Functional Outcomes After Nonoperative Management of Fractures of The Proximal Humerus

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J Shoulder Elbow Surg (2009) 18, 612-621

www.elsevier.com/locate/ymse

Functional outcomes after nonoperative management


of fractures of the proximal humerus
Beate Hanson, MD, MPHa, Philipp Neidenbach, MDa, Piet de Boer, BChir, MB, FRCSa,b,
Dirk Stengel, MD, PhD, MSca,c,*

a
AO Clinical Investigation and Documentation, Dübendorf, Switzerland
b
Department of Traumatology, York District Hospital, York, United Kingdom
c
Center for Clinical Research, Unfallkrankenhaus Berlin and University Hospital of Greifswald, Berlin, Germany

Background: Prospective follow-up data after nonoperative treatment for fractures of the proximal
humerus are scarce. We studied functional outcomes and rates of complication and failure after conserva-
tive management of these common injuries.
Materials and methods: Consecutive patients aged older than 18 years presenting to the emergency
department of a large district hospital with an isolated, closed proximal humeral fracture considered suit-
able for functional treatment by the surgeon on charge were enrolled in a prospective, externally monitored
observational study. Surgeons were free to reduce the fracture and to prescribe any type of sling or brace.
Active follow-up after 12 weeks, 6, and 12 months included plain radiographs, Constant score, and Disabil-
ities of Arm, Shoulder and Hand (DASH) score.
Results: We enrolled 160 patients (118 women; mean age, 63.3  14.8 years), and 124 completed 1-year
follow-up. There were 85, 71, and 4 AO 11 A, B, and C fractures, and 75 one-part, 60 two-part, 23 three-
part, and 2 four-part and head-splitting fractures. After 1 year, the mean difference in Constant scores
between the injured and contralateral shoulder was 8.2 (95% confidence interval [CI], 6.0-10.4). The
mean difference in 1-year DASH scores to baseline assessment was 10.2 points (95% CI 7.3-13.1 points).
The risk of delayed and nonunion was 7.0% (95% CI, 3.6%-12.3%). Four patients subsequently underwent
surgical fixation, and 5 had arthroscopic subacromial decompression.
Conclusion: This study may provide reference values for future investigations and stresses ceiling effects
that will make it difficult to demonstrate a significant advantage of surgical over nonoperative treatment in
patients with proximal humeral fractures.
Level of evidence: Level 4; Prospective case series without a control group.
Ó 2009 Journal of Shoulder and Elbow Surgery Board of Trustees.
Keywords: Proximal humeral fracture; functional treatment; Constant score; Disabilities of the Arm,
Shoulder and Hand

*Reprint requests: Dirk Stengel, MD, PhD, MSc, Head, Center for Fractures of the proximal humerus and the humeral
Clinical Research, Department of Orthopedic and Trauma Surgery,
Unfallkrankenhaus Berlin and University Hospital of Greifswald
head are most common injuries worldwide.4 The reported
Unfallkrankenhaus Berlin, Warener Str 7, 12683 Berlin, Germany. incidence rates range from 21/100,000 person-years in
E-mail address: stengeldirk@aol.com (D. Stengel). Japanese men to 221/100,000 person-years in Swedish

1058-2746/2009/$36.00 - see front matter Ó 2009 Journal of Shoulder and Elbow Surgery Board of Trustees.
doi:10.1016/j.jse.2009.03.024
Nonoperative management of proximal humerus fractures 613

Figure 1 Patient selection procedure and completeness of follow-up.

women.11 According to current projections, every 20th Materials and methods


woman at 65 years of age will sustain a fracture of the
proximal humerus in her remaining life time.1 The local Institutional Review Board (York Research Ethics
The availability of modern orthopedic implants, such as Committee, UK [Reference No. YREC 02/11/006)] approved the
locking plates with excellent biomechanical stability even study, and all patients provided written informed consent.
in osteoporotic bone, may have contributed to the trend
toward surgical treatment of these fractures. Internal fixa- Study design and entry criteria
tion restores the anatomy of the proximal humerus but
requires hospitalization and is associated with the risk for All patients with a radiographically proven, closed fracture of the
implant-related complications. Functional therapy with proximal humerus admitted to the emergency department of a large
short immobilization, followed by an accelerated physio- district hospital in the United Kingdom, who were considered
therapy protocol, is a simple, convenient, noninvasive, suitable for primary nonoperative management by the physician on
ubiquitously available, and efficient management option. charge, were asked to participate in this investigation.
Court-Brown et al5-7 observed good to excellent clinical We excluded skeletally immature patients, patients presenting
results (as assessed by the Constant score) in non- to the hospital 10 days or more after injury, patients with open
fractures or multiple trauma and preexisting illness affecting the
operatively treated impacted valgus and varus fractures.
function of the upper limb, such as multiple sclerosis, paraplegia,
Apart from these series, however, little is known on phys- and others. Also excluded were patients with a history of drug or
ical recovery and deficits after conservatively treated frac- alcohol abuse and those who were deemed unlikely to cooperate
tures of the proximal humerus. or attend all scheduled study visits.
We prospectively assessed the function of the upper
extremity in a large cohort of patients who were assigned
Baseline documentation
to nonoperative treatment of a proximal humeral fracture.
Our primary objective was to obtain robust reference
On admission, patient demographics (ie, gender, age, profession,
values for the Constant score and the Disabilities of the
dexterity, smoking, concomitant diseases, and medication) and
Arm, Shoulder, and Hand (DASH) instrument in this injury characteristics (ie, accident type, energy level of trauma,
common clinical setting. Further objectives were to eval- concomitant injuries, fracture classification) were recorded. Patients
uate the duration of sick leave, complications, and treat- were asked to rate their upper limb function 1 week before the
ment failures and to model possible risk factors and accident to determine their baseline DASH score using the extended
predictors of shoulder function 1 year after the fracture 3-modular questionnaire.13 Normalized DASH scores range from
event. 0 (perfect function) to 100 (functionless extremity/joint).
614 B. Hanson et al.

Table I Differences in demographic baseline values between included and excluded patients
Item Clinical journal Study cohort Difference, % (95% CI) P
Patients, No. 172 160
Age, mean (SD), y 67.5 (18.1) 63.3 (14.8) 4.2 (0.6 to 7.8) .022
Male gender, 51 (29.7) 42 (26.3) 3.4 (e6.2 to 13.0) .490
No. (%)
Smokers, No. (%) 40 (23.5) 24 (15.0) 8.5 (0.1 to 17.0) .050
AO type, No. (%) .003
A 106 (61.6) 85 (53.1) 8.5 (e2.1 to 19.1)
B 51 (29.7) 71 (44.4) 14.7 (25.0 to 4.4)
C 15 (8.7) 4 (2.5) 6.2 (1.4 to 11.1)
AO subtype, n (%) .081
A1 39 (22.7) 32 (20.0) 2.7 (e6.1 to 11.5)
A2 25 (14.5) 23 (14.4) 0.2 (e7.4 to 7.7)
A3 42 (24.4) 30 (18.8) 5.7 (e3.2 to 14.5)
B1 38 (22.1) 55 (34.4) 12.3 (21.9 to e2.7)
B2 6 (3.5) 5 (3.1) 0.4 (e3.5 to 4.2)
B3 7 (4.1) 11 (6.9) 2.8 (7.7 to 2.1)
C1 5 (2.9) 0 (0.0) 2.9 (0.2 to 5.7)
C2 5 (2.9) 2 (1.3) 1.7 (e1.4 to 4.7)
C3 5 (2.9) 2 (1.3) 1.7 (e1.4 to 4.7)
CI, Confidence interval.

Radiographs were obtained in anterior-posterior projection and Data were entered in a Qualicare 5.1 database (Qualidoc,
Neer’s view upon admission in the emergency department and Trimbach, Switzerland), and monitored by an independent trial unit.
after manipulation. Additional computed tomography (CT) scans
were ordered at the discretion of the treating surgeon. Fractures
were classified according to the AO and Neer scheme by the Statistical analysis
physician on charge.19
Surgeons were free to reduce the fracture, if deemed necessary. Because of the observational character of this study, we did not
Complications with attempted fracture reduction were recorded. pose a formal null hypothesis. A target sample size of 120 fully
We documented the type and duration of immobilization and documented patients was deemed to yield sufficient precision of
beginning of active assisted and unrestricted mobilization as well estimated means and proportions, with standard errors not
as the need for immediate or later surgical repair. exceeding 5%. Assuming a 20% drop-out rate, we planned to
enroll 160 patients. All analyses were made according to the
intent-to-treat principle; that is, all patients who were assigned to
Follow-up conservative management were included in the final evaluation,
regardless of complications or subsequent surgery.
Patients were actively monitored and physically examined after 3, We calculated means, medians, proportions, and risks with
6, and 12 months. Primary outcome measures comprised raw their appropriate measures of distribution (ie, standard deviations,
Constant scores and differences to the contralateral, healthy ranges), as well as odds ratios (OR) and 95% confidence intervals
shoulder.3 Power was instrumentally measured by a spring balance (CI). Categoric variables were tabulated with absolute and relative
with the arm held in 90 abduction. The DASH was recorded as frequencies. We used the McNemar test for paired dichotomous
a coprimary end point at the final 12-month visit. variables, the Fisher exact test for independent dichotomous
Plain radiographs of the injured shoulder in 2 planes were variables, the Kruskal-Wallis nonparametric analysis of variance
obtained to determine fracture healing. for continuous variables and multiple group comparisons, and the
Anticipated complications included loss of reduction, fragment paired t test for intrasubject comparisons of mean values. All
dislocation, axis deviation, head necrosis, nonunion, impingement values of P were interpreted descriptively.
and shoulder stiffness, muscle weakness, neurologic sensations Univariate and multivariate logistic and linear regression anal-
(ie, tingling or numbness of the ipsilateral hand, brachial plexus yses were computed to identify variables independently associated
palsy, and others), pain, and death during follow-up. Reported with primary and secondary outcomes. The probability of fracture
complications were reviewed by the principal investigator (PdB) consolidation and return to work was estimated by the Kaplan-
and an independent data safety monitoring board to define Meier product limit method. Because it is unlikely that a fracture
whether complications were related to the fracture, fracture that had been considered united after 6 months will be classified as
treatment, or other conditions. a nonunion after 1 year, a last observation carried forward approach
Patients were further interviewed concerning their pain and was used in case of missing data at the follow-up examinations. The
shoulder mobility, and clinically examined using 3 power log-rank test was applied for comparisons of survival curves
measurements of both shoulders in abduction to individual between subgroups of patients. Statistical analyses were conducted
Constant scores of the injured and contralateral shoulder. with Stata 10 software (StataCorp, College Station, TX).
Nonoperative management of proximal humerus fractures 615

smoke, and had a higher prevalence of AO type C fractures


Table II Patient profile of the study cohort
(Table I).
Item No. % or (SD) Of the 160 patients (118 women) included, 139 (86.9%)
Patients 160 100 were available for clinical examination after 3 and 6
Age, mean (SD), y 63.3 (14.8) months, and 124 (77.5%) completed 1 year of follow-up.
Gender One patient died of reasons not attributed to the fracture,
Female 118 73.8 for a mortality rate of 0.6% (95% CI, 0.1%-3.4%).
Male 42 26.3 With a mean age of 63.3  14.8 years and a 3:1
Smokers 24 15.0
predominance of women, this cohort reflected the typical
Working status
Retired/unemployed 103 64.4
spectrum of patients sustaining a fracture of the proximal
Part-time 18 11.3 humerus (Table II). It is noteworthy that 35% were still
Full-time 38 23.8 employed part-time or full-time. Also, more than 40%
Mainly manual work 21 13.1 patients participated in sports.
Affected side Patients’ ratings of DASH scores 1 week before the
Right 78 48.8 injury with a mean of 3.7 (95% CI, 2.2-5.2) indicated
Left 82 51.3 almost perfect function of the affected shoulder and upper
Affected dominant extremity 74 46.3 limb .
Sporting activities 67 41.9 Comorbidities, mostly cardiovascular and respiratory
Cause of accident diseases, were present in 90 patients (56.3%). Conse-
Sport and leisure 69 43.1
quently, about 15% of study participants received aspirin,
Home 65 40.6
Traffic 10 6.3
10% received b-blockers, and 4% took steroids.
Work 8 5.0 The distribution of fractures suited the common clinical
Other 8 5.0 indication for nonoperative treatment, with about half of all
Soft-tissue injury (Oestern-Tscherne) fractures classified as AO type A and undisplaced, ‘‘1-part’’
0 154 96.3 injuries (Table III). However, the cohort also included 23
1 4 2.5 (14.4%) 3-part, and 71 (44.4%) AO type B fractures. A
2 2 1.3 high-energy injury occurred in 18 patients (11.3%). Six
Multiple fractures 8 5.0 patients (3.8%) had concomitant fractures of the distal
High-energy injury 18 11.3 radius (n ¼ 3), the facial bones (n ¼ 3), thumbs or fingers
Concomitant disease (n ¼ 2), and the hip joint (n ¼ 1).
Cardiovascular 46 28.8
Respiratory 17 10.6
Osteoarthritis 11 6.9
Diabetes mellitus 10 6.3
Treatment details
Psychiatric 8 5.0
Gastrointestinal 8 5.0 All participants were treated as outpatients, with initial
Rheumatoid arthritis 4 2.5 immobilization mostly achieved in a cuff and collar (Table
Neurologic 3 1.9 IV). As a rather unusual finding, attempts to reduce the
Medication fracture were made in more than one-third. Patients were
Aspirin 23 14.4 permitted to start assisted shoulder mobilization after 22.8
b-Blockers 16 10.0 days (95% CI, 20.8-24.8 days), and unrestricted mobiliza-
Glucocorticoid/ 6 3.8 tion was allowed after a mean of 35.9 days (95% CI, 33.5-
immunosuppressant
38.5 days).
Inhaler 4 2.5
Oral 2 1.2
In 7 patients (4.4%; 95% CI, 1.8%-8.8%), surgery was
NSAID or COX-II inhibitors 4 2.5 considered necessary to optimize fracture or fragment
positioning (Table V), and 4 (2.5%, 95% CI, 0.7%-6.3%)
COX, cyclooxygenase; NSAID, nonsteroidal anti-inflammatory drug.
underwent the planned procedure within the observation
period. Five patients (3.1%, 95% CI, 1.0%-7.1%) subse-
quently underwent arthroscopic subacromial decompres-
Results sion because of impingement. Three patients received intra-
articular local anesthetics. One patient underwent shoulder
Study profile and patient characteristics manipulation under general anesthesia. Another patient was
offered prosthetic replacement but refused.
Of 332 patients screened at the referring institution, 172 Treatment-related complications included 17 fracture
(51.8%; 95% CI, 46.3%-57.3%) were excluded for various displacements and losses of reduction after initial manip-
reasons (Figure 1) and enrolled in a clinical journal group. ulation (10.6%, 95% CI, 6.3%-16.5%) and 11 episodes
Patients excluded from the study were older, more likely to of impingement and shoulder stiffness (6.9%, 95% CI,
616 B. Hanson et al.

Table III Fracture details (study cohort, n ¼160)


Type AO Total
Neer A1 A2 A3 B1 B2 B3 C2 C3 No. (%) No. (%)
Nondisplaced, 1-part) 17 15 10 27 0 6 0 0 75 (46.9) 75 (46.9)
Anatomic neck, 2-part 0 1 0 0 0 0 0 0 1 (0.6) 60 (37.5)
Fracture dislocation
2-part anterior 10 0 0 0 0 0 0 0 10 (6.3)
2-part posterior 1 0 0 0 0 0 0 0 1 (0.6)
Surgical neck, 2-part 0 7 20 9 0 4 1 0 41 (25.6)
Greater tuberosity
2-part 4 0 0 3 0 0 0 0 7 (4.4)
3-part 0 0 0 15 4 1 0 1 21 (13.1) 23 (14.4)
Lesser tuberosity, 3-part 0 0 0 1 0 0 1 0 2 (3.1)
Greater/lesser tuberosity, 0 0 0 0 1 0 0 0 1 (0.6) 2 (1.3)
4-part
Head-splitting- articular 0 0 0 0 0 0 0 1 1 (0.6)
surface
Total, No. (%) 32 (20.0) 23 (14.4) 30 (18.8) 55 (34.4) 5 (3.1) 11 (6.9) 2 (1.3) 2 (1.3)
85 (53.1) 71 (44.4) 4 (2.5)

at 74.3 (95% CI, 72.0-76.5) and 8.2 (95% CI, 6.0-10.4)


Table IV Treatment details (study cohort, n ¼ 160)
after 1 year (Figure 2). Of note, these differences were only
Item No. %, (SD), gradually influenced by the severity of fracture displace-
(range)
ment (Kruskal-Wallis test, P ¼ .0791; Figure 3).
Immobilization After 1 year, the overall difference in DASH scores
Cuff and collar 110 69.2 compared with baseline assessment was 10.2 points (95%
Broad arm sling 43 27.0 CI, 7.3-13.1 points; paired t test, P < .0001; Figure 4),
Brace 6 3.8
indicating that patients had not fully recovered. Of note,
Length of immobilization
employed patients showed significantly lower differences
Mean (SD), d 24.1 (13.8)
Median (range), d 21 (1e88) between DASH scores before and after injury than part-
Fracture reposition 65 36.9 time or unemployed patients (Kruskal-Wallis test, P ¼
Fracture reposition 8 5.0 .0417; Figure 5).
under anesthesia Differences in DASH scores were comparable among
Treatment complications age groups up to the 70% percentile (< 73 years), whereas
Problems with reposition 4 2.5 Constant scores decreased slightly but monotonously with
Neurologic deficits 4 2.5 increasing age (Figure 6). Patients with fracture-related
Extensive bruising 1 1.2 complications had slightly higher differences in Constant
scores than those without complications (13.5 vs 7.1; mean
3.5%-11.9%). To enhance precision, these events were difference, 6.5; 95% CI, 0.8-12.1; P ¼ .0265). This was
merged to a composite measure for further analyses. mainly caused by episodes of shoulder impingement. No
Logistic regression failed to reveal significant associations other variables had a marked effect on shoulder function
(at conservative P < .1) between certain potential risk after 1 year (Figure 7).
factors and the composite of impingement and displace- As a striking finding, 41 of 42 employed patients
ment, although smokers may have a 2.25-times increased (97.6%) returned to work (95% CI, 87.4%-99.9%). The
risk compared with non-smokers (Table VI). Of the 17 predicted median time off work was 10 weeks (95% CI, 8-
displacements, 9 were later regarded resolved with, and 5 16 weeks for survival time data; Figure 8). There was no
without, persistent damage. Of the 11 patients with difference in sick leave between manual and nonmanual
impingement syndrome, 3 each resolved with and without workers (10 vs 9 weeks; log-rank test P ¼ .3612).
persistent damage. The remaining outcomes were unclear.
Bony union
Functional outcomes
Altogether, 93% of patients showed solid union after 1 year
Constant scores of the injured shoulder and side-to-side of follow-up. Using only the available number of patients at
differences improved steadily over time and were estimated different follow-up intervals for calculation of healing rates,
Nonoperative management of proximal humerus fractures 617

Table V Patients deemed to require or undergoing surgery


Sex Age Profession AO Neer Surgical procedure
M 59 Chartered surveyor A3 Surgical neck, 2-part Planned for pinning
F 62 University lecturer B2 Greater/lesser tuberosity, 4-part Planned for nailing
F 65 Retired A1 Greater tuberosity, 2-part Suturing
F 58 Retired B2 Greater tuberosity, 3-part ORIF
M 72 Retired A1 Greater tuberosity, 2-part Screw fixation,
greater tuberosity
F 63 Retired C3 Greater tuberosity, 3-part ORIF
F 76 Retired B1 Greater tuberosity, 3-part Offered ORIF, but refused
F, Female; M, male; ORIF, open reduction, internal fixation.

Table VI Association between potential risk factors and the composite end point of impingement and secondary loss of reduction
(logistic regression analysis)
Variable No. Impingement Dislocation Composite OR (95% CI) P
Age 0.99 (0.96-1.01) .343
Sex 1.15 (0.47-2.86) .759
Male 42 2 6 8
Female 118 9 11 20
Smoking status 2.25 (0.83-6.10) .109
Smokers 24 3 4 7
Nonsmokers 136 8 13 21
AO type 1.38 (0.61-3.14) .435
A 85 4 9 13
B 71 7 7 14
C 4 0 1 1
Neer type 1.45 (0.84-2.52) .377
1-part 75 9 2 11
2-part 60 0 10 10
3- or 4-part 25 2 5 7
Soft-tissue damage 0.94 (0.11-8.38) .956
Grade 0 154 11 16 27
Grade 1/2 6 0 1 1
Fracture reduction 1.33 (0.59-3.03) .492
Reduction 65 5 8 13
No reduction 95 6 9 15
CI, Confidence interval; OR, odds ratio.

98% showed fracture consolidation. The predicted risk of treatment for fractures of the proximal humerus. Active
delayed and nonunion with nonoperative management of follow-up and external monitoring ensured completeness of
fractures of the proximal humerus was 7.0% (95% CI, data sets and unbiased estimates. Demographic baseline
3.6%-12.3%). data suggest that the included participants are representa-
The median time to definite union was estimated at 14 tive of patients presenting to emergency departments in
weeks (95% CI, 12-16 weeks), and the time to union or Europe and the United States.
bridging callus was 13 weeks (95% CI, 12-16 weeks). Not The observed mean difference (10.2  16.5) between
surprisingly, smoking was a significant risk factor for preinjury and 1-year DASH scores was below the threshold
nonunion. Smokers had a 5.5-times increased likelihood of suggested as minimal detectable change.20 Unfortunately,
nonunion compared with smokers (20.8% vs 4.5%; OR, no minimal detectable change thresholds are currently
5.5; 95% CI, 1.5-19.9). available for the Constant score.
The degree of recovery suits the observations from
Discussion Court-Brown and others, but is still surprising.5,7,8,15,21,24
One might argue that most patients had less severe injuries
The present investigation represents one of the largest and (ie, nondisplaced, or 1-part and 2-part fractures), with
most detailed studies on outcomes after nonoperative a predictably good prognosis.
618 B. Hanson et al.

Figure 4 Box and whisker plot shows difference between


baseline and 1-year Disabilities of Arm, Shoulder and Hand
Figure 2 Box and whisker plot shows steady narrowing of
(DASH) scores. The horizontal line in the middle of each box
mean Constant scores of the injured and the contralateral shoulder indicates the median; the top and bottom borders of the box mark
over time. The horizontal line in the middle of each box indicates the 75th and 25th percentiles, respectively. The whiskers mark the
the median; the top and bottom borders of the box mark the 75th 90th and 10th percentiles. The circles designate outliers.
and 25th percentiles, respectively. The whiskers mark the 90th and
10th percentiles. The circles designate outliers.

slightly worse than those with undisplaced fractures. This


stresses the methodologic difficulties of obtaining valid
baseline values after an injury event has occurred.
The finding that age predicted both self-rated and
objective shoulder outcomes is not surprising, but older
patients regained much of their original function after 1
year. Because of compensation mechanisms, upper
extremity function as assessed by the DASH may have been
rated less impaired than shoulder mobility as specifically
measured by the Constant score.
It is widely accepted that fractures with displacement of
more than 1 cm and more than 45 of tilt need to be
surgically fixed. This rule has mainly been derived from
Neer’s classic work in 1970,19 but still needs more support
by scientific evidence.
The severity of fracture comminution and displacement
may have a more significant effect on functional outcomes
than the choice of treatment, with a clear difference in
prognosis between 3- and 4-part fractures, but not between
Figure 3 Box and whisker plot shows gradual influence of the
2- and 3-part fractures.
Neer classification on differences in Constant scores. The hori-
zontal line in the middle of each box indicates the median; the top
According to 7 recently published studies, average
and bottom borders of the box mark the 75th and 25th percentiles, Constant scores after surgically treated 2-, 3-part, and 4-
respectively. The whiskers mark the 90th and 10th percentiles. The part fractures can be estimated at 82.2 (95% CI, 77.7-86.8),
circles designate outliers. 83.9 (95% CI, 77.7-86.8), and 70.5 (95% CI, 64.9-
76.0).2,9,10,12,14,18,22
The high frequency of closed reductions in this study is
There was evidence of a healthy worker effect, with a matter of concern. Attempts to reduce a proximal humeral
fully employed patients showing smaller differences in fracture may have no, if any, effect on rates of malalign-
before and after DASH ratings. Of note, patients with more ment or functional outcomes. Given the potential risk for
displaced fractures rated their preinjury shoulder function soft tissue and plexus injuries caused by manipulation,
Nonoperative management of proximal humerus fractures 619

Figure 5 Association between Disabilities of Arm, Shoulder and Hand (DASH) scores and Constant scores and age. Percentiles include
the following age ranges in years: 1 ¼ 21-42; 2 ¼ 43-52; 3 ¼ 53-57; 4 ¼ 58-61; 5 ¼ 62-66; 6 ¼ 67-70; 7 ¼ 71-73; 8 ¼ 74-76; 9 ¼ 77-80;
10 ¼ 81-86.

did not assess the specific reason for the lack of informed
consent and withdrawals. The monitor queried whether
informed consent had been obtained, and patients without
a completed consent form were excluded according to
protocol, good clinical practice, and Institutional Review
Board mandates. This group might have included patients
who actively refused study participation because they felt
harassed, were too troubled by their acute condition, were
unwilling to attend follow-up (in contrast to those who were
unable to attend follow-up), or simply were not interested
in taking part in a clinical study. On the other hand, it may
include patients who were screened and considered ineli-
gible by the physicians on duty or those who were missed
because of unawareness of the protocol, time constraints,
and other factors.
It is difficult to decide whether the imbalance in the
clinical profile between included and excluded patients was
coincidental or shows the conditional probability of
Figure 6 Box and whisker plot shows the effect of employment a patient of being enrolled in the study. Obviously, patients
status on Disabilities of Arm, Shoulder and Hand (DASH) were not only excluded because they were considered to
differences on baseline values after 1 year of follow-up, suggestive require internal fracture fixation. Only 7 of the 15 C-type
of a healthy worker effect (Kruskal-Wallis test P ¼ .0417). The cases in the clinical journal underwent surgery, indicating
horizontal line in the middle of each box indicates the median; the that variables other than fracture severity contributed to the
top and bottom borders of the box mark the 75th and 25th selection of patients.
percentiles, respectively. The whiskers mark the 90th and 10th Second, patients were enrolled at a single institution
percentiles. The circles designate outliers.
with distinct treatment standards, compromising the
external validity of our findings. In the light of results from
a recent randomized trial,16 whether the average duration of
physicians should critically reconsider the indication for immobilization in this study was too long is open to debate.
fracture reduction.17,23 Third, the study included fractures that might be
There are obvious limits inherent to the observational considered as surgical cases at institutions that follow
design of this study. First, only half of all eligible patients a more invasive treatment philosophy. It is open to debate
were included in the study, introducing selection bias. We whether primary fracture fixation would have avoided the
620 B. Hanson et al.

Figure 7 Variables potentially influencing Disabilities of Arm, Shoulder and Hand (DASH) DASH and Constant scores after 1 year of
follow-up.

achieving solid healing, sufficient function, and strength to


return to work after 8 to 16 weeks. Patients should be
advised that smoking may significantly increase the risk of
nonunion and that they should quit smoking until fracture
consolidation. Few fractures primarily regarded suitable for
conservative management later require surgical stabiliza-
tion. Also, the risk of secondary surgical procedures, such
as arthroscopic decompression, is low.
In conclusion, although randomized trials remain the
reference standard for comparing outcomes between certain
treatment options, the noted ceiling effects will make it
difficult to detect substantial advantages of surgical fixation
over conservative management in the studied types of
Figure 8 Kaplan-Meier estimates for the probability of return- proximal humeral fractures.
ing to work (dotted line, 95% confidence interval).

17 displacements and losses of reduction. These events, Acknowledgments


however, had no effect on functional outcomes. However,
given the serious lack of comparative studies (specifically The authors, their immediate families, and any research
randomized trials) that would allow for evidence-based foundations with which they are affiliated have not
decision making in the treatment of proximal humeral received any financial payments or other benefits from any
fractures, the equipoise principle applied to patients in this commercial entity related to the subject of this article
study. There is still much uncertainty about which patients
will benefit from nonoperative treatment, plate fixation,
nailing, or arthroplasty. This demands a thorough trade-off
of the possible benefits and harms of surgical and nonsur- References
gical therapy.
Apart from the limitations, this study provides robust 1. Barrett JA, Baron JA, Karagas MR, Beach ML. Fracture risk in the
evidence that conservative management of fractures of the U.S. Medicare population. J Clin Epidemiol 1999;52:243-9.
proximal humerus is safe and effective, mainly in AO type 2. Calvo E, de M, I, de la Cruz JJ, Lopez-Martin N. Percutaneous fixation
of displaced proximal humeral fractures: indications based on the
A and B fractures. Conservative treatment may be
correlation between clinical and radiographic results. J Shoulder
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