Operative Versus Non Operative Treatment For Two Part Surgical Neck Fractures of The Proximal Humerus
Operative Versus Non Operative Treatment For Two Part Surgical Neck Fractures of The Proximal Humerus
Operative Versus Non Operative Treatment For Two Part Surgical Neck Fractures of The Proximal Humerus
DOI 10.1007/s00402-013-1798-2
Trauma Surgery
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Arch Orthop Trauma Surg
~66/10,000 [13]. Associated with osteoporosis, proximal i.e. all patients were treated conservatively in the “conserv-
humerus fractures rarely affect patients under 60 years of ative” centre and all patients were treated operatively using
age and reduced bone quality poses significant challenges the assigned implant in the various “operative” centres.
for treatment of these injuries [18, 20]. Operative therapy All patients with two-part fractures of the surgical neck
is prone to inherent and partially unsolved problems and (i.e. A2 and A3 type fractures according to AO classifica-
has been shown to be associated with markedly high com- tion) included in the underlying cohort study were iden-
plication rates [18]. Conservative treatment has proved a tified and taken for this post hoc analysis. Exclusion cri-
safe treatment option associated with reasonable functional teria included pseudarthrosis, pathological fractures and
outcome for fractures of the proximal humerus of differ- refractures, open fractures or concomitant fractures of the
ent complexity [5, 6, 8, 22, 23]. Owing to the good results ipsilateral elbow or distal radius. In addition, patients with
of conservative treatment, operative treatment for two-part existing disorders having a relevant effect on the healing
fractures of the proximal humerus has been questioned process and function such as multiple sclerosis, paraplegia
by some authors [6, 8]. However, the most relevant study or other relevant neurological disorders, polytraumatized
[6] comparing operative to conservative treatment of this patients with an Injury Severity Score (ISS) exceeding 16
entity had several flaws, namely a small number of opera- or patients with pre-existing plexus injury or nerve palsy
tively treated patients and high rates of incomplete reduc- were excluded.
tion. Moreover, flexible nailing and tension band wiring, Eight and 70 surgeons were involved in the non-opera-
techniques that have more and more been abandoned in the tive and operative groups, respectively. Treating surgeons
presence of modern fixation devices, were used for stabili- were fellowship-trained trauma surgeons and had to have
sation in all cases. performed at least 30 proximal humerus fracture stabilisa-
Fostered by advancements in implant design, namely the tion procedures and 5 with the respective Synthes implant
introduction of locked plates and intramedullary nails with used in the study. All operative procedures were performed
spiral blades (angular stable proximal fixation) promising using standard approaches (i.e. delta-split approach for
enhanced stability even in osteopenic cancellous bone and PHN and anterior deltoideo-pectoral approach for LPHP
in presence of severe comminution operative treatment has and PHILOS) and AO reduction techniques and implants
more recently been advocated by various authors, particu- were used according to manufacturer’s recommendations.
larly for more displaced fractures and in younger patients Postoperatively, the arm was immobilised in a sling and
[1, 9, 11, 19]. The aim of the present analysis was there- passive ROM exercises were started within 2 days after
fore to compare the outcomes of non-operatively treated surgery. Controlled active mobilisation with abduction and
patients with two-part fractures of the proximal humerus to flexion beyond 90° was started 1–3 weeks postoperatively,
those treated operatively using modern implants (intramed- depending on the stability of the osteosynthesis and bone
ullary nails and locking plates). quality.
Conservative treatment included immobilisation of the
shoulder in an arm sling for 1–3 weeks with passive ROM
Materials and methods exercises starting after 1 week. Controlled active mobi-
lisation was allowed after 4 weeks. Initial closed reduc-
Patient inclusion and treatment tion manoeuvres were allowed at discretion of the treating
physician.
Data used in this analysis have been collected prospec-
tively in the context of a large cohort study that was per- Data collection
formed as a series of four separate case series (i.e. treat-
ment arms, with similar protocols and case report forms). During hospitalisation, patient demographics (i.e. gender,
There was one non-operative group, which was exclusively age, dexterity, smoking, concomitant diseases, and medi-
enrolled in one centre [8], and three operative groups [2, cation) and baseline characteristics (i.e. date of accident,
3, 21] using three different standard AO implants (Synthes, accident type, energy level of trauma, concomitant inju-
Solothurn, Switzerland) in 27 other level I trauma centres, ries, fracture classification, date of surgery, operation time,
whereby each centre used only one, i.e. the locking proxi- c-arm counter time, additional implants and sutures, addi-
mal humerus plate (LPHP), the proximal humerus inter- tional medication, type and duration of immobilisation,
nal locking system (PHILOS) or the proximal humerus and beginning of active assisted and unrestricted mobili-
nail (PHN). The study was designed in a way that within sation) were recorded. Fractures were classified according
the study period all patients who met the inclusion crite- to the AO-Müeller classification [14] by the treating sur-
ria were treated with the treatment option assigned to the geon using plain radiographs and intraoperative fracture
respective centre, irrespective of displacement or stability, visualisation.
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Arch Orthop Trauma Surg
Scheduled follow-up visits were performed 3, 6 and examination, occurrence of local complications within
12 months following injury. At each follow-up visit, the 1 year) were analysed by multivariable binomial regres-
patients were examined and interviewed concerning their sion, and adjusted risk ratios (RR) were used to quantify
pain, shoulder mobility and strength and the Constant treatment effect.
scores [4] of the injured and the contralateral shoulder were We made a post hoc power analysis using repeated
obtained. Isometric muscle strength was assessed using a measures ANOVA and the Constant and Murley score.
Nottingham Mecmesin Myometer (Mecmesin Co, Not- Group sizes of 26 and 103 patients, respectively (i.e. as
tingham, UK). The tests were performed with the shoul- examined at 1-year follow-up), provided >99 % power to
der at 90° abduction, or, if 90° could not be reached, in detect a minimum difference of 10 points in the Constant
maximum active abduction as described by Constant [4]. and Murley score with a known standard deviation of 13;
Patients were asked to maintain this resisted abduction the correlations between contralateral and injured sides,
for 5 s. The mean of three tests was recorded as strength and between follow-ups were set to 0.50 and 0.80, respec-
of the shoulder. Patients with a history of trauma or prior tively. For achieving a power of 90 %, 14 and 61 patients in
surgery involving the contralateral shoulder were not taken both groups would have been required.
into consideration for the contralateral Constant scores at
follow-up visits. At the 12-month follow-up visit we addi-
tionally obtained Neer scores [15] for each patient. Results
True AP and trans-scapular Y view radiographs were
obtained postoperatively (in case of operative treatment) This analysis included 31 patients (one clinic) with two-
and subsequently at each follow-up visit. The treating sur- part fracture in the non-operative and 133 patients (21 clin-
geon evaluated the radiographs primarily for fracture heal- ics) in the operative group. Final 1-year follow-up data
ing and possible occurrence of complications. All radio- were available from 26 to 103 patients (84 and 77 %) in
graphs and collected clinical data were jointly reviewed non-operative and operative groups, respectively. Both
by two of the authors to validate complication records and groups were comparable with regard to all demographic
define their most likely influencing factors, as well as docu- parameters assessed (Table 1); analyses, however, were
ment final deformity (valgus/varus deviation) at the fracture adjusted for age, presence of comorbidities, energy level of
site. injury, dominant arm injured and fracture type to control
for a potential confounding effect.
Data management and statistics There was a continuous and highly significant improve-
ment over time for all outcome parameters (pain, range of
Study monitoring, database management and statistics were motion, absolute and relative Constant scores) assessed in
carried out at a central monitoring organisation. Patients patients from both non-operative and operative treatment
who had undergone conservative treatment were compared groups (P < 0.001).
to those operatively treated regarding baseline demograph-
ics and injury parameters using standard descriptive sta-
tistics and non-parametric univariable tests. Observed dif-
Table 1 Patient demographics
ferences between the groups were considered carefully by
clinical judgement; variables with differences potentially Parameter Operative Non-operative P value
confounding the outcome comparisons were considered for
N 133 31
adjustment in multivariable analyses.
Mean age (SD) (years) 62.9 (17.2) 65.6 (13.3) 0.479a
Treatment groups were compared regarding shoulder
Gender (male/female) 36/97 9/22 0.826b
function and health status at 3, 6, and 12 months. For each
Dexterity (%) 92 87 0.413b
continuous outcome, any repeated measurements of each
Comorbidities (%) 47 65 0.110b
patient were pooled and analysed together in one overall
Energy (high/low) 27/106 2/29 0.113b
multivariable linear regression model. The likelihood ratio
Dominant arm injured (%) 39 29 0.409b
test was used to test the null hypothesis that there would
Injured side (right/left) 47/86 13/18 0.537b
be no difference in shoulder function and health status
between the two groups. The analyses of absolute Con- Worked before accident (%) 28 29 1.000b
stant score and range of motion values were adjusted for AO Classification [N (%)] 0.207b
respective contralateral healthy side values, as appropriate. A2 47 (35) 7 (23)
For each patient the mean of contralateral values recorded A3 86 (65) 24 (77)
a
across follow-up examinations was used as reference value. Wilcoxon rank-sum test
Four dichotomous parameters (pain at each follow-up b
Fisher’s exact test
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Arch Orthop Trauma Surg
Neer score
12 27/103 (26 %) 6/26 (23 %) 1.28 (0.59; 2.76) 0.984 60 Failure
Table 3 Absolute and relative Parameter Follow-up Operative Non-operative Group difference (95 % P valueb
Constant scores (months) CI)a
Absolute and relative (% of
healthy side) Constant scores at Healthy sidec – 82.8 (7.5) 82.1 (5.6)
follow-up visits [mean (SD)] Absolute injured side 3 57.5 (14.1) 51.2 (15.2) 3.0 (−2.2; 8.1) 0.257
a
95 % confidence interval 6 65.8 (14.7) 67.3 (13.2) −3.1 (−8.2; 2.0) 0.237
b
Wald test 12 74.2 (13.0) 74.3 (9.9) −1.7 (−6.9; 3.5) 0.528
c
For each patient, the mean of % of healthy side 3 69.1 (16.6) 62.2 (18.1) 4.0 (−2.2; 10.2) 0.202
contralateral values recorded 6 79.0 (15.9) 81.7 (14.6) −3.1 (−8.2; 2.0) 0.529
across follow-up examinations 12 88.9 (12.8) 90.8 (9.6) −1.7 (−6.9; 3.5) 0.494
was used as reference value
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Arch Orthop Trauma Surg
Table 4 Range of motion Direction Follow-up Operative Non-operative Group difference P valueb
(months) (95 % CI)a
Flexion
Healthy side (°)c – 165.7 (17.1) 169.9 (13.5)
Absolute injured 3 111.9 (34.3) 112.9 (31.9) −3.4 (−15.5; 8.8) 0.585
side (°) 6 132.4 (31.6) 133.2 (33.8) 0.1 (−12.3; 12.5) 0.989
12 145.0 (32.7) 136.2 (37.8) 10.2 (−2.4; 22.8) 0.114
% of healthy side 3 67.2 (20.0) 66.8 (18.2) −1.9 (−9.2; 5.5) 0.621
6 80.1 (17.8) 78.7 (18.7) 0.6 (−6.9; 8.1) 0.872
12 87.8 (17.9) 80.4 (19.4) 7.1 (−0.5; 14.8) 0.069
Abduction
Healthy side (°)c – 156.2 (27.7) 166.6 (17.7)
Absolute injured 3 96.9 (37.0) 101.2 (37.6) −3.6 (−17.0; 9.8) 0.601
side (°) 6 118.7 (37.7) 125.2 (39.4) −0.6 (−14.2; 13.1) 0.934
Absolute and relative (% of 12 131.9 (38.0) 131.2 (35.2) 7.4 (−6.4; 21.3) 0.294
healthy side) ranges of motion % of healthy side 3 62.9 (22.4) 60.8 (21.5) −1.1 (−9.4; 7.3) 0.798
for flexion, abduction and 6 77.3 (22.1) 75.3 (20.7) 1.9 (−6.6; 10.4) 0.656
passive external rotation at
follow-up examination 12 85.3 (19.5) 79.1 (16.8) 6.7 (−1.9; 15.4) 0.126
Group difference of operative Passive external rotation
over non-operative treatment Healthy side (°)c – 66.8 (16.9) 58.5 (14.0)
* Significant at 0.05 level Absolute injured 3 42.3 (23.7) 47.8 (23.1) −12.8 (−20.1; −5.4) 0.001*
a
95 % confidence interval side (°) 6 51.0 (22.2) 47.0 (23.5) −3.2 (−10.7; 4.4) 0.411
b
Wald test 12 58.9 (21.2) 42.3 (16.6) 8.6 (0.8; 16.3) 0.031*
c
For each patient the mean of % of healthy side 3 61.6 (30.1) 80.5 (35.0) −20.3 (−31.8; −8.9) 0.001*
contralateral values recorded 6 75.0 (24.9) 79.3 (32.5) −4.3 (−16.0; 7.4) 0.470
across follow-up examinations 12 86.4 (25.9) 74.2 (26.0) 13.1 (1.1; 25.2) 0.033*
was used as reference value
0
° ° ° ° 15°
Discussion
>45 -4 5 -30 / -15 s>
rus > 30° > 15° al + lgu
Va ru s ru s mic Va
Va Va ato
An
The aim of this analysis was to compare the outcomes of
Varus/Valgus deviation categories operative to non-operative treatment strategies in patients
Non-operative Operative with isolated two-part surgical neck fractures of the proxi-
mal humerus. The most important finding of the present
Fig. 2 Coronal plane alignment as assessed on plain radiographs at analysis was that both operatively and non-operatively
1-year follow-up. Binomial regression analysis revealed a significant treated patients can expect reasonable shoulder function
reduction of varus malalignment exceeding 15° in the operative group
and, if any, superiority of operative over non-operative
(RR = 0.70; 95 % CI 0.47; 1.05, P = 0.083)
treatment can only be expected in the first 3 months follow-
ing injury.
Complications are summarised in Table 5. All but one Appreciation for the strengths and limitations of the
operated fractures showed bony union at 12-month fol- present study is warranted. First and foremost patients
low-up, there was one case of avascular necrosis and one were not randomly assigned to either one of the treatment
deep infection in the operative group. Generally, there groups; the choice of therapy was left at discretion of the
was a non-significant tendency towards a higher compli- treating physician and lastly of the patient. Therefore,
cation rate in surgically treated patients (RR = 4.9; 95 % some selection bias cannot be excluded. Randomisation
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Arch Orthop Trauma Surg
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Arch Orthop Trauma Surg
non-operative treatment at the 3 month follow-up. It is rea- of operatively treated patients. One possible explanation
sonable to conceive that a higher initial stability translating might be a higher rate of implant-associated complications
to pain reduction and allowing for more aggressive physi- (such as plate impingement or implant failure) in cases
otherapy in the early course of treatment may account for with excessive varus malalignment. In fact, implant related
this observation. complications were significantly more frequent in cases
Expectedly, radiographic analyses revealed a significant of excessive varus malalignment. The causality, however,
reduction of coronal plane malalignment in the operative remains unclear. One could argue that such complications
group. The improvement of alignment observed in the oper- lead to a loss of reduction and therefore resulted in mala-
ative group did, however (at least for two-part fractures), lignment. Secondary dislocation can certainly account for
not translate to better overall outcomes. Interestingly, some of the malalignments. Dislocation rates were, how-
varus malalignment exceeding 15° was associated with an ever, not high enough to explain for all the malalignments
impairment of Constant scores in the operative group. On observed. They may more likely be the result of insufficient
the contrary, varus malalignment did not have a significant reduction at time of surgery. We therefore hypothesise that
effect on Constant scoring in the non-operative group– increased implant-associated complications may be a con-
–an observation that is in accordance with that of Court- sequence of insufficient restoration of alignment (i.e. insuf-
Brown et al. [6] who found no correlation of outcome and ficient reduction).
alignment. We can only speculate why varus malalign- Non-union is rarely considered a problem in two-part
ment seems to have a detrimental effect on the outcome fractures of the proximal humerus and rates of <5 % have
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Arch Orthop Trauma Surg
been reported [6]. Accordingly, only one case of non-union (C. Sinopidis); Johannes Gutenberg Universitätsklinikum, Klinik
was observed in the present series. In accordance with für Unfallchirurgie, Mainz, Germany (J. Blum); Università di
Padova, Ortopedia e Traumatologia, Padova, Italy (A. Olmeda);
previous reports on operative stabilisation of proximal Vogtlandklinikum Plauen, Plauen, Germany (W. Merbold); Kardi-
humerus fractures, most of the complications were implant nal Schwarzenberg’schen Krankenhaus, Abteilung für Unfallchirur-
failures (particularly primary and secondary screw perfora- gie, Schwarzach, Austria (F. Genelin); Unfallkrankenhaus Meidling,
tion and loss of reduction) and could partially be attributed Wien, Austria (H. Matuschka); Klinikum Worms gGmbH, Worms,
Germany (J. Blum) PHILOS: Rätisches Kantons- und Regionalspi-
to an insufficient operative procedure. tal, Chur, Switzerland (C. Sommer); Hôpital Cantonal de Fribourg,
Infections are uncommon affecting ~1 % of all opera- Fribourg, Switzerland (G. Kohut); Westpfalz-Klinikum GmbH,
tively treated patients. Accordingly, there was only one Unfallchirurgie Klinik, Kaiserslautern, Germany (H. Winkler); Kan-
case of deep infection in the present series. The overall tonsspital Luzern, Chirurgie/Traumatologie, Luzern, Switzerland (R.
Babst); Klinikum Rosenheim, Unfall- und Wiederherstellungschi-
complication rates were low as compared to other studies rurgie, Rosenheim, Germany (G. Regel); BG Unfall- und Univer-
on operative treatment of proximal humerus fractures [12, sitätsklinik, Tübingen, Germany (D. Höntzsch) LPHP: Charité Uni-
18–20]. This can, however, almost certainly be attributed to versitätsmedizin Berlin, Zentrum für Muskuloskeletale Chirurgie,
the fact that only two-part fractures were included in the Berlin, Germany (N. Haas); Allgemeines Krankenhaus Celle, Celle,
Germany (H-J. Oestern); Albert-Ludwigs-Universität, Orthopädie und
present analysis which are notoriously less frequently asso- Traumatologie, Freiburg, Germany (N. Südkamp); Universitätsklinik
ciated with complications when compared with three- and für Unfallchirurgie Graz, Graz, Austria (M. Plecko); Evangelisches
four-part fractures or fracture dislocations of the proximal Diakoniewerk Friederikenstift, Unfallklinik, Hannover, Germany (H.
humerus. In summary, with regard to the present analyses Lill); Universität Leipzig, Klinik für Unfall- und Wiederherstellung-
schirurgie, Leipzig, Germany (C. Josten). Non-operative study arm:
both non-operative and operative treatment can be consid- York District Hospital, York, United Kingdom (P. De Boer)
ered viable options for two-part humerus fractures. Fur-
ther sufficiently powered randomised controlled trials are
warranted to identify patients who will benefit most from References
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