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Injury xxx (xxxx) xxx
Contents lists available at ScienceDirect
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journal homepage: www.elsevier
Oper k
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PHIL
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https://doi.or
0
ative treatment of 2-part surgical nec
oximal humerus in the elderly: Cement
OS
TM
vs. proximal humerus nail multiloc?
obias Helfen
?
, Georg Siebenbürger, Evi Fleischhacker,
Ockert
of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich
r t i c l e i n f o
history:
ccepted 14 June 2020
vailable online xxx
ywords:
oximal humeral facture
11-A3
king plate
ew tip augmentation
intramedullary nail
T
ly
a b s t r a c t
Introduction: The purpose of this
plating with intramedullary nailing
humeral fractures in elderly patient
Patients and Methods: Patients
the proximal humerus were sur
tion Group LP or multiplanar intr
Disabilities of the Shoulder, Arm
ters were the age- and gender
Score (ASES), the Oxford Shoulder
months, 12 and 24 months. Further
plications and revision surgeries.
followed over 24 months (follo
Results: The mean DASH-Scores
in Group IN ( p = 0.04). The mean
in Group LP compared to 72 ±
75.1 ± 9 points in Group LP ve
43.7 ± 8.1 in Group LP compar
74.7 ± 12.5 in Group LP versus
n = 2 (6,7%) cases of Group LP
n = 2 (6.7%) cases of Group L P
Conclusion: Functional outcomes
augmentation compared to intr
sion rates for two-part surgical
anatomic fracture reduction and
oduction
Proximal humeral fractures are the second most common frac-
e of the upper limb and the third most common fracture in the
ly [1,2] . In turn, 65% of patients with a proximal humeral frac-
e are > 60 years of age [3] . In the light of demographic change,
incidence of proximal humeral fracture is expected to rise, as
?
Corresponding author.
E-mail address: tobias.helfen@med.uni-muenchen.de (T. Helfen).
Kannus
gr
et
[3]
or
functional
sur
pr
dence
be
g/10.1016/j.injury.2020.06.026
020-1383/? 2020 Elsevier Ltd. All rights reserved.
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
y
.com/locate/injury
type fractures of the
ugmented locking plate
Johannes Gleich, Wolfgang B?cker,
, Germany
prospective randomized controlled clinical trial was to compare locked
in the treatment of displaced 2-part surgical neck type proximal
s.
≥60 years of age with a displaced 2-part surgical neck type fracture of
gically treated and randomized for either augmented locking plate fixa-
amedullary nailing Group IN . The primary outcome parameter was the
and Hand (DASH) Score after 24 months. Secondary outcome parame-
adjusted Constant Murley Score (CS), the American Shoulder and Elbow
Score (OSS) and the Short Form 36 (SF-36) after 6 weeks, 3 months, 6
parameters included the quality of fracture reduction as well as com-
60 patients with a mean age of 75 ±9.8 were included and longitudinally
w-up rate: 83.3%).
at 24 months was 32.6 ± 9.7 points in Group LP versus 37.8 ± 8.3 points
Constant Murley Score at 24 months follow-up was 76.2 ± 7.7 points
9.1 points in Group IN ( p = 0.08). The ASES at 24 months follow-up was
rsus to 73.5 ± 8.9 in Group IN ( p = 0.51). The OSS at 24 months was
ed to 38.2 ± 10 in Group IN ( p = 0.03). The SF-36 at 24 months was
to 70.9 ± 12.8 in Group IN ( p = 0.29). Screw cutting out was observed in
, and in none of Group IN ( p = 0.49). Revision surgery was necessary in
and in two cases of Group IN (6.7%, p = 1).
are similar at 2-years follow-up in locked plating with screw tip
amedullary nailing. Both implants reached low complication- and revi-
neck types fractures of the proximal humerus in patients ≥60 years, if
accurate implant position was obtained.
? 2020 Elsevier Ltd. All rights reserved.
et al. reported an incidence of 298 per 10 0,0 0 0 in the age
oup of at least 80 year old patients in 2007 [4] and Palvanen
al. predict an increase of fracture incidence of 50% until 2030
.
Approximately 60–80% of all humeral fractures are minimally
non-displaced and can be treated conservatively with a good
result [5] , however in gross displacement, indication for
gical treatment is suggested [6,7] . Regardless of the impact of
oximal humeral fractures for medical burden, there is little evi-
on the suggested surgical treatment [8] . In detail, the num-
r of randomized controlled trials on surgical treatment of prox-
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
2 T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
Exclusion
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with
Table 1
Inclusion- and exclusion criteria.
Inclusion criteria
?
Age: ≥60 years, or female postmenopausal
?
2-part fracture according to AO-classification (Arbeitsgemeinschaft
Osteosynthesefragen): AO 11-A3
?
Signed informed consent
?
Patient can read and understand German
imal humeral fractures is sparse. The most frequently performed
surgical technique; however, is fracture fixation by use of locking
plates. [9,10] The main risk for poor outcome in fracture fixation
is secondary fracture displacement and cutting out of the implant
[11] . Specifically, there is a high risk for secondary displacement in
2-part surgical neck-type fractures with primary displacement and
metaphyseal comminution in elderly patients with poor bone qual-
ity [12] . The primary reason for this complication seems to be in-
stability of transmetaphyseal fractures caused by loss of impaction
potential in a porous spongiosa and little bone stock for implant
anchorage [13] . Currently, various approaches are taken to avoid
secondary displacement by increasing the fixation’s strength, in-
cluding cement augmentation of screw tips and the development
of intramedullary nails enabling for multiplanar fixation [14-19] .
However, superior clinical results have not been proven and data
from prospective randomized comparison was not available.
The purpose of this clinical trial was to compare cement aug-
mented locking plate fixation versus a multiplanar humeral nail
fixation for the treatment of displaced 2-part surgical neck type
fractures in elderly patients with regards to shoulder function,
quality of life, patient satisfaction, implant stability, complication-
and revision rates.
Patients and methods
Population, screening and randomization
Sixty patients were recruited for randomization to either to
augmented plate fixation group (PHILOS
TM
with augmentation,
Group LP ) or to multiplanar intramedullary nail group (MultiLoc?,
Group IN ) at a level I trauma center. All subjects provided writ-
ten informed consent. The study was conducted at the Depart-
ment of Trauma Surgery, University of Munich (LMU), Germany, ac-
cording to the CONSORT guidelines ( Fig. 1 ). Patients were screened
within the regular emergency unit settings using the AO-Reference
for Fracture classification. Patients ≥60 years with a 2-part surgical
neck type fracture of the proximal humerus (AO type 11-A3) were
included. A correct fracture classification was ensured by CT-scans
for all participants. Inclusion and exclusion criteria are listed in
Table 1 . Within 48 h, participants were included and randomized
by sealed envelope (opaque, not resealable) drawing. Each partic-
ipant had a unique identification number and kept that number
throughout the study. Sequence generation was performed by on-
line Statistical Computing Web Program: www.randomization.com .
A total of n = 60 patients with a mean age of 75 ±9.8 years that
were treated in our institution between November 2015 to Decem-
In
pr
diame
German
sta
subcortical
cal
scr
T
scr
fa
wa
in
gitudinall
scr
scr
pos
planar
of
cor
fa
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
criteria
efusal to participate in the study
Independent
and/or institutionalized
not understand written and spoken guidance German
athologic fracture or a previous fracture of the same proximal humerus
or drug addiction, e.g., in the emergency department, breathalyzer
es blood alcohol concentration of more than 2%
injury to the same upper limb requiring surgery
jor nerve injury (e.g., complete radial- or axillary nerve palsy)
tator cuff tear arthropathy
fracture
auma or -fractured patient
acture dislocation or head-splitting fracture
on-displaced fracture
ed fracture of the major or minor tubercle
y medical condition that excludes surgical treatment
egnancy
r 2017 were included. Of 30 patients of Group LP, n = 21 (70%)
re female, and of the 30 patients of Group IN, n = 20 were fe-
(66.7%), ( p = 1). The mean age of patients was 76.3 ± 8.9
Group LP and 73.7 ± 10.4 in Group IN ( p = 0.24). The demo-
aphic characteristics were comparable among each group and did
t differ significant in sex and age.
erventions
All fractures were initially immobilized by a Gilchrist-sling. This
s the same procedure as for patients who did not attend this
Temporary immobilization was performed by the doctor on-
in the emergency room. Patients were admitted to the trauma
rd after that. On the same day or at the latest one day after the
s were informed about the study, screened, included and
andomized by one of the study investigators to the trial. The pa-
were allowed to make their decision within 24 h.
Operative treatment was exclusively performed by the study in-
stigators ( N = 4), senior trauma surgeons ( ≥50 shoulder surg-
per year), experienced with both devices in the treatment of
oximal humeral fractures. In group LP surgical fracture fixation
s achieved by use of the angle plate fixation system PHILOS
TM
screw tip augmentation (DePuy Synthes, Umkirch, Germany).
patients of Group IN the fracture was fixed by the multiplanar
oximal humeral nail MultiLoc? with the length of 160 mm and a
ter according to the humeral shaft (DePuy Synthes, Umkirch,
y). For the plate fixation ( Group LP ) screws were set in a
ndardized fashion: Deltopectoral approach. Seven screws placed
in row A, B, D and F as well as 3 screws bicorti-
in the shaft (one proximal non-locking and two distal locking
ews). The screws in row A and E were augmented with 0.5 ml
raumacem V + (DePuy Synthes, Umkirch, Germany). Alternatively,
ews in row B and D were augmented, if the patient’s anatomy
vored a more central screw tip augmentation. The MultiLoc? nail
s inserted in a standardized fashion through a minimal incision
vasive skin incision via the supraspinatus tendon, which was lon-
y incised and sutured thereafter. Three 4.5 mm MultiLoc?
ews at levels A, B and D were inserted. Two additional 3.5 mm
ew-in-screws were optionally used at levels A and B and aimed
teriorly. In the shaft one ascending calcar screw and two multi-
distal locking screws were implanted in all patients. Lengths
all screws were estimated likewise for both devices and in ac-
dance with the surgical technique recommended by the manu-
cturer.
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx 3
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
P
acti
b
ev
the
mo
Outcome
Shoulder
secondar
jus
bo
Fo
24
the
gr
Fig. 1. Flow diagram of patient enrolment and
ost-surgical rehabilitation
The post-surgical rehabilitation protocol allowed passive and
ve-assisted motion exercises, supervised by a physical therapist,
eginning immediately on day one after surgery. Abduction and el-
ation were limited to 60 °, without forced external rotation for
first 6 weeks, followed by active exercises with full range of
tion and increasing strength exercises.
parameters and follow-up
The primary outcome parameter was the Disabilities of the
, Arm and Hand (DASH) Score after 24 months [20] . The
y outcome parameters were: the age- and gender ad-
ted Constant Murley Score (CS) [21] , American Shoulder and El-
w Score (ASES) [22] , Oxford Shoulder Score (OSS) [23] and Short
rm 36 (SF 36) [24] after 6 weeks, 3 months, 6 months, 12 and
months.
Radiographic evaluation of fracture fixation was obtained from
postoperative true anteroposterior (AP) and outlet-view radio-
aphs of the shoulder conducted within three days from surgery,
in
al
shaf
dial
fr
of
fr
ra
ies
mination
accor
duction,
Ev
months,
and
t
months,
of
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
analysis n = number, FU = follow-up .
all patients. The blinded AP radiographs were retrospectively an-
yzed by two examiners for quality of fracture reduction (head-
t displacement, head-shaft alignment) and integrity of the me-
calcar hinge.
The criteria for the quality of fracture reduction were adopted
om previous studies [25,26] : A minor varus head-shaft alignment
< 120 ° to 110 ° was considered to be an acceptable result of
acture reduction, a head-shaft alignment of < 110 ° or > 150 ° was
ted as malreduction which is in agreement with previous stud-
[27-29] . Under these considerations of the quantitative deter-
of fracture reduction, patients were assigned in 3 groups
ding to Schnetzke et al. [30] : Overall anatomical fracture re-
acceptable fracture reduction and malreduced fracture.
aluation took place immediately after surgery, after 6 weeks, 3
6 months, 12 and 24 months.
Complications were recorded from the day they were observed,
revision surgery was likewise documented when it was ob-
ained. Follow-up examinations were conducted after 6 weeks, 3
6 months, 12 and 24 months, while there was no blinding
outcome assessment.
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
4 T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
Ta
The
der
(ASES),
1
months,
LP
wa
(
Group LP compared to 70.9 ± 12.8 in Group IN ( p = 0.29). ( Fig. 2 A-
F, Table 3 ).
Radiographic evaluation
Anatomical fracture reduction was achieved in n = 15 (50%)
patients of Group LP compared to n = 13 (43.3%) of Group IN
( p = 0.79) ( Fig. 3 ). Acceptable fracture reduction was achieved in
n = 11 (36.7%) of Group LP compared to n = 12 (40%) of Group IN
( p = 1). Malreduced fractures were found in n = 4 (13.3%) patients
of Group LP compared to n = 5 (16.7%) of Group IN ( p = 1).
The mean CCD-angle immediately after surgery was 129.6 °±7.9 °
in Group LP compared to 131.4 °±11 ° in Group IN ( p = 0.51) and
127.5 °±7.3 ° in Group LP compared to 123.5 °±17.3 ° in Group IN af-
ter 24 months of follow-up ( p = 0.45). Secondary displacement
over the follow-up period was 2.1 °±7.9 ° ( p = 0.07) in Group LP
compared to 8 °±10.2 ° p = 0.06) in Group IN . No relationship be-
tween age ( p = 0.52), CCD-angle (0.91) and functional outcomes
was found.
Implant specifics and complications
The screw tip augmentation was used in 3.2 ± 0.7 (35.6%)
Table 2
Baseline factors of both groups.
PHILOS
TM
augm. MultiLoc? P value
Age (years) 76.3 ± 8.9 73.7 ± 10.4 0.3
Proportion female 19/30 (63.3%) 21/30 (70%) 0.78
Time to surgery (days) 2.9 ± 2.1 2.4 ± 1.4 0.28
Sample size estimation and statistical analysis
Primary outcome of this study was the DASH-Score (0–100
points, 0 (no disability) to 100 (most severe disability)). In a case
number calculation for unpaired samples and target figures, an
effect size of a difference of 15 points at the highest, with a
standard deviation of 15 points was assumed. A difference of 15
points was seen as a minimal clinically important difference Fol-
lowing parameters are the results: Delta = 15, SD = 15, alpha = 0.05,
power = 0.8. N = 40 patients should be included according to the
above-mentioned calculation. The sample size estimation based on
findings from Gummerson et al. [31] who reviewed 92 trials of
upper extremity disorders published in 4 journals over 11 years.
The article describes the minimal detectable change in DASH as 10
points with an SD of 13 with a mean score of 15 points. To protect
the quality of our study the drop-out rate was limited to a maxi-
mum of 20% (e.g. 3 patients per group).
Standard deviations or confidence intervals of percentages were
provided for each type of epidemiological data. The assumption
of normality was verified by the Shapiro-Wilk test for the use of
parametric tests. A Pearson’s chi-square test was employed to an-
alyze results from the two groups involving categorical variables.
A Student’s (parametric) t -test was used for comparing groups of
numeric variables. Paired t-tests (parametric) and Wilcoxon tests
(non-parametric) were used to compare clinical progression at
follow-up intervals. The significance level used in all statistical
tests was set to 5% (alpha = 0.05), with tests having a p-value less
than 0.05 being stated statistically significant. Patients requiring
revision surgery were monitored and their results computed in the
primary assignment group (intention-to-treat principle). Provisions
were made for blinded statistical analysis of data by a statistician
who was unfamiliar with the objectives and outcomes of interest.
Trial registration
The study was conducted in accordance with the recommenda-
tions of the Declaration of Helsinki and was approved by the Ethi-
cal Committee of the Medical University of Munich (#510–15). The
trial was registered at www.ClinicalTrial.gov before the first pa-
tient was included, and updated during the inclusion period, the
follow-up and after inclusion of patients, ClinicalTrials.gov Identi-
fier: NCT02609906.
Results
A total of n = 50 (83.3%), 25/30 of each group completed the
24 months of follow-up. N = 10 patients were lost to follow-up
( n = 5 of Group LP, n = 5 of Group IN ). Follow-up was conducted
at a mean of 5.9 ± 2.1 weeks, 3.1 ± 0.2, 6.3 ± 1.5, 12.2 ± 2 and
24.3 ± 2.6 months. Baseline factors of both groups are shown in
table 2 .
Functional outcome
At 24 months follow-up the mean DASH-Scores was 32.6 ± 9.7
points in Group LP compared to 37.8 ± 8.3 points in Group IN
( p = 0.04). The mean Constant Murley Score was 76.2 ± 7.7 in
Group LP compared to 72 ± 9.1 points in Group IN ( p = 0.08).
The ASES at 24 months follow-up was 75.1 ± 9 points in Group
scr
scr
(
sitioning
sur
of
serv
(6,7%)
Gr
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
ble 3
Disabilities of the Arm, Shoulder and Hand (DASH) Score, the age- and gen-
adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score
the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36) for Group
(PHILOS
TM
with augmentation) and Group 2 (MultiLoc?) at 6 weeks, 3 months, 6
12 and 24 months including the P-values.
Score Follow-up PHILOS
TM
augm. MultiLoc? P value
DASH ± SD 6 weeks 53.7 ± 12 57.8 ± 14.5 0.23
3 months 47.2 ± 11.2 50.8 ± 12.6 0.24
6 months 40.1 ± 8.3 44.1 ± 11.5 0.13
12 months 34.3 ± 8.1 37.9 ± 9.2 0.13
24 months 32.6 ± 9.7 37.8 ± 8.3 0.04
CS ± SD 6 weeks 45.3 ± 9.2 42.9 ± 14.2 0.55
(age- and gender
adjusted)
3 months 46.7 ± 12 48.6 ± 8.9 0.53
6 months 63.4 ± 10.7 62.2 ± 9.7 0.89
12 months 75.8 ± 8.8 73.6 ± 9.7 0.38
24 months 76.2 ± 7.7 72 ± 9.1 0.08
ASES ± SD 6 weeks 44.5 ± 12.3 42.8 ± 9.7 0.53
3 months 47.6 ± 11.2 45.9 ± 9.4 0.33
6 months 64.3 ± 9.8 63.9 ± 11.4 0.92
12 months 72.8 ± 7.6 72.7 ± 8.9 0.58
24 months 75.1 ± 9 73.5 ± 8.9 0.51
OSS ± SD 6 weeks 23.7 ± 6.7 21.2 ± 8.2 0.2
3 months 25.2 ± 6.2 23.7 ± 8.3 0.43
6 months 33.2 ± 5.1 31.2 ± 7.2 0.27
12 months 40.8 ± 6.8 35.2 ± 9.2 0.1
24 months 43.7 ± 8.1 38.2 ± 10 0.03
SF 36 ± SD 6 weeks 61.4 ± 9.4 60.1 ± 8 0.56
3 months 63 ± 9.5 58.2 ± 8.1 0.03
6 months 67.1 ± 10.2 62 ± 9.5 0.04
12 months 74.3 ± 9 71.7 ± 9.5 0.22
24 months 74.7 ± 12.5 70.9 ± 12.8 0.29
compared to 73.5 ± 8.9 in Group IN ( p = 0.51) and the OSS
s 43.7 ± 8.1 in Group LP compared to 38.2 ± 10 in Group IN
p = 0.03), respectively. The SF-36 at 24 months was 74.7 ± 12.5 in
ews without intraarticular cement leaking in Group LP . The
ew-in-screw option was used in n = 9 (30%) cases of Group IN
p = 0.54). Immediately after surgery two cases of implant malpo-
in Group IN (6.7%) were detected, of which one has been
gically revised with a reversed fracture prosthesis, and no case
screw- or implant malposition in Group LP ( p = 0.49) was ob-
ed. Screw-cut out during the follow-up was registered in n = 2
cases of Group LP , of which one was surgically revised (3.3%).
oup IN was without any screw-cut outs ( p = 0.49). One patient
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx 5
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
F
[P
PHIL
of
out
ve
Discussion
cal
ing
imal
port
ig. 2. A : CCD-Angles [ °] over the follow-up points. B : DASH Score [Points] over the follo
oints] over the follow-up points. E : OSS [Points] over the follow-up points. F : SF-36 [Point
OS
TM
with augmentation MultiLoc? .
Group IN experienced an additional fall 6 weeks after surgery,
of this a peri implant fracture necessitated conversion to a re-
rse total shoulder arthroplasty ( Fig. 4 ).
The purpose of this prospective randomized controlled clini-
trial was to compare locked plating with intramedullary nail-
in the treatment of displaced 2-part surgical neck type prox-
humeral fractures in elderly patients. One of the most im-
ant findings of this trial is that both, the locked plating with
cement
tiplanar
tion
The
the
(SF-36:
bo
displace
g
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
w-up points. C : Constant Score [Points] over the follow-up points. D : ASES Score
s] over the follow-up points.
augmentation of screw tips and the intramedullary mul-
nail, were found comparable in recovering shoulder func-
after a 2-part surgical neck type fracture in elderly patients.
results of this trial showed no significant differences between
study groups in terms of quality of life at 24-month follow-up
74.7 vs. 70.9).
Several studies demonstrated good functional outcomes for
th locking plates and intramedullary nails in the treatment of
d proximal humeral fractures [32-35] . Zhu et al. found
ood functional results with either implant (PHILOS
TM
without
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
6 T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
Fig. 3. 2-part surgical neck type fracture of the proximal humerus (AO 11-A3). A:
preoperative x-ray of a 65-years old female. B: X-ray in AP view after 24 months
with anatomical healing. C: preoperative x-ray of a 69-years old male. D: X-ray in
AP view after 24 months with anatomical healing.
augmentation vs. Proximal Humeral Nail (PHN)) in the treatment
of 2-part-fractures of the proximal humerus [33] . The study col-
lective, however, was almost two decades younger in comparison
to the present trial [12] . Plath et al. analyzed a comparable age
cohort in an RCT comparing a locking plate (PHILOS
TM
) vs. an
multiplanar locking blade nail (LBN). A trend towards better func-
tional outcomes in locked plating at certain time points may be
explained by a higher rate of anatomically reduced fractures. We
found a greater quality of fracture reduction in Group LP, although
differences were not significant. While generally speaking, open re-
duction and internal fixation may be related to a better visualiza-
tion and improved fracture reduction, the results of this study may
rather be explained by a greater experience with the locking plates
in our department. However, reduction quality was similar to pre-
viously published studies, improving the anatomy of the proximal
humerus and leading to satisfactory functional outcomes with both
implants in 2-part surgical neck type proximal humeral fractures in
elderly patients [30] .
Implant related complications were found in both study groups.
Screw-cut out was noted in n = 2 (6,7%) of Group LP . Doshi et al.
[36] published an approximate amount of 5.6% cut-out of screws in
a cohort with a mean age of 54.4 years, without the augmentation.
Owsley et al. reported 23% screw-cut outs in a cohort comparable
to
ondar
ma
ment
scr
no
necr
wa
point,
re
cases
by
a
thors
get
in
tions
to
Ho
Fig. 4. Selected complications of both groups A: Distal screw cutting out without new tra
with a 5-hole PHILOS
TM
with augmentation. B: Peri implant fracture of an 80 years old male
a reverse total shoulder arthroplasty.
Please cite this article as: T. Helfen, G. Siebenbürger and E. Fleischhacker
of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
our patients age [37] . As cutting out of screws is related to sec-
y displacement, the comparably low rate of screw cut-outs
y be explained by an increased stability due to screw-tip aug-
ation. Previous studies proved higher fixation strength when
ew- tips were augmented with cement. Nevertheless, there was
case of intraarticular cement leakage and no case of avascular
osis secondary to screw-tip augmentation. Implant malposition
s found in two cases of Group IN, due to an incorrect entry
one of these was indicated to surgical revision. Plath et al.
ported malposition of intramedullary nails in 14.3% [35] . The two
of an incorrect entry point in the present study were caused
limited approachability by obesity which has to be anticipate as
challenging factor of the insertion maneuver of the nail. The au-
remark an occasional missing of the calcar screw in its tar-
area, especially in small humeral heads screw can be located
the proximal shaft region ( Fig. 3 ). The overall rate of complica-
in this study needs to be considered, however, with regards
patients’ age, regional bone quality and fracture patterns [33] .
wever, both implants resulted in a high rate of fracture union
uma of a 62 years old female after 8 weeks. Surgical revision was re-osteosynthesis
after fall on the left shoulder 6 weeks after. Surgical revision was conversion to
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
T. Helfen, G. Siebenbürger and E. Fleischhacker et al. / Injury xxx (xxxx) xxx 7
ARTICLE IN PRESS
JID: JINJ [m5G; July 3, 2020;1:53 ]
with
to
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elder
bility
the
uals,
yo
>
the
af
up
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in
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ot
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Conclusion
tiplanar
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Re
[20]
[22]
[23]
[2
[25]
[26]
[28]
[29]
[30]
[32]
[3
[34]
[3
[36]
a reasonable low complication rate and were found suitable
regain the patient autonomy in geriatric setting.
The strengths of this study is its prospective and randomized
olled design. With n = 60 participants during the scheduled
cruitment phase, 30% more participants were included, than re-
ired by the case number calculation. However, there are limita-
to this study that needs to be considered. As a study in an
ly cohort has a high variability of preexisting general immo-
and comorbidities not all patients could be examined until
final follow-up [38] . However, in a study of elderly individ-
the dropout rate is generally higher compared to studies of
unger individuals, and the follow-up was fully accomplished in
80% of patients. Finally, only 2-part surgical neck type fractures of
proximal humerus were included. Complication rates reported
ter locking plate fixation of proximal humeral fractures still range
to 40% [11] . Modifications of surgical techniques, use of primary
arthroplasty, or a fracture-specific management resulted
decreased complication rates during recent years. [39] Conse-
ently, recommendation of both implants cannot be presumed on
her, more complex fracture types and alternative surgical tech-
ues must be considered.
Further studies are needed to get to know the two implant
and their strengths and weaknesses. Evaluations of the rela-
between poor reduced fractures and functional outcome,
relationship between poor reduced fractures and complication
tes as well as the influence of surgeon’s experience in the im-
s would be helpful [40] .
Locked plating with screw-tip-augmentation as well as mul-
intramedullary nailing achieve satisfying functional out-
in 2-part surgical neck type fractures of the proximal
in an elderly population at two years of follow-up. Screw
ugmentation of locking plates performs equally in terms of
y displacement and implant failure, compared to multi-
intramedullary nailing, if anatomic fracture reduction and
ate implant position is obtained. Fracture fixation maintains a
option in two part surgical neck type fractures of the elderly.
ation of Competing Interest
The authors declare that they have no known competing finan-
interests or personal relationships that could have appeared to
the work reported in this paper.
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of the proximal humerus in the elderly: Cement augmented locking plat
//doi.org/10.1016/j.injury.2020.06.026
et al., Operative treatment of 2-part surgical neck type fractures
e PHILOS
TM
vs. proximal humerus nail multiloc?, Injury, https:
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