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Injury, Int. J.

Care Injured 45 (2014) 510514

Contents lists available at ScienceDirect

Injury
journal homepage: www.elsevier.com/locate/injury

A comprehensive update on current xation options for two-part


proximal humerus fractures
A biomechanical investigation
Richard S. Yoon a, Daniel Dziadosz b, David A. Porter b, Matthew A. Frank b, Wade R. Smith c,
Frank A. Liporace a,*
a
Division of Orthopaedic Trauma, Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, New York, NY 10003, USA
b
Division of Orthopaedic Trauma, Department of Orthopaedic Surgery, INOVA Fairfax Hospital, Faiefax, VA 22003, USA
c
Division of Orthopaedic Trauma, Department of Orthopaedic Surgery, Swedish Medical Center, Denver, CO 80204, USA

A R T I C L E I N F O A B S T R A C T

Article history: Background: Recent advancements in implant technology offer updated options for surgical manage-
Accepted 29 August 2013 ment that have been rapidly adopted into clinical practice. The objective of this study is to
biomechanically test and compare the current xation options available for surgical xation of two-part
Keywords: proximal humerus fractures and establish load to failure and stiffness values.
Proximal humerus fracture Methods: Sixteen match-paired (32 total) fresh-frozen, cadaveric specimens were randomized to receive
Intramedullary nail 1 of 4 xation constructs following creation of an AO/OTA Type 11A3 (two-part) proximal humerus
Fixed angle plate
fractures. Fixation constructs tested consisted of 3.5 mm xed angle plate (3.5-FAP), 4.5 mm xed angle
Locked plate
Fixed angle blade
plate (4.5-FAP), humeral intramedullary nail (IMN), and a humeral intramedullary nail with a xed angle
blade (IMN-FAB). Specimen bone density was measured to ensure no adequate, non-osteoporotic bone.
Constructs were tested for stiffness and ultimate load to failure and compared via one-way ANOVA
analysis with subsequent post hoc Tukey HSD multiple group comparison statistical analysis.
Results: The IMN-FAB construct was signicantly stiffer than the 3.5-FAP construct (123.8 vs. 23.9,
p < 0.0001), the 4.5-FAP construct (123.8 vs. 33.3, p < 0.0001) and the IMN construct (123.8 vs. 60.1,
p = 0.005). The IMN-FAB construct reported a signicantly higher load to failure than the 3.5-FAB
construct (4667.3 N vs. 1756.9 N, p < 0.0001), and the 4.5-FAP construct (4667.3 N vs. 2829.4 N,
p = 0.019, Table 2). The IMN construct had a signicantly higher load to failure than the 3.5-FAP
construct (3946.8 vs. 1756.9, p = 0.001, Table 2).
Conclusion: Biomechanical testing of modern xation options for two-part proximal humerus fracture
exhibited that the stiffest and highest load to failure construct was the IMN-FAB followed by the IMN,
3.5-FAP and then the 4.5-FAP constructs. However, prospective clinical trials with longer-term follow-up
are required for denitive assessment of the ideal xation construct for surgical management of two-
part proximal humerus fractures.
2013 Elsevier Ltd. All rights reserved.

Introduction population of North America and Western Europe, these fractures


are increasing in incidence. Dening optimal treatment
Proximal humerus fractures account for nearly 5% of all approaches is an important public health care issue as well as a
fractures, with increasing incidence during the later decades of specic concern for the quality of life of affected patients and
life.1,2 Ideal treatments to maximize outcomes remain controver- treating surgeons.
sial; in regards to surgical intervention, despite the evolution of Nearly two decades ago, Koval et al. performed a biomechanical
implants, absolute surgical indications leading reproducible out- study comparing the ten most common xation methods available
comes are still lacking concensus.1,3,4 However, given the ageing for proximal humerus fractures at that time.5 Classically, this
biomechanical study was a true test of the xation constructs as it
focused on a shear load-to-failure and stiffness comparison in non-
osteoporotic cadaver models. This protocol has rarely been
* Corresponding author at: Department of Orthopaedic Surgery, NYU Hospital for
Joint Diseases, 301 E 17th Street, Suite 1402, New York, NY 10003, USA.
repeated in more recent studies.612
Tel.: +1 201 309 2426; fax: +1 212 598 7654. Since Kovals original article, several new xation methods for
E-mail address: liporace33@gmail.com (F.A. Liporace). proximal humerus fractures have been introduced.612 With a

00201383/$ see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.injury.2013.08.024
R.S. Yoon et al. / Injury, Int. J. Care Injured 45 (2014) 510514 511

primary focus on xed angle devices, locking technology and surgical neck of the proximal humerus using a reciprocating saw.
intramedullary nailing, many of the more recent biomechanical The fracture line was made at a 10-degree oblique angle directed in
studies have tested cyclic loading parameters, torsional resistance a medial and inferior direction based on the model proposed by
and bending, but few have reported on axial load to failure or Koval.5 In addition, a 1 cm medially based wedge of cortex at the
stiffness.79,1326 Furthermore, while many have tested these fracture site was removed to simulate a comminuted fracture
constructs in a head-to-head fashion, few studies have looked at pattern as per Chudnik, ultimately creating an unstable, AO/OTA
comparing these modern constructs in the same study.9,15 Type 11A3 proximal humerus fracture.7 Dual-energy X-ray
Traditional implant testing in the axial load-to-failure type or absorption scans of the proximal humerus were obtained to
catastrophic failure provides valuable information regarding quantify bone quality in terms of T-scores. Additionally, all
implant safety. Specically, concerning the more current xation specimens were radiographed to identify any lesions that might
methods, incremental load to failure in a 208 abduction angle to affect osseous integrity, of which there were none.
simulate maximal axial and shear load has not been performed.
This is a critical test that closely parallels the physiologic loads Fixation constructs
placed upon implants during routine post operative rehabilitation.
The objective of our study was to apply the standardized All specimens were xed according to industry/implant
techniques as described by Koval to current xation techniques. protocols. Four different constructs were created with the
Our study goal was to compare xed angle plates and intrame- aforementioned implants for a total of eight specimens per
dullary nail constructs to determine which construct has the implant. The matched pairs were randomized using a Monte Carlo
highest stiffness and ultimate load to failure when placed in the ordered randomization method with an equal side-to-side
maximum shearing load position, simulating a catastrophic load to distribution among all implants.27 Once nal instrumentation
failure scenario in an angle seen during early active range of and osteotomies were created, all specimens orthogonal radio-
motion.5 These ndings can provide the biomechanical equipoise graphic evaluation to ensure appropriate hardware position
to initiate randomized clinical studies to determine best practice (Fig. 1AD).
for these common yet vexing injuries.
Test setup
Materials and methods
The distal one-third of each specimen was removed and then
In a biomechanical study, one of four methods of fracture each construct was mounted in a polymethyl-methacrylate
xation: 3.5 mm locked xed angle plates (3.5-FAP), 4.5 mm (PMMA) at a 20-degree abduction angle. This angle simulates
locked xed angle plates (4.5-FAP), proximal humerus intrame- maximal axial and shear load to the humerus at a motion
dullary nails with locked and screws (IMN), and intramedullary analogous to the load seen in early active abduction.28,29 These
nails with xed angle blades (IMN-FAB), was applied to 16 were then mounted in an Instron materials testing simulator
matched pairs of cadaveric proximal humerii. Each specimen was (Instron Inc., Norwood, Massachusetts, USA, Fig. 2). The load was
then incrementally loaded to failure at a rate of 10 cm/min. Failure focused one cm lateral to the articular margin, as per the previously
was dened as a marked decrease or discontinuity in the load dened protocol.7 A load rate of 10 cm/min was then applied to the
displacement curve. construct until failure (dened by a marked decrease or
discontinuity in the load displacement curve).5,7 The mode of
Specimens each constructs failure was determined by inspection. Average
values for displacement and maximum load to failure were
Sixteen matched paired (32 total) cadaveric proximal humerii measured during testing and average stiffness for each of the four
were prepared for use with all soft tissue stripped from the constructs was calculated. One-way analysis of variance (ANOVA)
specimens. Once prepared, a simulated fracture was made at the tests were performed comparing both stiffness and ultimate load

Fig. 1. (AD) Radiographic images of (A) 3.5 mm locking plate construct, (B) 4.5 mm locking plate construct, (C) intramedullary nail with locking screws and (D)
intramedullary nail with a xed angle blade.
512 R.S. Yoon et al. / Injury, Int. J. Care Injured 45 (2014) 510514

Fig. 3. Mean stiffness ranges for the four tested biomechanical constructs. One-way
ANOVA indicated statistically signicant differences across all four groups
(p < 0.0001).

Similarly, in descending order, the construct that required the


most force to fail was the IMN-FAB group (4667.3  1157.3 N)
followed by the IMN group (3946.8  1539.9 N), the 4.5-FAP group
(2829.4  1452.3 N), and the 3.5-FAP group (1756.9  609.0 N); one-
way ANOVA analysis also noted statistically signicant differences
Fig. 2. Mounted specimen in the MTS machine, at a 208 abduction angle to maximize amongst the four group means (Table 1 and Fig. 4, p < 0.0001).
shear axial load forces.
More specic construct comparisons, statistically analyzed via
Tukey HSD post hoc analysis following the initial one-way ANOVA,
to failure between all four groups; Tukey HSD post hoc analysis for reported several signicant differences between the constructs in
multiple mean comparisons across all four groups was also both stiffness and load to failure comparisons (Table 2). The IMN-
performed. Signicant was set at p < 0.05. FAB construct was signicantly stiffer than the 3.5-FAP construct
(123.8 vs. 23.9, p < 0.0001), the 4.5-FAP construct (123.8 vs. 33.3,
Results p < 0.0001) and the IMN construct (123.8 vs. 60.1, p = 0.005,
Table 2). No signicant differences were found when comparing
Bone quality did not differ signicantly among the specimens mean stiffness between the 3.5-FAP and 4.5 FAP constructs (23.9
(T-score = 1.3  1.8) and none of the T-scores were greater than one vs. 33.3, p = 0.95), the 3.5-FAP and IMN constructs (23.9 vs. 60.1,
standard deviation of the mean; therefore none of the specimens p = 0.15) or the 4.5-FAP and IMN constructs (33.3 vs. 60.1, p = 0.46,
were osteoporotic, but osteopenic, mimicking a hybrid between the Table 2).
representative bimodal distribution of patients suffering from such Head-to-head load to failure comparisons also yielded signi-
an injury that undergoes surgical xation. Achieving this goal of bone cant differences between the constructs (Table 2). The IMN-FAB
density allowed to test what surgeons can truly control, implant construct reported a signicantly higher load to failure than the
selection. 3.5-FAB construct (4667.3 N vs. 1756.9 N, p < 0.0001), and the 4.5-
In descending order, the stiffest construct was the IMN-FAB FAP construct (4667.3 N vs. 2829.4 N, p = 0.019, Table 2). The IMN
group (123.8  50.0 N/mm) followed by the IMN group construct had a signicantly higher load to failure than the 3.5-FAP
(60.1  51.0 N/mm), the 4.5-FAP group (33.3  23.1 N/mm), and construct (3946.8 vs. 1756.9, p = 0.001, Table 2). No signicant
the 3.5-FAP group (23.9  15.1); one-way ANOVA analysis yielded differences between ultimate load to failure was found between
statistically signicant differences across the four groups (Table 1 and
Fig. 3, p < 0.0001).

Table 1
Mean stiffness and load to failure measurements with 95% condence interval
ranges.

Mean (SD) 95% CI range (lowerupper)

Stiffness*
3.5-FAP 23.9 (15.1) 13.834.1
4.5-FAP 33.3 (23.1) 13.952.6
IMN 60.1 (51.0) 23.696.6
IMN-FAB 123.8 (50.0) 85.4162.2

Load to failure*
3.5-FAP 1756.9 (609.0) 1347.72166.0
4.5-FAP 2829.4 (1452.3) 1615.24043.5
IMN 3946.8 (1539.9) 2845.35048.4
IMN-FAB 4667.3 (1157.3) 3777.85556.9
* Fig. 4. Mean load to failure measurements for the four biomechanical constructs.
One-way ANOVA analysis yielded statistically signicant differences across all
four groups, p < 0.0001. Please see Table 2 for more detailed group comparisons via One-way ANOVA analysis yielded statistically signicant difference across all four
Tukey HSD post hoc analysis. groups (p < 0.0001).
R.S. Yoon et al. / Injury, Int. J. Care Injured 45 (2014) 510514 513

Table 2
Head-to-head stiffness and load to failure comparisons between constructs. Statistical analysis via Tukey HSD was performed post hoc, after establishing signicance via one-
way ANOVA.

Construct 1 Mean (N/mm) Construct 2 Mean (N/mm) Absolute mean difference p Value

Stiffness comparisons
3.5-FAP 23.9 4.5-FAP 33.3 9.4 0.95
3.5-FAP 23.9 IMN 60.1 36.2 0.15
3.5-FAP 23.9 IMN-FAB 123.8 99.9 <0.0001
4.5-FAP 33.3 IMN 60.1 26.8 0.46
4.5-FAP 33.3 IMN-FAB 123.8 90.5 <0.0001
IMN 60.1 IMN-FAB 123.8 63.7 0.005

Load to failure comparisons


3.5-FAP 1756.9 4.5-FAP 2829.4 1072.5 0.25
3.5-FAP 1756.9 IMN 3946.8 2190 0.001
3.5-FAP 1756.9 IMN-FAB 4667.3 2910.5 <0.0001
4.5-FAP 2829.4 IMN 3946.8 1117.5 0.234
4.5-FAP 2829.4 IMN-FAB 4667.3 1838 0.019
IMN 3946.8 IMN-FAB 4667.3 720.5 0.58

the 3.5-FAP and 4.5-FAP constructs (1756.9 vs. 2829.4, p = 0.25), the implants within osteopenic bone, achieving a hybrid between
the 4.5-FAP and IMN groups (2829.4 vs. 1117.5, p = 0.234), or the the bimodal distribution of patients representative of receiving
IMN and IMN-FAB constructs (3946.8 vs. 4667.3, p = 0.58, Table 2). surgical xation. Given the anatomy of these fractures and the
Observation of the construct failures revealed that each failed in common failure modes, having implants that are too stiff is an
a similar fashion. The intramedullary devices failed with the unlikely and possibly unachievable situation. Therefore, stiffer
proximal head xation remaining in place and failure was noted in implants that can be placed with minimal intrusion and damage to
the shaft, with all ten specimens sustaining shaft fractures. the local blood supply are likely to have lower failure rates.
Similarly, the plate failures occurred with shaft cut out and not Previous biomechanical studies have focused primarily on
head cut out. cyclic loading, bending, torsion and other testing modalities, but
have left out the baseline stiffness and axial load data reported in
Discussion our study.79,15,17,18,2022,25,34,35 Edwards et al. in an effort to
compare a proximal humeral nail to a 3.5 mm locking plate
Treatment of unstable proximal humerus fractures can pose a construct similarly found biomechanical superiority with the nail.
challenge to the treating physician. With an inability to maintain a However, their study was performed with a cyclical loading
satisfactory reduction by closed means, operative intervention construct and did not report on pure axial load to failure.8 We did
provides the best option to maintain an adequate reduction.2 The test to axial load to failure as this is a critical component of failure
proximal portion of the humerus undergoes multiple forces in the in vivo patient given the deforming forces of the rotator cuff
through any given range of motion and xation of these fractures and deltoid muscles. Similarly, other authors have tested various
needs to be able to withstand these forces. The implants tested can nail and plate constructs, but did not report baseline axial load and
all withstand the rigours of motion and can maintain anatomic stiffness values despite measuring more complex, multiplanar
length and alignment, but in this study it was determined that the shoulder forces.9,17,18 We feel, given the practical and predictable
proximal humeral nail with xed angle blade is biomechanically nature of failure in these patients, that stiffness and axial load to
more stable to varus collapse than the other implants tested failure are critical characteristics that need to be described and
exhibiting the highest stiffness and axial load to failure in a compared between implants, particularly given the relatively high
position of maximum shear. clinical failure rates reported in the literature.31,36
All implants have advantages and disadvantages. Fixation with The primary limitation of our study is that there is no
an intramedullary device prevents the soft tissue stripping that is standardized testing protocol for the proximal humerus. Multiple
required for xation with a proximal humeral plate. Additonally, models have been proposed to mimic the complex range of motion
precise plate/screw placement is required to achieve and maintain of the shoulder joint. Consequently, basic biomechanical tests are
reduction, which can increase operative time and blood loss.30 often not performed. Without a consensus about how best to
However, intramedullary nail insertion does require dissection examine in vitro, the forces affecting a shoulder injury researchers
through the rotator cuff tendons and has been noted to have an must make basic assumptions about what testing studies are most
increased incidence of shoulder pain.8 Both techniques are useful relevant to a particular injury to the shoulder girdle. Given the
with documented positive outcomes. When failure does occur, the most common modes of failure following xation of proximal
mode is most often varus collapse.31 Therefore, determining which humerus fractures, we chose biomechanically basic parameters:
implants have the highest resistance to varus collapse is an axial load to failure and stiffness. More complex motions such as
important factor in implant selection. torsion, shear and circumduction may be part of the stresses on
Implant stiffness however is not always the most valued these fractures and therefore our model of testing may not
parameter in regards to implant xation. Observational documen- accurately mimic all the forces affecting outcome in the in vivo
tation over the years has shown that excessively stiff implants can situation. We would point out however, that few patients in the
decrease micromotion, subsequent callus formation and lead to true clinical situation move their shoulder in a normal manner and
delayed or non-unions in many fracture types.32,33 The optimal that failure usually occurs relatively early before complex
degree or parameter of stiffness for fracture healing is not know. movement has been initiated. Our study results therefore provide
We do know that proximal humerus fractures have short, important baseline information on modern implants that is
osteoporotic metaphyseal fracture segments, which permit a previously lacking in the literature. The clinical relevance of our
limited amount of xation that must be stiff enough to permit bone ndings is that despite the current trend towards anatomically
healing while preventing failure. With this reason, we chose to test specic locking plates for proximal humerus fracture xation, xed
514 R.S. Yoon et al. / Injury, Int. J. Care Injured 45 (2014) 510514

angle intramedullary nails may be a better alternative. Further- 15. Fuchtmeier B, May R, Hente R, et al. Proximal humerus fractures: a comparative
biomechanical analysis of intra and extramedullary implants. Arch Orthop
more, an important note is allowing for an increased working Trauma Surg 2007;127(6):4417.
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in load to failure, albeit a decrease in stiffness. This is a parameter part proximal humerus fractures: a cadaveric study. Orthopedics 2009;32(11):
816.
that should have been studied in depth. 17. Horn J, Gueorguiev B, Brianza S, Steen H, Schwieger K. Biomechanical evaluation
In conclusion, intramedullary nail devices provided more of two-part surgical neck fractures of the humerus xed by an angular stable
stability and stiffness, compared to locking plates in an axial load locked intramedullary nail. J Orthop Trauma 2011;25(7):40613.
18. Huff LR, Taylor PA, Jani J, Owen JR, Wayne JS, Boardman ND. 3rd. Proximal
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with previous reported clinical series provide the equipoise for a tion with an intramedullary bular allograft. Clin Biomech (Bristol Avon)
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Conict of interest 22. Rothstock S, Plecko M, Kloub M, Schiuma D, Windolf M, Gueorguiev B. Bio-
mechanical evaluation of two intramedullary nailing techniques with different
The authors have no direct conict of interest to report. locking options in a three-part fracture proximal humerus model. Clin Biomech
(Bristol Avon) 2012;27(7):68691.
23. Siffri PC, Peindl RD, Coley ER, Norton J, Connor PM, Kellam JF. Biomechanical
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