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Functional Outcomes After Nonoperative Management of Fractures of The Proximal Humerus
Functional Outcomes After Nonoperative Management of Fractures of The Proximal Humerus
Functional Outcomes After Nonoperative Management of Fractures of The Proximal Humerus
www.elsevier.com/locate/ymse
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
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
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 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.
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