.
Second, the follow-up period of this study was relatively short.
Our primary goal was to evaluate the cement distribution using
CT and to examine the initial fixability of cement augmentation,
which would be disturbed by callus formation at the fracture site.
A follow-up period of at least three months is appropriate be-
cause implant failure most often takes place within eight postoper-
ative weeks [9,25,26]. Third, osteonecrosis of the femoral head is a
possible complication, it was not monitored in this study because
it requires several years of follow-up. Although careful long-term
follow-up is highly recommended, this deviates from our primary
objective. A previous cadaveric study on the heat and pressure of
injected PMMA cement demonstrated the safety of this technique
[30,31], and the risk of osteonecrosis should be reduced by follow-
ing the manufacturer’s instructions (i.e., using 3–6 mL of cement).
Although this is a pilot study and is clearly a preliminary report,
the current study verified the superior initial stability of the TFNA
helical blade with cement augmentation. A doubling in the sur-
face area and a tripling in the volume minimized implant micro-
motion, reduced postoperative pain, and accelerated rehabilitation
in the acute phase. This cement technique may be effective for
osteoporotic patients, especially considering the increasing size of
the aging population in our society.
Declaration of Competing Interest
The authors have no conflicts of interest to disclose.
Acknowledgment
The study protocol and research were performed in accor-
dance with the Ethics Committee of Shin Kyoto Minami Hospital
(SHIN20-019). The authors would like to thank Dr. Fumihiko Hi-
roma, Dr. Morinobu Imadegawa, and all other medical staff at Shin
Kyoto Minami Hospital for their kind support.
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