Article

Early results in the treatment of proximal humeral fractures with a polyaxial locking plate

Abstract and Figures

We report early results using a second generation locking plate, non-contact bridging plate (NCB PH((R)), Zimmer Inc. Warsaw, IN, USA), for the treatment of proximal humeral fractures. The NCB PH combines conventional plating technique with polyaxial screw placement and angular stability. Prospective case series. A single level-1 trauma center. A total of 50 patients with proximal humeral fractures were treated from May 2004 to December 2005. Surgery was performed in open technique in all cases. Implant-related complications, clinical parameters (duration of surgery, range of motion, Constant-Murley Score, subjective patient satisfaction, complications) and radiographic evaluation [union, implant loosening, implant-related complications and avascular necrosis (AVN) of the humeral head] at 6, 12 and 24 weeks. All fractures available to follow-up (48 of 50) went to union within the follow-up period of 6 months. One patient was lost to follow-up, one patient died of a cause unrelated to the trauma, four patients developed AVN with cutout, one patient had implant loosening, three patients experienced cutout and one patient had an axillary nerve lesion (onset unknown). The average age- and gender-related Constant Score (n = 35) was 76. The NCB PH combines conventional plating technique with polyaxial screw placement and angular stability. Although the complication rate was 19%, with a reoperation rate of 12%, the early results show that the NCB PH is a safe implant for the treatment of proximal humeral fractures.
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TRAUMA SURGERY
Early results in the treatment of proximal humeral fractures
with a polyaxial locking plate
Johannes B. Erhardt ÆG. Roderer ÆK. Grob Æ
T. N. Forster ÆK. Stoffel ÆM. S. Kuster
Received: 14 January 2008
ÓSpringer-Verlag 2009
Abstract
Objectives We report early results using a second gen-
eration locking plate, non-contact bridging plate (NCB
PH
Ò
, Zimmer Inc. Warsaw, IN, USA), for the treatment of
proximal humeral fractures. The NCB PH
Ò
combines
conventional plating technique with polyaxial screw
placement and angular stability.
Design Prospective case series.
Setting A single level-1 trauma center.
Patients A total of 50 patients with proximal humeral
fractures were treated from May 2004 to December 2005.
Intervention Surgery was performed in open technique in
all cases.
Main outcome measures Implant-related complications,
clinical parameters (duration of surgery, range of motion,
Constant–Murley Score, subjective patient satisfaction,
complications) and radiographic evaluation [union, implant
loosening, implant-related complications and avascular
necrosis (AVN) of the humeral head] at 6, 12 and
24 weeks.
Results All fractures available to follow-up (48 of 50)
went to union within the follow-up period of 6 months.
One patient was lost to follow-up, one patient died of a
cause unrelated to the trauma, four patients developed
AVN with cutout, one patient had implant loosening, three
patients experienced cutout and one patient had an axillary
nerve lesion (onset unknown). The average age- and gen-
der-related Constant Score (n=35) was 76.
Conclusions The NCB PH
Ò
combines conventional
plating technique with polyaxial screw placement and
angular stability. Although the complication rate was 19%,
with a reoperation rate of 12%, the early results show that
the NCB PH
Ò
is a safe implant for the treatment of prox-
imal humeral fractures.
Keywords NCB Proximal humerus Fracture
Non-contact bridging Polyaxial locked plate
Introduction
Proximal humeral fractures are the third most common
fracture after hip and distal radius [19]. Palvanen et al. [19]
showed that the incidence and number of these fractures
has tripled within the last three decades in Finland and if
this trend continues the same can be expected for the
future. In particular, a high risk of humeral fracture results
from the combination of osteoporosis with an increased
risk of falling [16]. The management of proximal humeral
fractures has undergone transformation in the recent past
due to the emergence of innovative treatment techniques.
With the invention of locked plating, a novel biomechan-
ical approach has become available for the stabilization of
these fractures [5,7,24]. The blood supply to the humeral
head [8] prohibits medial positioning of a plate, therefore,
early loss of fixation is a commonly reported problem in
comminuted and osteoporotic fractures especially [1,13,
18]. The lateral placement of a locked implant means that
J. B. Erhardt (&)K. Grob T. N. Forster M. S. Kuster
Klinik fu
¨r Orthopa
¨dische Chirurgie, Kantonsspital St. Gallen,
9007 St. Gallen, Switzerland
e-mail: johannes.erhardt@kssg.ch
J. B. Erhardt K. Stoffel M. S. Kuster
Fremantle Orthopaedic Unit,
The University of Western Australia,
Perth, WA, Australia
G. Roderer
Abteilung fu
¨r Unfallchirurgie, Universita
¨tsklinik Ulm,
Ulm, Germany
123
Arch Orthop Trauma Surg
DOI 10.1007/s00402-009-0924-7
reduction is maintained by screws that act as struts [9].
Therefore, the indication for osteosynthesis, even for dis-
placed three and four part fractures, has increased in rela-
tion to hemiarthroplasty [11,25].
Early results for these locked plates have been published
over the last 5 years [2,11,15,20,22,23]. The most
commonly used implant reported was the Philos
Ò
plate
(Synthes). The clinical outcomes of various studies
involving this implant have been published and they all
conclude that it is suitable for use in the treatment of
comminuted fractures of the proximal humerus in osteo-
porotic bone. However, all of them also report a significant
number of complications due to screw perforation through
the humeral head and, therefore, variable re-operation
rates. Different potential solutions have been proposed
such as screw augmentation with calcium phosphate
cement in combination with both locked and conventional
plates [9,22], limited drilling in osteoporotic bone, the use
of blunt-tipped locking screws[21], and locking plates with
polyaxial screws like the non-contact bridging plate (NCB,
Zimmer)[23]. The NCB combines the properties of con-
ventional and locking plates. In this article, early results
and implant-related complications are presented for use of
the polyaxial non-contact locking (NCB
Ò
) plate, a second
generation locking device.
Materials and methods
After approval from the ethics committee had been granted,
the first 50 patients to be treated with the NCB
Ò
PH for an
acute traumatic fracture were prospectively enrolled in the
study starting in May 2004. Endpoints of the study were the
clinical and radiological outcomes and complications after
6 months. Clinical parameters included range of motion
(ROM) in flexion and abduction, and the subjective success
of the outcome was based on a high, intermediate or poor
level of patient satisfaction. Radiological parameters
included union/non-union, implant loosening, screw perfo-
ration and avascular necrosis (AVN). Exclusion criteria
were pathological fractures (caused by neoplasia), hardware
failure of other implants whereby the NCB
Ò
PH was a
revision procedure, preoperative axillary nerve damage and
inadequate follow-up. Adequate follow-up was considered
Fig. 1 Surgical technique of
indirect fracture reduction using
the plate as a buttress. Image
intensifier images and
postoperative X-rays
Arch Orthop Trauma Surg
123
adequate if the patients had documented clinical and
radiological healing or had attended all the scheduled fol-
low-up appointments. The follow-up appointments were 6,
12 and 26 weeks after the surgical procedure. The Constant–
Murley score was not included in the initial follow-up pro-
tocol. Therefore, after completing the 26-week follow-up,
each patient returned again so that their Constant–Murley
scores could be obtained [4]. The indications for surgical
treatment were all displaced three and four part fractures,
type A fractures with varus malalignment and medial com-
minution, or fractures with almost 100% displacement (type
A2 and A3 according to the AO ASIF classification).
Implant and locking mechanism
The plate is a newly designed second generation locked
implant, combining the properties of conventional plates
with the special features of locked plates. It is available in
two versions: a 4- and a 5-hole plate. The plate is suitable
for both the left and right sides. It comes with a radiolucent
targeting device so that the plate can also be inserted in
minimally invasive technique as reported by Roderer et al.
[23]. The plate can be used with solid or cannulated screws
and 4.0 mm cortical and 4.5 mm cancellous screws. This
way tactile feedback on the quality of the bone is still
given, in contrast to other locking mechanisms. Second-
arily, the screws can be locked with the NCB locking screw
with a torque of 4 Nm and up to an angle of a total of 30°.
This, in contrast to other locking mechanisms, provides no
absolute angular stability. In the study presented here
failure of the locking mechanism was not reported in
contrast to published data of failure of an absolute angular
stable implant [2,9]. The plate has oblique 2 mm holes for
the reattachment of the rotator cuff.
Surgical technique
The method of choice was open reduction through a delto-
pectoral approach in all patients. As proposed by Hertel
[12], the reduction of the fracture was performed indirectly
without dissecting the single fractured parts whenever
possible. Initially all three rotator cuff tendons were held
with non-resorbable sutures. In the majority of cases, good
reduction can be achieved by applying axial traction on the
humerus and pulling the rotator cuff, e.g. the greater and
lesser tubercles in an anterior-inferior direction, supple-
mented by use of the NCB
Ò
as an indirect reduction tool
and insertion of compression screws as illustrated in Fig. 1.
After reduction, the head screws were placed polyaxially
and as divergently as possible and then locked. This was
essential in cases of medial comminution. Finally, the
sutures were fixed through the 2 mm oblique holes in the
plate.
Postoperative regimen
In this series, all patients underwent an early passive
mobilization regimen. All patients were treated with a
restraining shoulder bandage for at least 4 weeks. In the
first 2 weeks, single pendulum exercises with passive
mobilization up to 30°were allowed with an increased
range of 90°in the third week. In the fourth week, active
mobilization without weight was performed and, finally, in
the sixth week full active mobilization was allowed.
Outcome parameters
Data were collected with regard to demographics, operative
details, and the duration of inpatient stay. Clinical and
radiological follow-up took place at 6, 12 and 26 weeks. The
patients were assessed at the 6-, 12- and 26-week follow-ups
radiologically and clinically (total shoulder movement in
flexion and abduction, subjective success of the outcome with
a high, moderate or poor level of satisfaction). Radiographic
evaluation included union, implant loosening, hardware-
related complications and AVN of the humeral head. Union
was defined in terms of the patient reporting no shoulder pain
or only mild activity-related pain and having no loss of initial
fracture reduction or evidence of implant loosening, break-
age, combined with evidence of internal or external callus
formation [22]. The Constant–Murley score was not included
in the initial follow-up protocol. Therefore, after the patients
had completed the 26-week follow-up, they were all invited
back so that a Constant–Murley score could be obtained [4].
For analysis of change of ROM from 6 to 26 weeks, an
independent samples ttest was performed using the
Table 1 The demographics of patients and fractures
Mean age in years (range) 61 (25–91)
Sex 20 Males 30 Females
Affected side 20 Right 30 Left
Fracture classification
AO/ASIF
Type A 11
Type B 21
Type C 19
Average length of surgery
in min (±SD)
76 ±29
Average length of
hospital stay in days
(±SD)
7±4
Mean follow-up in
months (range)
10 (3–22)
Injury mechanism
Body height fall 39
Road traffic accident 2 Bicycles, 4
motorbikes, 3 cars
Sport 2 While skiing
Arch Orthop Trauma Surg
123
software SSPS 15.0 for Windows with a significance
threshold of p\0.05.
Results
Clinical and radiological follow-up was possible for 48 of
50 patients. One patient failed to attend any of the follow-
up appointments and the second patient died of a cause
unrelated to the trauma. The fractures united in all 48
patients available for clinical and radiological follow-up.
The shortest follow-up period was 3 months; this patient
was content with documented clinical and radiological
healing and did not want to attend any further appoint-
ments. The demographics of the patients and the fractures
are shown in Table 1.
No adverse events were reported with regard to the
surgical procedure. The adjacent joints were mobilized
during the inpatient stay whereby, in this case series, early
mobilization of the shoulder was performed in a very
conservative way with just swinging the arm for 2 weeks
and then starting passive mobilization to 90°. The results
for average flexion and abduction (with free scapula) are
shown in Fig. 2.
After completion of the initial follow-up protocol all
patients were invited for Constant–Murley scoring [4] after
a minimum of 6 months, postoperatively. Thirty-five
patients attended this appointment. The average follow-up
period at this stage was 10 months. The average age of
these patients was 70 (47–91) years. According to the study
of Katolik [14] an age- and gender-related Constant Score
was calculated using the formula: (raw score/normal
score) 9100. We used the normal scores as presented in
the series of Katolik [3,14], which are higher values than
those Constant described initially. Therefore, the risk of
overestimating shoulder function is decreased. The results
Mean Range of Motion
0
20
40
60
80
100
120
140
160
180
200
Degrees
Flexion
Flexion
Flexion
Abduction
Abduction
Abduction
6 weeks 3 months 6 months
Fig. 2 Functional results of
flexion and abduction at
6 weeks, 3 months and
6 months after the surgical
intervention. The increase in the
range of motion between each
follow-up was significant
(p\0.05)
0
10
20
30
40
50
60
70
80
90
100
Raw Constant
Score,
Total (max.100)
Pain
(max.15)
ADL
(max.20)
ROM
(max.40)
Force
(max.25)
Fig. 3 Results of the Raw–
Constant–Murley Score (±SD)
after an average follow-up
period of 10 months. The
average score was 66 ±16 in
n=35 patients. The table
shows the four sections of the
score including pain, activities
of daily life (ADL), range of
motion (ROM), and strength
Arch Orthop Trauma Surg
123
showing an average raw score of 66 ±16 are presented in
Fig. 3. Patient data and the calculated age- and gender-
related Constant Score of 76 ±18 are given in Table 2.
In addition, the subjective level of satisfaction was
evaluated and recorded in three stages. Thirty-eight
patients showed high satisfaction at the final follow-up,
eight patients were moderately satisfied, and two patients
were dissatisfied with the treatment outcome. Implants
were removed from four patients because of an impinge-
ment syndrome.
Complications
During the follow-up period the complication rate was
18.7% (9 of 48 cases). Partial axillary nerve palsy was
reported in one case (2%). The patient with a history of
cervical fusion could not remember whether the palsy was
already present before the surgical intervention, but
because it was not clearly reported in the medical and
emergency department chart, we assumed it to be a com-
plication. In three patients (6.2%), cutout of at least one
screw through the humeral head into the joint was noted
within the first 6 weeks so that either removal of some
implants or replacement of at least one screw was required
(Fig. 4). With reference to the AO ASIF classification,
these complications occurred in 2 type C fractures and 1
type A fracture with 100% displacement. In four patients
(8.3%) partial AVN developed, which led in all cases to
screw perforation of the humeral head, requiring partial or
complete implant removal in three patients. The AO ASIF
classifications in these cases were 2 type C, 1 type B and 1
type A with 100% displacement. Implantation of a pros-
thesis was not necessary in any of these cases. Finally, in
one (2%) 91-year-old demented non-compliant patient, the
plate loosened during the inpatient stay leading to loss of
reduction of the humeral head. In the further course this
was managed non-surgically. In summary, the complica-
tion rate was 18.7% (9 of 48 cases) with a re-operation rate
of 12.5% during the follow-up period (Table 3).
Discussion
The treatment modalities for proximal humeral fractures
have increased since the introduction of fixed angled
devices. The introduction of these devices has encouraged
surgeons to decide in favor of surgical treatment, in gen-
eral, and osteosynthesis rather than a prosthesis, in partic-
ular [25]. However, non-surgical management of these
fractures still dominates in the majority of cases [10,25].
Because of the increasing incidence of this type of injury
[19] and the increasing demands on shoulder function at an
older age, the number of patients receiving surgical treat-
ment will increase in the future.
This article is based on the first 50 cases prospectively
enrolled and treated at our institution since the introduction
of the NCB
Ò
humeral plate in 2004.
Early clinical results show good clinical outcome with
variable complication rates [2,6,11,15,20,22,23]for
the locked plates. However, these authors all report a
significant number of complications due to screw per-
foration through the humeral head. A complication
occurring more commonly since the introduction of
locked implants is the cutout of screws through the
Table 2 Patient data including age, gender, raw Constant score and
age- and gender-related Constant Score
Patient Age Gender Raw Constant
Score
Age/gender-related
Constant Score
1 47 M 93 97
2 79 F 65 80
3 84 F 75 93
4 59 M 86 91
5 59 F 69 82
6 74 F 74 91
7 47 M 60 63
8 77 F 41 51
9 64 M 81 88
10 75 M 74 91
11 57 F 38 45
12 68 F 60 72
13 72 F 81 100
14 58 M 70 74
15 58 M 89 95
16 65 M 84 91
17 64 M 45 49
18 48 F 67 78
19 72 F 80 99
20 75 F 80 99
21 68 M 45 49
22 75 F 52 64
23 49 M 74 77
24 61 M 88 96
25 75 M 73 83
26 83 F 53 65
27 63 F 78 94
28 81 F 57 70
29 76 F 52 64
30 88 F 35 43
31 86 F 57 70
32 90 F 45 56
33 91 F 66 81
34 90 F 40 49
35 57 F 66 79
Arch Orthop Trauma Surg
123
calvarium because of the inability to fix the head frag-
ment in position until fracture healing is completed. This
risk seems to be especially great if the medial hinge is
not restored by reduction or, alternatively, by insertion of
an inferior-medial locking screw [9]. Charalambous et al.
[2] report a series of 25 cases treated with the Philos
Ò
plate. They present 17 acute cases and 8 cases treated
after delayed or non-union, or previous hardware failure.
They reported 15 complications in the acute group and 5
in the other group. In total, 20% of the cases needed
surgical revision. In the largest case series to date,
Kettler et al. [15] reported an overall complication rate
of 37% (65 of 176) with primary or secondary ‘‘cut out’
phenomena or implant loosening in 26% (46 of 176) in a
case series of 225 (176 available to follow-up) with a re-
operation rate of 16.4%. At the end of the study, 47
plates had been removed. Furthermore, several authors
have reported plate breakage, failure of the locking
mechanism, and backing up of locked screws [2,6,15]
for the Philos plate. For the NCB
Ò
PH Roderer et al.
[23] reported a slightly decreased rate of complications
at around 23% in a case series of 61 patients using a
minimally invasive technique, with a re-operation rate of
17%, not including the plate removals (3 patients) due to
impingement. These results are similar to those we
present for the NCB
Ò
using a delto-pectoral approach
and open reduction technique with a complication rate of
18.7% and a re-operation rate of 12.5%.
Fig. 4 These radiographs show the radiological course of an AO
ASIF 11 C2 fracture in a 47-year-old male. At the 6-week follow-up,
cutout of one screw was visible in the glenohumeral joint and
conversion to a shorter screw was performed. Ten months after the
injury the Constant score was 60
Table 3 Complications seen in 18.7% (9 of 48) patients treated with
the NCB PH for an acute proximal humeral fracture
Partial axillary nerve palsy 1 (2%)
Cutout of screw in the
glenohumeral joint
without AVN
3 (6.2%) AO/ASIF
2 Type C, 1 Type A
Cutout of screw in the
glenohumeral joint with
partial AVN
4 (8.3%) AO/ASIF
2 Type C, 1 Type B,
1 Type A
Loosening of implant and
loss of fixation
1 (2%) 1 AO/ASIF Type C
Arch Orthop Trauma Surg
123
Including our own patients treated with the NCB
Ò
,no
plate breakage or failure of the locking mechanism has
been reported to date. This might be because the NCB Plate
is slightly thicker than other plates and the locking mech-
anism with locking cap offers more resistance to backing
out of screws. Whether the absence of reported screw
breakages is thanks to the thicker screw diameter of
4.5 mm compared to other implants or to the design of the
locking mechanism is not absolutely clear. It is also not
clear whether this relative angular stability plays a bene-
ficial role in reducing the rate of screw perforations into the
joint. Another feature which might have an influence on the
rate of screw perforations into the joint is the thicker screw
diameter and the option of using cancellous screws.
The specific advantages of polyaxiality in combination
with the locking mechanism are that during drilling and
screw insertion the feel for bone quality is preserved
and the screw can be directed into an area of good bone and
then locked afterwards. Polyaxiality also facilitates the
positioning of an infero-medial screw as described by
Gardner [9].
Even if biomechanical data is confirming the benefits of
elastic properties in the fixation stability of locked plates
compared to nails and conventional plates [17], no rec-
ommendations have yet been validated by biomechanical
data on how to position the screws in the humeral head to
achieve maximal fixation stability, especially with poly-
axial second generation locking plates.
A limitation of this study is that this case series only
yields preliminary results with an endpoint of the study
after 6 months. Even though the clinical and radiological
follow-up rate was 96% a Constant–Murley score was only
obtained for 72% of the patients. However, without
exception all fractures united during the follow-up period
in the patients available to follow-up (48 of 50) and, in our
experience, implant-related complications generally occur
in the early postoperative period. It is not possible to
comment on the later development of total or partial AVN,
whereby the rate of 8.3% recorded for our series is much
lower than the rate of 16% obtained by Hente et al. [11]in
their series for a similar distribution of fracture patterns.
This might be related to the short follow-up period.
Another limitation of this study is the lack of a comparative
group. On the basis of the prospective follow-up of the first
50 cases, it is certainly a reliable documentation of the
treatment outcomes that can be achieved in a cohort
comprised of 83% AO ASIF type B or C proximal humeral
fractures when these are managed by application of a
second generation locking device. This report also provides
an almost complete picture of this prospective case series
since the ‘‘fate’’ of only one implant is unknown.
As various authors state, no prospective clinical trials
have been conducted to date to compare locked implants
with polyaxial locked implants or even conventional plates
or non-surgical treatment [10]. The treatment of proximal
humeral fractures remains a challenge despite the expan-
sion of treatment options since the introduction of locked
plates. There is still great potential to improve the out-
comes, especially in terms of decreasing the rates of fixa-
tion failure and cutout.
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... With the introduction of promising preliminary results using anatomically preshaped locking plates for proximal humerus fractures (PHF), 23,26,58 these became the mainstay of operative treatment. 1,6,13,15,50,58 However, the increased use of these plates is accompanied by high complication rates 30,32,41,54,55,58 that might result in difficult revision cases with limited outcome. 22,29 Thus, the operative treatment for PHF has been questioned, and randomized controlled trials have not shown any significant functional benefit for surgery compared with nonsurgical treatment. ...
... In these patients, the aim is to achieve maximal shoulder function, according to the current literature. 3,4,13,14,19,20,25,31,42,43,45,51 The second part of the algorithm considers elderly patients, usually older than 65 years (Fig. 2). 51 In the first step, their activity level and general health status are assessed. ...
... Primary arthroplasty pathways (nos. 11,13,14,15) were used correctly in 70% (7/10) with preferred RTSA treatment as the main reason for deviation (Table I). ...
Article
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Background: On the basis of patients' demands, bone quality, and fracture type, we developed an evidence-based treatment algorithm for proximal humerus fractures (PHF)that includes all treatment modalities from open reduction and internal fixation, hemiprosthesis, to reverse total shoulder arthroplasty. This study was done to assess its feasibility and early clinical outcome. Materials and methods: Patients with isolated PHF in 2014 and 2015 were included in this prospective study. The quality of life (EQ-5D)and the level of autonomy before injury were recorded. The fractures were classified and local bone quality was measured. When possible, patients were treated according to the algorithm. Radiographic and clinical follow-up—Constant score, subjective shoulder value, and EQ-5D—took place after 3 months and 1 year. The rate of unplanned surgery was analyzed. Results: A total of 192 patients (mean age 66 years; 58 male, 134 female)were included. Of these, 160 (83%)were treated according to the algorithm. In total, 132 patients were treated conservatively, 36 with open reduction and internal fixation and 24 with reverse total shoulder arthroplasty or hemiarthroplasty. Generally, the mean EQ-5D before trauma and 1 year after treatment was equal to 0.88 to 0.9 points. After 1 year, the overall mean relative Constant score was 95% and mean subjective shoulder value 84%. Unplanned surgery was necessary in 21 patients. Conclusion: This comprehensive algorithm is designed as a noncompulsory treatment guideline for PHF, which prioritize the patient's demands and biology. The high adherence proves that it is a helpful tool for decision making. Furthermore, this algorithm leads to very satisfying overall results with low complication and revision rates.
... Different surgical treatments have been shown to provide better functional outcomes after 1 and 3 months of followup compared with conservative treatment based on 3 weeks of complete immobilization. 4,6,12,16,23,25,27,28 Nonsurgical treatment usually involves a period of immobilization, such as in an arm sling, followed by physiotherapy. 23,25,27 Immobilization of the injured limb provides support and pain relief during healing. ...
... We considered the following parameters from a true anteroposterior (AP) view radiograph with the palm of the hand facing and touching the belly: (1) head-diaphysis angle, (2) medial metaphysis displacement, and (3) greater tuberosity height (Fig. 4). 12 The head-diaphysis angle is the angle defined by the perpendicular line to the humeral shaft axis and the line defined by the most medial and most lateral points of the humeral head articular surface on a shoulder AP view. The anatomic head-diaphysis angle value is between 55°and 30°(the anatomic valgus angle of the head minus 90°). ...
Article
Background: Nonoperative management of proximal humeral fractures (PHFs) is the most common treatment, but its functional outcome may improve with early mobilization. In frail osteoporotic patients, quick recovery of prefracture independency is mandatory. This study assessed fracture displacement in PHFs managed with conservative treatment after early mobilization and a home-based self-exercise program. Methods: We retrospectively analyzed the radiologic displacement of fracture fragments of PHFs treated conservatively with early mobilization and a home-based self-exercise program. Results: Included were 99 patients with 26 one-part, 32 two-part, 32 three-part, and 9 four-part PHFs managed conservatively, followed by early mobilization and a home-based self-exercise program. In the x-ray examinations, the head displaced from varus into valgus 55° ± 23° to 42° ± 22°, in the normal range of anatomic values. The medial hinge displaced from medial to the diaphysis (+1 ± 6 mm) to lateral to the head (-0.6 ± 6 mm). The greater tuberosity displaced cranially from -1 ± 7 mm to 2 ± 5 mm. The Constant score at the 1-year follow-up was 79.69 ± 16.3. Discussion and conclusions: The home-based self-exercise program for conservative treatment of PHFs displaces the head-diaphysis angle and the medial hinge toward anatomic reduction, but there is a risk of greater tuberosity cranial displacement. Functional results are fairly good, allowing frail patients to keep on with their independency and life style. Because a large number of patients might need further physiotherapy, the quality of the home-based self-exercises should be supervised.
... Towards subject-specificity, some plates utilize variable-angle locking designs, but even for these, the screw orientations providing optimal fixation stability remain unknown. Several studies have investigated the biomechanical behavior of locking plates with polyaxial screw holes, allowing a screw angulation range of 30-40° (Erhardt et al., 2009;Ruchholtz et al., 2011;Voigt et al., 2011;Zettl et al., 2011;Erhardt et al., 2012). However, the orientation of the screws within the humeral head were chosen by the surgeon during instrumentation based on intuition and thus the highest stability was potentially not achieved. ...
Article
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Joint-preserving surgical treatment of complex unstable proximal humerus fractures remains challenging, with high failure rates even following state-of-the-art locked plating. Enhancement of implants could help improve outcomes. By overcoming limitations of conventional biomechanical testing, finite element (FE) analysis enables design optimization but requires stringent validation. This study aimed to computationally enhance the design of an existing locking plate to provide superior fixation stability and evaluate the benefit experimentally in a matched-pair fashion. Further aims were the evaluation of instrumentation accuracy and its potential influence on the specimen-specific predictive ability of FE. Screw trajectories of an existing commercial plate were adjusted to reduce the predicted cyclic cut-out failure risk and define the enhanced (EH) implant design based on results of a previous parametric FE study using 19 left proximal humerus models (Set A). Superiority of EH versus the original (OG) design was tested using nine pairs of human proximal humeri (N = 18, Set B). Specimen-specific CT-based virtual preoperative planning defined osteotomies replicating a complex 3-part fracture and fixation with a locking plate using six screws. Bone specimens were prepared, osteotomized and instrumented according to the preoperative plan via a standardized procedure utilizing 3D-printed guides. Cut-out failure of OG and EH implant designs was compared in paired groups with both FE analysis and cyclic biomechanical testing. The computationally enhanced implant configuration achieved significantly more cycles to cut-out failure compared to the standard OG design (p < 0.01), confirming the significantly lower peri-implant bone strain predicted by FE for the EH versus OG groups (p < 0.001). The magnitude of instrumentation inaccuracies was small but had a significant effect on the predicted failure risk (p < 0.01). The sample-specific FE predictions strongly correlated with the experimental results (R2 = 0.70) when incorporating instrumentation inaccuracies. These findings demonstrate the power and validity of FE simulations in improving implant designs towards superior fixation stability of proximal humerus fractures. Computational optimization could be performed involving further implant features and help decrease failure rates. The results underline the importance of accurate surgical execution of implant fixations and the need for high consistency in validation studies.
... Moreover, the expectation of an improved quality of life has increased the activity level and demands from aged osteoporotic patients [17]. Fixation of osteoporotic proximal humeral fractures using polyaxial locking plates with minimally invasive surgery (MIS) has been reported to provide stable osteosynthesis with a well-tolerated surgical insult to this cohort of patients [18,19]. Such a strategy is thought to facilitate immediate physiotherapy treatment and prompt recovery. ...
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Introduction: The objectives of this study were to describe the surgical technique of fixation of 3-4 part proximal humeral fractures with polyaxial locking plates utilising a minimally invasive approach and to evaluate the accuracy of reduction and stability of fixation. Patients and methods: We retrospectively reviewed 90 patients. Fractures were classified according to the Neer classification system. Different radiological parameters were measured to assess the quality of reduction and the stability of fixation. Complications and clinical outcomes were evaluated after one year of minimum follow up. Results: There were 76 women and 14 men, with a mean age of 67.4years ±13 (range, 29-85). There were 60 3-part and 30 4-part fractures. Frozen cancellous allograft was used in 30 cases (33.3%). All fractures progressed to union and at one year follow up, the mean Constant score was 79.6±12(range, 62-100). Mean forward flexion, abduction, external rotation and internal rotation were 155°, 148°, 39° and vertebra Dorsal 8, respectively. Complications were noted in seven patients while the postoperative "head-diaphysis angle", "greater tuberosity height" and "medial metaphysis reconstruction" were close to the anatomical parameters; no significant differences were noted at one year radiological follow up. Conclusion: Reliable and stable fixation can be expected with the use of polyaxial locking plate through a minimally invasive approach for the treatment of 3-4 part proximal humeral fractures. Satisfactory functional results for this procedure can be obtained.
Article
Introduction The management of proximal humeral fractures ranges greatly from conservative management to surgical treatment. For those fractures requiring surgical treatment, internal fixation is the primary method. The aim of internal fixation is to achieve rigid fracture fixation until union occurs, return of shoulder range of motion, and minimise intra-and postoperative complications. The aim of this study was to evaluate the results of the Proximal Humeral Interlocking System Plate (PHILOS) used for the treatment of three-and four-part proximal humeral fractures. Materials and methods This study included 30 patients with a mean age of 54 years (range 20-80 years). Results were checked post-operatively with standard radiographs and clinical evaluation according to the Constant-Murley shoulder score. All patients were followed up for 12 months. Results Union was achieved in all patients with a mean neck/shaft angle of 130° (range 108°-150°). The mean Constant-Murley score at the final follow-up was 82.28 (range 67-96) correlating with good results. No patients developed an intraoperative or postoperative vascular injury, wound complications, or avascular necrosis of the humeral head. Conclusion Our study has shown that the surgical treatment of three- and four-part proximal humeral fractures with the use of the PHILOS plate leads to a good functional outcome. It has also demonstrated the PHILOS plate and is an effective system for fracture stabilisation provided the correct surgical technique is used with awareness of potential hardware complications.
Article
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Background Multiple studies have reported an unacceptable implant-related complication rate in proximal humeral fractures treated with locking plates, particularly in older patients. Our objective was to compare the fracture fixation failure rates in elderly patients, after a dedicated technique for locking plate fixation with cement augmentation or without it. Methods A total of 168 ORIF (Open Reduction and Internal Fixation) with Locking plates were performed for complex proximal humerus fractures by a single surgeon in 136 females and 32 males over 65 years old (average 76). Treatment groups included: Group-1 non-cemented screws (n=90) and Group-2 cemented screws (n=78). According to Mayo-FJD Classification there were 74(44%) Varus Posteromedial Impaction, 41(24%) Valgus impaction, 46(28%) Surgical Neck and 7(4%) Head Dislocation injuries. A retrospective radiographic and a clinical analysis was performed Results At mean follow-up of 33 months, the implant failure rate was significantly lower in the cement augmentation group (1%vs8%, p=0.03). The overall complication rate was 21% (25% group-1, 15% Group-2 p=0.1). Global avascular necrosis was associated with sustaining a valgus impacted fracture (p=0.02 Odds-ratio 5.7), but not to augmentation. Partial avascular necrosis occurred only in patients treated with cemented screws (3.8%). The overall revision rate was 9% in both groups. Forward elevation was 126±36 degrees and external rotation was 44±19 degrees. Mean Constant Score was 70±15 in Group-1 and 76±15 in Group-2 (p=0.03) Conclusion Cement augmentation significantly decreased the rate of implant failure. Good results are expected for the majority of patients treated with this technique.
Article
Background: Previous studies have identified risk factors for different types of treatment of proximal humeral fracture (PHF) and allowed the development of a patient-specific, evidence-based treatment algorithm with the potential of improving overall outcomes and reducing complications. The purpose of this study was to evaluate the results and complications of treating PHF using this algorithmic approach. Methods: All patients with isolated PHF between 2014 and 2017 were included and prospectively followed. The initial treatment algorithm (Version 1 [V1]) based on patients' functional needs, bone quality, and type of fracture was refined after 2 years (Version 2 [V2]). Adherence to protocol, clinical outcomes, and complications were analyzed at a 1-year follow-up. Results: The study included 334 patients (mean age, 66 years; 68% female): 226 were treated nonoperatively; 65, with open reduction and internal fixation (ORIF); 39, with reverse total shoulder arthroplasty (RTSA); and 4, with hemiarthroplasty. At 1 year, the preinjury EuroQol 5-Dimension (EQ-5D) values were regained (0.88 and 0.89, respectively) and the mean relative Constant Score (CS) and Subjective Shoulder Value (SSV) (and standard deviation [SD]) were 96% ± 21% and 85% ± 16%. Overall complications and revision rates were 19% and 13%. Treatment conforming to the algorithm outperformed non-conforming treatment with respect to relative CS (97% versus 88%, p = 0.016), complication rates (16.3% versus 30.8%, p = 0.014), and revision rates (10.6% versus 26.9%, p < 0.001). Conclusions: Treating PHF using a patient-specific, evidence-based algorithm restored preinjury quality of life as measured with the EQ-5D and approximately 90% normal shoulders as measured with the relative CS and the SSV. Adherence to the treatment algorithm was associated with significantly better clinical outcomes and substantially reduced complication and revision rates. Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Article
Introduction: Bilateral acute proximal humerus fractures are rare. There are no data available about these bilateral injuries. The aim of the study was to analyse bilateral proximal humerus fractures retrospectively in terms of incidence, complications and revisions. Methods: All bilateral proximal humerus fractures were evaluated retrospectively using the institution's database, with the focus on cause of the injury, fracture severity and the clinical course compared to published information on monolateral proximal humerus fractures. Bilateral posterior dislocation fractures were excluded, because these fractures are a separate entity. Results: Between 2005 and 2016, n = 17 patients were primarily treated within our hospital for an acute proximal humerus fracture on both sides (n = 12 female, n = 5 male, average age: 68 years; overall 34 proximal humerus fractures). The general trauma mechanism was a fall on both arms (82% [18% polytrauma]). There were 65% displaced 3-/4-part proximal humerus fractures. Angle-stable plate osteosynthesis was performed predominantly (64%), followed by fracture prosthesis (18%; tension wiring: 3%; non-operatively: 15%). Overall, n = 10 patients (59%) or n = 18 (53%) proximal humerus fractures developed a complication, primarily with loss of reduction or implant loosening (44%). In n = 14 (78%) of the complications further operations were necessary. Alcohol abuse was increasingly found in 29% of the cases within the bilateral patient cohort compared to patients with monolateral fractures. Conclusion: Bilateral proximal humerus fractures are mainly associated with comminuted displaced fractures and a higher complication rate in comparison to monolateral fractures after surgical treatment.
Article
Aim of the studyThe aim of this study was to evaluate union rate and clinical outcome in patients with proximal humeral nonunions treated by open reduction and locking plate fixation without bone grafting. Methods From 2011 to 2016, nine patients were treated using open reduction and locking plate stabilization without bone grafting. They were examined both clinically and radiologically, with a mean follow-up period of 31 months. Outcome was evaluated using pain and range of motion (ROM) parameters. In addition, self-assessment by patients was registered on the Disability of the Arm, Shoulder and Hand score, Constant-Murley Score, Oxford Shoulder Score, and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form. A CT scan of the shoulder was performed to analyze union. ResultsAt checkup, all patients showed union in the CT scans, where the mean ROM in abduction was 139° (SD 50°), in adduction 39° (SD 8°), in forward flexion 136° (SD 40°), in extension 44° (SD 11°), in internal rotation 62° (SD 15°), and external rotation 54° (SD 31°). ROM improved significantly in all planes of motion, except for adduction, post-surgery (p < 0.05). Plate removal was necessary in three patients. No complications were reported. Conclusion Open reduction and locking plate fixation without bone grafting is a reasonable and safe option for treating proximal humerus nonunion. It leads to a high union rate, significant improvement in ROM, and in the majority of the cases to an “excellent” and “good” functional outcome without an increased risk of complications.
Article
Objectives: This study sought to examine fatigue characteristics of two polyaxial locking screw designs: locking cap (LC) and cross-threaded (CT). The goal was to compare LC and CT implants at 0, 10, and 15 degrees of angulation to determine the effect of locking mechanism on screw-plate interface failure. The hypothesis was LC implants would have superior fatigue properties in comparison to CT designs and that increased angulation of the screw would have a negative impact on the fatigue life of CT implants, but would not have any effect on LC implants. Methods: A total of 72 screws were tested in four upper extremity implants. Implants were subjected to cyclic shear loads and subsequent ramp to failure. Performance characteristics were statistically compared using non-parametric statistical methods. Results: Fatigue testing demonstrated that LC designs were consistently able to sustain a significantly higher number of cyclic loads than CT designs. There were no significant differences in the number of cycles sustained by LC designs due to changes in screw angle, but CT implants exhibited decreases in screw stability with increasing angulation. Conclusions: Likely because of the spherical screw head geometry, LC fatigue characteristics are not influenced by the orientation of the screw relative to the plate. Application of a locking cap in the operating room requires additional time, but provides significantly more robust fixation of the screw, especially at oblique angles, to the plate and provides a more predictable and consistent biomechanical result.
Article
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Several methods have been devised to estimate shoulder function, none of which is entirely satisfactory. The method described in this article is applicable irrespective of the details of the diagnostic or radiologic abnormalities caused by disease or injury. The method records individual parameters and provides an overall clinical functional assessment. It is accurately reproducible by different observers and is sufficiently sensitive to reveal even small changes in function. The method is easy to perform and requires a minimal amount of time for evaluation of large population groups.
Article
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We have analysed the Constant-Murley (1987) assessment for 25 patients with shoulder pathology. We found the score easy to use, with low inter- and intraobserver errors, but sufficiently imprecise in repeated measurements to give concern in its use for clinical follow-up of patients. We have calculated 95% confidence limits for a single assessment to be within 16 to 20 points in most cases. In addition, we found that all our subjects with instability as their main problem scored within five points of the maximum; this suggests that the scoring method may need to be revised for use on these patients.
Article
Background: Successful internal fixation of fractures of the surgical neck of the humerus can be difficult to achieve because of osteopenia of the proximal aspect of the humerus. The purpose of this study was to compare the biomechanical stability of a proximal humeral intramedullary nail and a locking plate for the treatment of a comminuted two-part fracture of the surgical neck in a human cadaver model. Methods: Twenty-four cadaveric humeri were instrumented with use of either a titanium proximal humeral nail (PHN) or a 3.5-mm locking compression plate for the proximal part of the humerus (LCP-PH). The specimens were matched by bone mineral density and were separated into four experimental groups with six humeri in each: PHN bending, LCP-PH bending, PHN torsion, or LCP-PH torsion. Comminuted fractures of the surgical neck were simulated by excising a 10-mm wedge of bone. Bending specimens were cyclically loaded from 0 to 7.5 Nm of varus bending moment at the fracture site. Torsion specimens were cyclically loaded to ±2 Nm of axial torque. The mean and maximum displacement in bending, mean and maximum angular rotation in torsion, and stiffness of the bone-implant constructs were compared. Results: In bending, the LCP-PH group demonstrated significantly less mean displacement of the distal fragment than did the PHN group over 5000 cycles (p = 0.002). In torsion, the LCP-PH group demonstrated significantly less mean angular rotation than did the PHN group over 5000 cycles (p = 0.04). A significant number of specimens in the PHN group failed prior to reaching 5000 cycles (p = 0.04). The LCP-PH implant created a significantly stiffer bone-implant construct than did the PHN implant (p = 0.007). Conclusions: The LCP proximal humeral plate demonstrated superior biomechanical characteristics compared with the proximal humeral nail when tested cyclically in both cantilevered varus bending and torsion. The rate of early failure of the proximal humeral nail could reflect the high moment transmitted to the locking proximal screw-bone interface in this implant. Clinical Relevance: The high failure rate in torsion of the proximal humeral nail-bone construct is concerning, and, with relatively osteoporotic bone and early motion, the results could be poor.
Article
In the presented prospective study 35 consecutive patients with displaced 3- and 4-part fractures of the proximal humerus, including fracture dislocations, were treated with a fixator plate comprising angular stability between May 2001 and December 2002. After 18.5 (8-29) months 31 (89%) fractures were available for follow-up. Good and very good results were obtained in 64%. A poor result was documented in 23%. 64% of the patients had no or mild pain, 71% were able to abduct the arm over 90degrees. Fracture classification according to Neer and AO had no influence on the outcome, with a mean Constant Score of 76 points. Partial avascular necrosis (AVN) of the humeral head was seen in 16% of all cases representing 4% of the fractures without dislocation and 80% of the fracture dislocations. Fracture dislocation (p=0.02) and AVN(p=0.005) had a negative effect on the Constant Score, with AVN being a predictor for a high level of pain (p=0.04). Secondary dislocation of the greater tuberosity was seen in two patients, loosening of screws in one patient and a fracture below the plate in another one. Secondary dislocation or loss of reduction of the head was not recorded. Angle stable plate fixation with tension band wiring of the tuberosities is an effective and safe option to treat this difficult fractures, also in elderly patients with osteoporotic bone. Because 40% of the 4-part fractures with fracture dislocation yielded a satisfactory or better result, the plate fixator with angular stability may be an alternative to prosthetic replacement in selected cases.
Article
Background Proximal fracture of the humeral head is the third most frequent fracture in humans. Most (70%) of those affected are over 60 years old. It is hoped that advanced locking medullary screws or plates will reduce the risk of secondary dislocation of screws or fracture segments when the bone of the humeral head is osteoporotic. Methods From January 2002 to August 2005, 225 displaced humeral head fractures in 223 patients aged on average 66±15 years were treated with a new locking proximal humeral plate. Results In 176 patients in whom follow-up was possible, the average Constant Score after 9 months was 70±19 points (raw data), or 81±22% in the normalized score. No significant difference was detected between the younger group up to 65 years of age (73% points) and those over 65 years of age (80% points). Axial deviations by more than 30° were noted in 11 (5%), and of 159 displaced tubercles, malreduction by more than 5 mm was noted in 14 (9%). Two infections and two haematomas had to be treated so far. Primary screw perforations were seen in 24 (11%) cases as well as further implant dislocations in 3 (1,7%). Plate dislocations out of the shaft existed in 4 (2,4%) and 14 collapses of the humeral head with secondary screw perforations were recorded. All other complications arose out of technical faults, such as 24 screw perforations (11%) into the glenohumeral joint and 3 (1.7%) cases of secondary implant dislocation from the humeral head and 5 (3%) from the shaft, and 14 (8%) sinterings with glenohumeral screw perforation. So far, in addition to 1 case of pseudarthrosis with a broken plate, 5 (3%) cases of total and 9 (5%) of partial avascular humeral head necrosis have been observed. Conclusion The new implant provides superior stability in the fixation of humeral head fragments and has proved its worth in everyday clinical practice when additional indirect fixation of the tubercle is needed, as it frequently is in elderly patients.
Article
In einer prospektiven Studie wurden 35 konsekutive dislozierte 3- und 4-Fragmentfrakturen einschließlich der Luxationsfrakturen zwischen Mai 2001 und Dezember 2002 mit einer winkelstabilen Platte und zusätzlicher Fadenzuggurtung ohne Spongiosaplastik operativ versorgt. Nach durchschnittlich 18,5 Monaten (8–29) standen 31 (89%) Frakturen für die Nachuntersuchung zur Verfügung. In 64% aller Fälle konnten gute und sehr gute klinische Ergebnisse erreicht werden. In 23% wurden schlechte Ergebnisse festgestellt. 64% der Patienten hatten keine oder milde Schmerzen, 71% konnten den Arm über 90° abduzieren. Die Frakturklassifikation nach Neer und AO zeigte keinen Einfluss auf das klinische Ergebnis. Der Constant-Score lag durchschnittlich bei 76 Punkten. Radiologische Zeichen einer partiellen Humeruskopfnekrose (HKN) fanden sich bei 16% aller Fälle, mit 4% bei den nicht luxierten und 80% bei den luxierten Frakturen. Die Luxation der Kalotte (p=0,02) und die partielle HKN (p=0,005) hatten einen negativen Einfluss auf den Constant-Score, wobei die HKN negativ auf den Schmerzwert wirkte (p=0,04). Sekundäre isolierte Dislokationen der Tuberkula konnten bei 2 Patienten, Lockerung der Schrauben im Schaftbereich bei 1 Patienten und eine distale Fraktur bei einem weiteren Patienten beobachtet werden. Dislokationen oder Sinterungen der Kalotte hingegen wurden nicht beobachtet. Wir sehen die winkelstabile Plattenosteosynthese in Kombination mit der Zuggurtung der Tuberkula als sicheres und komplikationsarmes Verfahren, auch bei osteoporotischen Knochen. Da sogar bei den luxierten 4-Fragmentfrakturen mit erhaltener Kalottenkontur in 40% der Fälle befriedigende oder bessere Ergebnisse erreicht wurden, kann die winkelstabile Platte zu einem der Humeruskopfprothese ebenbürtigen klinischen Ergebnis führen.
Article
Die operative Therapie der Humeruskopffraktur wird kontrovers diskutiert. Ziel der vorliegenden Arbeit ist eine Evaluierung der eigenen Ergebnisse nach operativer Versorgung von proximalen Humerusfrakturen in Abhängigkeit des Osteosyntheseverfahrens und eine vergleichende Analyse mit den in der Literatur beschriebenen Ergebnisse. Wir erhoben retrospektiv die Daten von 51 Patienten (33 weiblich, 18 männlich, Durchschnittsalter 55 Jahre) nach durchschnittlich 4,2 Jahren. Das funktionelle Ergebnis wurde nach dem Constant-Score bewertet. 62,7 % unserer Patienten wurden mit einer T-Platte versorgt, 21,6 % minimalosteosynthetisch und 15,7 % prothetisch. Von den Patienten mit einer 3- und 4-Fragment-Faktur erreichten insgesamt 60,7 % ein sehr gutes oder gutes Ergebnis im Constant-Score. (59 % der Patienten mit T-Platte, 66 % der Patienten mit Minimalosteosynthese). Zur Ausbildung einer Humeruskopfnekrose kam es in 15,9 % der T-Plattenosteosynthesen und in 9,1 % der Minimalosteosynthesen. In dieser retrospektiven Untersuchung konnte trotz der prozentualen Unterschiede kein klinisch relevanter Vorteil eines Osteosyntheseverfahrens nachgewiesen werden. Bei der osteosynthetischen Versorgung der 4-Fragment-Frakturen scheint die Minimalosteosynthese Vorteile gegenüber der T-Plattenosteosynthese zu haben. Andererseits stellt die T-Plattenosteosynthese insbesondere bei jüngeren Patienten mit einer 2- und 3-Fragment-Fraktur auch heute noch ein adäquates Osteosyntheseverfahren dar.
Article
To determine the outcome after indirect reduction and buttress plate fixation of displaced and unstable proximal humeral fractures, we retrospectively evaluated 98 patients, an average of 34 months (range 24-72 months) after fracture fixation. The patients were reviewed and results were evaluated clinically according to the Neer, UCLA and Constant score. A radiographic evaluation of fracture healing, avascular necrosis and degenerative changes of the shoulder joint was performed in all patients. Any complications of treatment were assessed. Results were, according to the UCLA-rating system, good to excellent in 76% of fractures. According to the Constant-score and the Neer score, good to excellent results were obtained in 69 and 59% of fractures, respectively. Poor results were mainly due to secondary malunion. The avascular necrosis rate was 4%. Non-union was seen in one case. Secondary varus deformity and retroversion of the humeral head as a result of lack of rotational and angular stability of the plate developed in twelve (12%) and eight (8%) cases, respectively. Plate fixation is an adequate procedure for treating unstable and displaced two- to four-part fractures of the proximal humerus, enabling early functional after-treatment. The incidence of avascular necrosis and nonunion are low, when fracture reduction is performed indirectly. Poor rotational and angular instability can lead to a loss of reduction.