J Shoulder Elbow Surg (2024) 33, 343–355

www.elsevier.com/locate/ymse

ELBOW

Elbow hemiarthroplasty and total elbow

arthroplasty provided a similar functional
outcome for unreconstructable distal humeral
fractures in patients aged 60 years or older: a
multicenter randomized controlled trial
€ Jonsson, MD, PhDa,b,*, Carl Ekholm, MD, PhDa,b,
Eythor O.
€rnsson Hallgren, MD, PhDc, Jens Nestorson, MD, PhDc, Mikael Etzner, MDd,
Hanna Bjo
Lars Adolfsson, MD, PhDc,e

a
Department of Orthopaedics, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg,
Gothenburg, Sweden
b
Department of Orthopaedics, Sahlgrenska University Hospital, M€olndal, Sweden
c
Division of Orthopaedic Surgery, Department of Biomedical and Clinical Sciences, Link€oping University, Link€
oping,
Sweden
d
Hallands Hospital Varberg, Varberg, Sweden
e €
Department of Orthopaedics, Orebro €
University, Orebro, Sweden

Background: Semiconstrained total elbow arthroplasty (TEA) is an established treatment for elderly patients with distal humeral frac-
tures not amenable to stable internal fixation (unreconstructable). In recent years, there has been increasing interest in elbow hemiar-
throplasty (EHA), a treatment option which does not entail restrictions on weight-bearing as opposed to TEA. These 2 treatments have
not been compared in a randomized controlled trial (RCT). The aim of this study was to compare the functional outcome of EHA and
TEA for the treatment of unreconstructable distal humeral fractures in elderly patients.
Material and methods: This was a multicenter randomized controlled trial (RCT). Patients were included between January 2011 and
November 2019 at one of 3 participating hospitals. The inclusion criteria were an unreconstructable distal humeral fracture, age

60 years and independent living. The final follow-up took place after
2 years. The primary outcome measure was the Disabilities
of the Arm, Shoulder, and Hand (DASH) score. Secondary outcome measures were the Mayo Elbow Performance Score (MEPS), the
EQ-5D index, range of motion (flexion, extension, pronation, and supination) and grip strength.
Results: Forty patients were randomized to TEA (n ¼ 20) and EHA (n ¼ 20). Five patients died before completing the final follow-up,
leaving 18 EHA and 17 TEA patients for analysis. There were 31 women. The mean age was 74.0 (SD, 8.5) years in the EHA group and
76.9 (SD, 7.6) in the TEA group (P ¼ .30). The mean DASH score was 21.6 points in the EHA group and 27.2 in the TEA group
(P ¼ .39), a difference of 5.6 points (95% CI: 18.6 to 7.5). There were no differences between treatment with EHA and TEA
for the mean values of the MEPS (85.0 vs. 88.2, P ¼ .59), EQ-5D index (0.92 vs. 0.86, P ¼ .13), extension (29 vs. 29 , P ¼ .98), flexion
(126 vs. 136 , P ¼ .05), arc of flexion-extension (97 vs. 107 , P ¼ .25), supination (81 vs. 75 , P ¼ .13), pronation (78 vs. 74 ,

This study was approved by the Swedish Ethical Review Authority (study *Reprint requests: Eythor O. € Jonsson, MD, Sahlgrenska Uni-
no. 2010/342-31). versitetssjukhuset, Omr
ade 3 Ortopedi, M€olndal SE-431 80, Sweden.
E-mail address: eythororn@gmail.com (E.O.€ Jonsson).

1058-2746/Ó 2023 The Author(s). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
https://doi.org/10.1016/j.jse.2023.08.026
344
P ¼ .16) or grip strength (17.5 kg vs. 17.2 kg, P ¼ .89). There were 6 adverse events in each treatment group.
Conclusion: In this RCT, both elbow hemiarthroplasty (EHA) and total elbow arthroplasty (TEA) resulted in a good and similar func-
tional outcome for unreconstructable distal humeral fractures in elderly patients at a minimum of 2 years of follow-up.
Level of evidence: Level I; Randomized Controlled Trial; Treatment Study
Ó 2023 The Author(s). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Distal humeral fracture; elderly; elbow hemiarthroplasty; total elbow arthroplasty; functional outcome; elbow arthroplasty
Distal humeral fractures are not particularly common,
representing approximately 0.9% of all fractures of the ex-
tremities and axial skeleton.9 They are, however, recognized
as being difficult to treat. Surgical treatment is generally
thought to provide better results than nonsurgical treat-
ment39,49 and is preferred for most patients.3 Nevertheless,
even with the use of modern surgical techniques, adverse
events frequently occur (23%-42%) and impaired function is
still commonplace.56 Open reduction and internal fixation
(ORIF) is the most commonly used surgical technique,14,22
but some injuries do not lend themselves to internal fixa-
tion due to insufficient screw purchase. These injuries have
been referred to as being unreconstructable,38 although the
definition remains subjective. Factors that can contribute to
insufficient purchase include thin articular fragments,
comminution of the articular block and poor bone quality,
which becomes more pronounced with increasing age.43
Previous studies have indicated that total elbow arthro-
plasty (TEA) provides better function26,34 and a lower risk
of adverse events26 than ORIF in elderly patients with
comminuted intra-articular fractures of the distal humerus.
Following the promising results of early studies published
around the turn of the millennium,16,21,47 the use of TEA
for treating distal humeral fractures increased consider-
ably.32 One drawback of TEA is that patients are typically
recommended to restrict weight-bearing31,35,38 in an
attempt to minimize the risk of implant loosening, which
remains a considerable problem.44,59
In recent years, interest in elbow hemiarthroplasty
(EHA) has increased and a number of cohort studies indi-
cate a reasonable functional outcome.2,25,40,52 The most
noticeable advantage of EHA is that, as opposed to TEA,
weight-bearing is not typically restricted, as there is no
polyethylene wear or force transfer between components
due to the absence of a mechanical coupling. Potential
concerns relating to EHA include instability and erosion of
the ulnar joint surface.10,11 The outcome of these 2 different
types of elbow arthroplasty for treating unreconstructable
distal humeral fractures has not been compared in a ran-
domized controlled trial (RCT).
The aim of this study was to compare the functional
outcome of elbow hemiarthroplasty (EHA) and total elbow
arthroplasty (TEA) for unreconstructable distal humeral
fractures in elderly patients, testing the hypothesis that
EHA would provide a better functional outcome than TEA
using the Disabilities of the Arm, Shoulder and Hand
€ Jonsson et al.
E.O.
(DASH)24 score as the primary outcome measure. The
secondary outcome measures were the Mayo Elbow Per-
formance Score (MEPS),29 the EQ-5D instrument,18 range
of motion, and grip strength.
Material and methods
Trial design and eligibility criteria
This was a multicenter randomized controlled trial (RCT). The
inclusion criteria were a distal humeral fracture not amenable to
stable internal fixation (ie, unreconstructable), age
60 years and
independent living. Amenability to internal fixation was assessed
based on radiographs, computed tomography images and intra-
operative findings. The presence of 2 or more articular fragments
of considerable size and devoid of soft tissue attachment was
taken as an indication for considering arthroplasty. The exclusion
criteria were an inability to restore elbow stability (eg, unrecon-
structable radial head fracture, unreconstructable distal humeral
column, epicondyle or ligaments) which precludes the use of
EHA, degenerative disease of the elbow, pathologic fracture,
inability to participate in follow-ups (eg, cognitive impairment or
inability to communicate in Swedish) and pre-existing upper ex-
tremity condition (eg, arthritis or trauma sequelae) or concurrent
injury (eg, distal radius fracture) considerably affecting function.
This study was approved by the Swedish Ethical Review Au-
thority, reference number: 2010/342-31. All patients provided
written informed consent to participate in the study. The study was
reported in accordance with the Consolidated Standards of
Reporting Trials (CONSORT) guidelines.53
Study settings
Patients were recruited at 3 hospitals in Sweden: Sahlgrenska
University Hospital, Gothenburg; Link€oping University Hospital,
Link€oping; and Hallands Hospital Varberg, Varberg.
Interventions
The procedures were performed by 7 surgeons with extensive
experience of elbow arthroplasty. Patients underwent surgery in the
lateral decubitus position with the upper arm resting on an arm
support. The approach was made according to a predefined protocol
which included the use of a posterior skin incision and a sterile
tourniquet. The joint was exposed using a lateral para-olecranon
approach57 in all cases but also from the medial side when neces-
sary. The prostheses were inserted according to instructions from
EHA vs. TEA – distal humeral fractures
Figure 1 A distal humeral fracture treated with an elbow
hemiarthroplasty (EHA). The medial column was fixed with a
plate while the lateral epicondyle was fixed to the shaft with a
cerclage.
the manufacturers. Perioperatively, cloxacillin was administered for
infection prophylaxis, but clindamycin was used in the event of
penicillin allergy. All components were fixed with cement restric-
tors being inserted into the IM canal. The ulnar nerve was routinely
left in situ but transposed if it was under undue tension.
Elbow hemiarthroplasty (EHA)
The collateral ligaments were preserved, along with any attached
fragments required for the subsequent restoration of continuity of
345
the ligaments with the humerus. Remaining articular fragments were
removed. Following the insertion of the Latitude Anatomic (Wright
Medical, a subsidiary of Stryker, Kalamazoo, Michigan, USA), joint
stability was achieved by reducing and fixing fractures of the col-
umns or epicondyles to the humerus and repairing ligaments as
necessary, Figure 1. Fixation was performed using one of or a
combination of the following methods: osteosutures to the column
with either wires or heavy nonabsorbable sutures, fixation to the
prosthesis with nonabsorbable sutures anchored in the cannulated
screw in the center of the spool, cerclage sutures or wires embracing
one of the distal arms of the humeral component, K-wires, or plates.
Postoperatively, the elbow was immobilized in a plaster back
slab for 2-7 days. Active extension against any resistance was
avoided until 4 weeks postoperatively and the soft tissues were
protected by using either a resting splint or a brace. Active range
of motion exercises were then initiated, progressing to unrestricted
use after approximately 3 months.
Total elbow arthroplasty (TEA)
The columns and epicondyles were repaired after TEA in a similar
fashion as for EHA, if this could be accomplished with reasonable
effort but were otherwise resected. The components were linked in
all patients. The radial head was excised if it interfered with
motion. Radial head implants were not used. Postoperatively, the
elbow was immobilized with a plaster splint in slight flexion for 1-
2 days, whereafter there were no restrictions in range of motion,
but patients were advised to limit weight-bearing to a lifelong
maximum of 5 kg. Two types of semiconstrained elbow arthro-
plasty were used for TEA: Latitude Total Elbow Arthroplasty
(Wright Medical, a subsidiary of Stryker, Kalamazoo, Michigan,
USA) and the Discovery Elbow System (Lima, Villanova di San
Daniele del Friuli, Udine, Italy).
Assessment of outcome
The final follow-up was conducted at a minimum of 2 years from
injury and consisted of a clinical examination, radiographs and
completing the Disabilities of the Arm, Shoulder and Hand
(DASH),24 Mayo Elbow Performance Score (MEPS)29 and the
EQ-5D instrument.18 The DASH score was the primary outcome
measure. In this study, the 3-level version (3 response options) of
the EQ-5D was used and the EQ-5D index was calculated using
model 4 described by Burstr€ om et al.13
Clinical examination included measuring maximum flexion,
extension, supination, and pronation in degrees ( ) using a uni-
versal goniometer. Grip strength was measured using a handheld
hydraulic dynamometer with the elbow in 90 of flexion and the
shoulder, forearm, and wrist in neutral positions, with the results
being reported in kilograms (kg) as the mean of 3 attempts.48
Instability was defined as a history of subjective instability in
combination with excessive laxity, as compared with a contralat-
eral elbow, when applying varus or valgus stress or on examina-
tion for posterolateral or posteromedial instability. The motor and
sensory function of the ulnar nerve was assessed clinically and
graded using a modified McGowan classification.15 The clinical
assessment was performed by one of the authors (the majority by
the first and last authors), who were not blinded to treatment
allocation. Adverse events were identified by asking patients about
their occurrence and by reviewing medical records.
346
Radiographic assessment
Fractures were classified according to the AO Foundation/Ortho-
paedic Trauma Association (AO/OTA) fracture classification.36 In
the AO classification, fractures below and through the transcondylar
axis (TA) are grouped together in the 13C1.3 subgroup. These in-
juries were further defined in the present study according to their
level, ie, through or below the TA based on the most distal trans-
verse fracture line. Injuries were considered as being below the TA if
there was a transverse fracture line in the articular block at or below
the level of the inferior portion of the medial epicondyle. Fractures
were assessed based on preoperative radiographs and CT scans.
For patients in both treatment groups, radiographs from the
final follow-up were assessed and compared with postoperative
radiographs noting signs of loosening such as migration (subsi-
dence or tilt) or fractures of the cement mantle. The width of any
radiolucent lines, on AP or lateral views, in zones as defined by
Wagener et al,61 was recorded for both the implant-cement and
bone-cement interfaces. Components with radiolucent lines over
1 mm in width extending around the body and stem were
considered to be radiographically loose.60 AP radiographs of
EHAs were assessed for the nonunion of epicondyles or columns.
Ulnar erosion of EHAs (on AP radiographs) was assessed based
on the method described by Smith and Hughes55 but clarified as
follows: Grade 0, none; Grade 1, partial-thickness cartilage loss;
Grade 2, full thickness cartilage loss (at least part of the prosthesis
in contact with the subchondral bone of the greater sigmoid
notch); Grade 3, bone loss (at least partial erosion of the sub-
chondral bone of the greater sigmoid notch). An author not
involved in the treatment of the patients (E.O.J.)€ and an author
involved in the treatment of some of the patients (L.A.), both
experienced in elbow arthroplasty, independently classified frac-
tures, and assessed radiographs from the final follow-up. Any
discrepancies were resolved through consensus discussions.
Sample size
When the study was planned, a suitable estimate of the minimal
important difference (MID) of the DASH score was not available.
An MID of 10 points and a standard deviation (SD) of 10 points
was considered reasonable. To detect a difference of 10 points
with 80% power and a two-sided 5% significance level, a mini-
mum of 16 patients would be required in each treatment group.
Allowing for a potential loss to follow-up of 20% (4 patients in
each treatment group), recruiting 20 patients in each treatment
group was regarded as adequate.
Randomization
Randomization was performed in blocks of 10 using sequentially
numbered, sealed opaque envelopes. Patients with fractures un-
likely to be amenable to stable internal fixation were randomized
preoperatively, although the final decision to perform arthroplasty
was based on an intraoperative assessment of the fracture.
Data management and statistical methods
The data were computerized using Filemaker Pro (version 15;
Claris International, Santa Clara, CA, USA). Analysis was
€ Jonsson et al.
E.O.
performed in SPSS (version 28; IBM, Armonk, NY, USA). Data
are presented as the mean (SD) for continuous variables and as n
and (%) for categorical variables. The results of statistical tests
were considered significant at P < .05. For comparisons between
groups, the independent samples t-test and the Mann-Whitney U
test were used for continuous variables but Fisher’s exact test or
the chi-square test for categorical variables. P values are based on
t-test unless otherwise stated.
Results
Participant flow
From January 2011 to November 2019, 20 patients were
randomized to elbow hemiarthroplasty (EHA) and 20 pa-
tients to total elbow arthroplasty (TEA). Figure 2 shows the
flow of patients through the study. Five patients, 2 in the
EHA group and 3 in the TEA group, died (0.4-2.6 years
after injury) before completing the final follow-up and they
were excluded from further analysis. No adverse events
were recorded for 4 of the deceased patients, but 1 patient
in the TEA group had a periprosthetic joint infection. The
infection had, however, been eradicated with debridement,
antibiotics and implant retention (DAIR) before the patient
passed away due to unrelated reasons. As a result, 18 EHA
patients and 17 TEA patients completed the final follow-up
and were included in the analysis. There were no differ-
ences between patients who completed and did not com-
plete the final follow-up in the demographic and clinical
characteristics presented in Table I. One patient in the EHA
group was revised to TEA 10 days after the primary pro-
cedure due to subluxation resulting from failure of plate
fixation of the medial column. This patient was analyzed on
an intention-to-treat basis. The mean number of years be-
tween surgery and the final follow-up was 2.7 for the EHAs
and 2.2 years for the TEAs (P ¼ .08). The last follow-up
was conducted in November 2021.
Baseline, demographic, and clinical characteristics
There were no statistically significant differences between
the treatment groups in terms of the demographic and
clinical characteristics presented in Table I. Two patients in
the TEA group had open fractures, with wounds <1 cm and
2 cm in length corresponding to Gustilo-Anderson23 grades
I and II, respectively. Neither of these patients developed an
infection. The Latitude Anatomic was used for all EHAs
and a Latitude total elbow arthroplasty for all TEAs, except
for 1 patient treated with the Discovery Elbow System. The
ulnar nerve was left in situ, except for 1 EHA patient in
whom anterior subcutaneous transposition was considered
necessary. Fractured epicondyles and columns were
repaired for all patients in the EHA group while in the TEA
group resection of the lateral epicondyle was done in 3
cases and of both epicondyles in 1 case.
EHA vs. TEA – distal humeral fractures
n = 40
Randomized
n = 20
Allocated to
Elbow hemiarthroplasty (EHA)
20 Received allocated intervention
n=1
Discontinued intervention
1 Revised to TEA*
n=2
Lost to follow-up
2 Deceased
n = 18
Analyzed
Figure 2 Flow of patients with unreconstructable distal humeral fractures through a study comparing elbow hemiarthroplasty (EHA) and
total elbow arthroplasty (TEA). )Included in the analysis on an intention-to-treat basis.
In both treatment groups, the most common AO/OTA
group was C1 (Table I), with all these fractures being of the
C1.3 (through or below the transcondylar axis) subgroup.
Except for 1 fracture in each treatment group which was
through the transcondylar axis, the C1.3 fractures were
below the transcondylar axis (Fig. 3), indicating very thin
articular fragments. Most of the C1.3 fractures were
comminuted and most of the B3 (partial articular, frontal/
coronal plane) fractures involved a large part of the joint
surface, Figure 3.
Outcome
The mean DASH score, the primary outcome measure, was
21.6 points in the EHA group and 27.2 points in the TEA
group, P ¼ .39, Table II and Figure 4. There were no sta-
tistically significant differences in elbow function between
the treatment groups in terms of the mean MEPS scores and
range of motion or for any other secondary outcome mea-
sure, Table II. In the EHA group, 6 patients (35%) obtained
at least a functional arc of flexion-extension (30 -130 )37
compared with 10 patients in the TEA group (59%),
P ¼ .30. There was no statistically significant difference
(P ¼ .50) in the distribution of responses to the pain item in
the MEPS between EHA and TEA (n): none (10 vs. 12),
mild (5 vs. 3), moderate (3 vs. 1), and severe (0 vs. 1). None
of the patients in the EHA group had instability at the time
of the final follow-up.
347
n = 20
Allocated to
Total elbow arthroplasty (TEA)
20 Received allocated intervention
n=0
Discontinued intervention
n=3
Lost to follow-up
3 Deceased
n = 17
Analyzed
Six patients had ulnar nerve dysfunction, 4 in the EHA
group, and 2 in the TEA group, P ¼ .66. The 4 patients in
the EHA group had mild paresthesia without any intrinsic
muscle dysfunction (Grade I). Both patients in the TEA
group had constant paresthesia and moderate intrinsic
muscle weakness (Grade II B).
Radiographic assessment
Fifteen patients in the EHA group and 14 patients in the
TEA group had radiographs available from the final follow-
up and were included in the radiographic analysis after the
exclusion of the patient who was revised from EHA to
TEA. Migration of the humeral stem was detected in 3
patients. One patient in the TEA group had mild activity-
related pain, while 1 EHA patient and 1 TEA patient had no
clinical symptoms of loosening. Ulnar erosion of grade I
(partial-thickness cartilage loss) was detected in 1 patient in
the EHA group. There were 2 cases of nonunion in the
EHA group: one was a fracture of the lateral column fixed
with tension band wiring and the other was a fracture of the
medial column fixed to the prosthesis with sutures. Neither
of these patients had clinically detectable instability or pain
at the final follow-up.
Adverse events
Six adverse events were recorded in each treatment group,
Table III. One patient in the TEA group, who declined
348 € Jonsson et al.
E.O.

Table I Baseline demographic and clinical characteristics for analyzed patients (n ¼ 35) by treatment group, elbow hemiarthroplasty
(EHA) compared with total elbow arthroplasty (TEA)
EHA (n ¼ 18) TEA (n ¼ 17) Difference, mean (95% CI) P value*
Age, mean (SD), y 74.0 (8.5) 76.9 (7.6) 2.9 (8.4 to 2.7) .30
Gender, n (%) 1.0y
Female 16 (89) 15 (88)
Male 2 (11) 2 (12)
Right side dominant, n (%) 18 (100) 16 (94) .49y
Dominant side injured, n (%) 6 (33) 6 (35) 1.0z
Mechanism of injury, n (%) .93y
Ground level fall 13 (72) 11 (65)
Fall on stairs 3 (17) 3 (18)
Bicycle accident 1 (6) 2 (12)
Other 1 (6) 1 (6)
AO/OTA classification
B3x 9 (50) 4 (24) .12y
C1k 8 (44) 13 (77)
C3 1 (6) 0 (0)
Days from injury to surgery, mean (SD) 7.7 (4.7) 8.1 (4.1) 0.5 (3.5 to 2.6) .76
Duration of surgery in minutes, mean (SD) 138 (36.0) 147 (38.5) 10 (35 to 16) .45
Study center, n (%) .72y
Hallands Hospital Varberg 2 (11) 3 (18)
Link€oping University Hospital 11 (61) 8 (47)
Sahlgrenska University Hospital 5 (28) 6 (35)
EHA, elbow hemiarthroplasty; TEA, total elbow arthroplasty; CI, confidence interval.
Data are presented as the mean (SD) for continuous variables but as n (%) for categorical variables.
*For comparisions between groups, the independent samples t-test was used for continuous variables but Fisher’s exact testy or the chi-square testz for
categorical variables.
x
All were of subgroup 13B3.3 except for 1 patient in the EHA group who had a 13B3.1 fracture.
k
All were of subgroup C1.3 (through or below the transcondylar axis).

Figure 3 Three-dimensional (3D) computed tomography images of very distal and comminuted distal humeral fractures. A coronal shear
fracture involving the whole width of the articular surface (A). Anterior (B) and posterior (C) views of a fracture regarded as being below
the transcondylar axis, as the most distal fracture line enters the trochlea below the level of the inferior portion of the medial epicondyle
(arrow).
 EHA vs. TEA – distal humeral fractures
Table II Outcome at final follow-up (minimum of 2-y) by treatment group, elbow hemiarthroplasty (EHA), and total elbow arthroplasty (TEA), for clinical rating systems (DASH
score, MEPS and EQ-5D index), grip strength, and range of motion (extension, flexion, arc of flexion-extension, supination, and pronation)
EHA (n ¼ 18) TEA (n ¼ 17) Comparison between treatment groups
Mean Median Mean Median Mean Median
(SD) (range) (SD) (range)
Difference, P value* Difference P valuey
(95% CI*)
DASH score, points 21.6 (16.6) 19.6 (0-60.8) 27.2 (21.1) 25.9 (0-86.2) 5.6 (18.6 to 7.5) .39 6.3 .32
MEPS, points 85.0 (17.6) 92.5 (45-100) 88.2 (17.7) 95.0 (35-100) 3.2 (15.4 to 8.9) .59 2.5 .55
EQ-5D indexz 0.92 (0.08) 0.93 (0.68-0.97) 0.86 (0.14) 0.89 (0.40-0.97) 0.06 (0.02 to 0.14) .13 0.04 .06
Grip strength,x kg 17.5 (7.0) 17.5 (4.0-30.0) 17.2 (7.6) 17.5 (6.0-36.7) 0.4 (4.9 to 5.7) .89 0 .81
Range of motion,k
degrees
Extension 29 (12) 30 (5-46) 29 (18) 30 (0-60) 0 (11 to 11) .98 0 .89
Flexion 126 (15) 130 (90-145) 136 (11) 136 (105-151) 9 (19 to 0) .05 6 .05
Arc of 97 (22) 100 (60-130) 107 (25) 111 (50-145) 9 (26 to 7) .25 11 .15
flexion-extension
Supination 81 (9) 80 (65-95) 75 (14) 80 (50-93) 6 (2 to 15) .13 0 .19
Pronation 78 (5) 80 (70-85) 74 (10) 75 (45-90) 4 (2 to 10) .16 5 .16
EHA, elbow hemiarthroplasty; TEA, total elbow arthroplasty; DASH, Disabilities of the Arm, Shoulder and Hand; MEPS, Mayo Elbow Performance Score; SD, standard deviation; CI, confidence interval.
Data are presented as the mean (SD) for continuous variables but as number (percentage) for catergorical variables.
For comparisions between groups, the independent samples t-test* and Mann-Whitney U-testy were used.
z
The EQ-5D index was missing for 1 patient in each treatment group.
x
Grip strength was missing for 2 patients in the EHA group and 1 patient in the TEA group.
k
Flexion and extension were missing for 1 patient in the EHA group. Supination and pronation were missing for 2 patients in each treatment group.

349
350
Figure 4 The distribution of DASH scores by treatment group, elbow hemiarthroplasty (EHA) and total elbow arthroplasty (TEA).
surgical treatment for her olecranon fracture, went on to
develop nonunion and ulnar neuropathy. For the remaining
patients who experienced adverse events, treatment either
improved or resolved the problem, including 2 patients who
had periprosthetic joint infections which were eradicated
after DAIR procedures.
Discussion
The main finding in this RCT including elderly patients
with unreconstructable distal humeral fractures is that
elbow hemiarthroplasty (EHA) and total elbow arthroplasty
(TEA) provided a similar functional outcome at a minimum
of 2 years of follow-up.
The mean DASH score, the primary outcome measure,
was lower for EHA (21.6) than for TEA (27.2), but this
difference was not statistically significant (P ¼ .39) and the
observed difference of 5.6 points is lower than estimates of
the minimal important difference (MID) reported for the
DASH. Studies using the mean change method and truly
assessing a minimal change17 have reported MID estimates
in the range of 7-12 points.20,27,33 Moreover, the observed
difference is also lower than estimates of the smallest
detectable change (SDC) reported for the DASH, ranging
from 12-19 points.27,30,33,51 The SDC has been defined as the
smallest change that can be detected by an instrument
beyond measurement error.58 Patients in both treatment
groups can be seen as having obtained good function, as their
DASH scores are comparable to population-based normative
data reported by Aasheim and Finsen.1 In this Norwegian
study, women over the age of 60 years, a group demo-
graphically equivalent to the majority of the patients included
€ Jonsson et al.
E.O.
in the current study, had a mean DASH score of 23 points,
which is comparable to the mean value in both the EHA and
TEA groups. There were no clear differences between the
treatment groups in the secondary outcome measures.
No previous studies comparing EHA and TEA for the
treatment of distal humeral fractures are available but the
results of the current study are in line with cohort studies
reporting on either treatment separately.12,28,56,63 In a
recent review, Burden et al12 specifically compared EHA
(n ¼ 112) and TEA (n ¼ 538) for acute distal humeral
fractures, including only studies reporting the results of
treatment with contemporary implants. There was no clear
advantage for either treatment in terms of function. The
mean DASH score suggested better function for EHA (20
points) than for TEA (38 points), but statistical significance
was not assessed. DASH data were, however, available for
3 (n ¼ 83) of 18 (n ¼ 538) studies of TEA and the high
mean value was driven primarily by a single study based on
43 patients with a mean age of 79 years.5 Moreover, the
overall weighted mean MEPS scores were similar for the 2
treatments, 87 for EHA and 88 TEA. The arc of flexion-
extension was possibly more favorable for EHA than for
TEA (109 vs. 101 ). In contrast, in their recent review of
the treatment of intra-articular distal humeral fractures,
Stoddart et al56 reported similar mean values for flexion
(124 vs. 127 ) and extension (21 vs. 24 ) for EHA and
TEA, respectively. The inconsistent findings of available
reviews on the topic demonstrate the risk of bias associated
with summarizing these somewhat heterogeneous non-
randomized studies and highlight the need for randomized
trials.
Factors other than functional outcome are of potential
importance when choosing between treatment with EHA
 EHA vs. TEA – distal humeral fractures
Table III Adverse events
EHA TEA DASH score
n Treatment Timepoint Outcome n Treatment Timepoint Outcome
Periprosthetic joint infection 2
with Staphylococcus aureus
Patient 1 DAIR 34 d Eradication 27
Patient 2* DAIR 8d Eradication 27
Joint instability due to loss of 1
reduction of medial column
Patient 3 Revision 10 d Stable joint 61
to TEA
Periprosthetic fracture 2 1
Patient 4 (Humeral shaft) Brace 8 mo Union 28
Patient 5 (Olecranon) ORIF 4 mo Union 18
Patient 6 (Olecranon) Non-surgicaly <45 d Non-union 86
Prominent K-wire at medial epicondyle 1 2
Patient 7 Removal 4 mo Symptoms 20
resolved
Patient 8 Removal 15 mo Symptoms 24
resolved
Patient 9 Removal 45 d Symptoms 16
resolved
Stiffness resulting in arthrolysis 2 1
Patient 10 Arthrolysis 9 mo Improved ROM 24
Patient 11 Arthrolysis 7 mo Improved ROM 40
Patient 12 Arthrolysis and anterior 6 mo Improved ROM 34
transposition of the
ulnar nerve
EHA, elbow hemiarthroplasty; TEA, total elbow arthroplasty; DASH, Disabilities of the Arm, Shoulder and Hand; DAIR, debridement, antibiotics and implant retention; ORIF, open reduction and internal
fixation; ROM, range of motion.
* Patient number 2 underwent arthrolysis, a second revision procedure, 14 mo following primary surgery. The patient experienced an improvement in ROM and no further adverse events occurred.
y
The patient declined surgical treatment.

351
352
and TEA. For patients with significant pre-existing arthritis,
TEA is a reasonable choice. EHA is not an option if there
are any concerns about obtaining joint stability. For more
active patients, TEA is a less attractive option, considering
the restrictions in weight-bearing commonly imposed in an
attempt to minimize the risk of loosening.7 Meanwhile,
restrictions in weight-bearing are not typically imposed
after EHA as there should be no risk of loosening sec-
ondary to particle-mediated osteolysis or force transfer
between the components due to the absence of a mechan-
ical coupling. It should, however, be emphasized that,
although the short-term results are promising, reliable long-
term data on the outcome of EHA, including the risk of
loosening and revision, are currently very limited.
There was no clear difference in the occurrence of
adverse events between EHA (33%) and TEA (35%). The
relatively high frequency observed in both treatment groups
is comparable to previous reports on the surgical treatment
of distal humeral fractures with EHA,45,63 TEA28 and
ORIF.64 Most of the adverse events that occurred in the
current study are common to the surgical treatment of distal
humeral fractures irrespective of the type of surgery, such
as the removal of prominent internal fixation material,
arthrolysis, and peri-implant fractures. Three of 40 included
patients had periprosthetic joint infections, which is com-
parable to a rate of 0%-12% in the literature according to a
review by Watts et al.62 One patient in the EHA group had
instability requiring revision to TEA, which is a procedure-
specific adverse event, although seemingly not very
common.41
The current study was not designed to analyze differ-
ences in the occurrence of adverse events between EHA
and TEA. In the previously mentioned review by Burden
et al,12 the occurrence of adverse events was similar for
EHA and TEA. A recent meta-analysis found that TEA had
a lower risk of adverse events than ORIF in the treatment of
elderly patients with distal humeral fractures.26 Currently,
data on how EHA compares with ORIF are limited but a
recent systematic review found no clear difference in the
occurrence of adverse events between these treatments.42 It
remains unclear which treatment option for distal humeral
fractures is most favorable with respect to the occurrence of
adverse events, as the definition and both the length and
intensity of surveillance for adverse events differ between
studies. In addition, the severity of adverse events and not
only the frequency needs to be considered as well.
Mild ulnar erosion was detected in 1 patient in the
current study. Although biomechanical studies indicate that
ulnar erosion could be a potential concern with EHA,10,11
ulnar erosion did not appear to be a prominent clinical
problem in a recent registry study41 or in studies using a
hemiarthroplasty with an anatomically formed joint sur-
face, the Latitude Anatomic, with a mean of more than
5 years of follow-up.25,50,52 Regardless, for active patients
with unreconstructable distal humeral fractures, treatment
with EHA allows for a life without restricted weight-
€ Jonsson et al.
E.O.
bearing, at least until ulnar erosion potentially becomes
symptomatic, at which time a revision to TEA can be an
option.
Strengths and limitations
This RCT is the first study to compare the outcome of EHA
and TEA for the treatment of patients with unreconstruct-
able distal humeral fractures. Treatment followed a com-
mon strategy that was already in use at the 3 participating
hospitals before the study began. The staff at the partici-
pating hospitals have extensive experience of the treatment
of distal humeral fractures with elbow arthroplasty, which
should have contributed to a consistent treatment approach.
The extent to which the results are applicable to patients
treated in hospitals with less routine in treating distal hu-
meral fractures with arthroplasty is, however, unclear.
The results are based on and apply primarily to elderly
women, a demographic group constituting the majority of
patients incurring distal humeral fractures.8 Both younger
patients54 and males6,46 have been found to run a high risk
of revision following treatment with TEA but the results of
the current study do not directly clarify the functional
outcome of these patient groups.
One advantage of using the DASH score as the primary
outcome measure is that it is the most commonly used
patient-reported outcome measure in elbow research in
general,19 as well as for distal humeral fractures.65 In
addition, the DASH was available in a validated Swedish
language version at the time the current study began.4 A
disadvantage is that the results are affected not only by
elbow function but also by other upper extremity problems
as well which is why patients with previous upper extremity
conditions that significantly affected activities were not
included in the study. Regardless, the results of the elbow-
specific MEPS and elbow range of motion support those of
the DASH, ie, that there is no clear difference in functional
outcome between the treatment groups. Although we
believe that most of the patients fulfilling the eligibility
criteria were included in the study, complete information on
assessment for eligibility is not available.
The small sample size is a limitation. Recruiting a large
number of elderly patients with clearly unreconstructable
distal humeral fractures is difficult, as these injuries are not
very common, which is reflected by the long period of time
(almost 9 years) needed to recruit the predetermined
number of patients.
Conclusion
In this RCT, EHA and TEA provided a similar func-
tional outcome for unreconstructable distal humeral
fractures in patients
60 years of age at a minimum of
2 years of follow-up. There were no statistically
EHA vs. TEA – distal humeral fractures
significant differences between the treatment groups in
the mean DASH (Disabilities of the Arm, Shoulder and
Hand) scores, Mayo Elbow Performance Scores
(MEPS), or range of motion. Both EHA and TEA pro-
vided a good functional outcome. Although the occur-
rence of adverse events was considerable, approximately
one-third in both treatment groups, this is comparable to
what is described for the treatment of comminuted distal
humeral fractures in elderly patients in general.
Acknowledgments
The authors thank Terez Zara Hanqvist for her help with
administrative work.
Disclaimers:
Funding: This study was supported by a grant from the
Gothenburg Society of Medicine (to Dr. Jonsson).
Conflicts of interest: Dr. Ekholm has received fees from
Lima, Synthes, Stryker, Zimmer and Swemac Education
for educational talks and has received consultant fees
from Lima. Dr. Etzner has received fees from Arthrex,
Smith and Nephew, Swemac Education and Wright
Medical for educational talks and has received consul-
tant fees from Arthrex, Swemac and Wright Medical.
Dr. Adolfsson has received fees from Acumed, Synthes,
Wright Medical and Swemac Education for educational
talks. The other authors, their immediate families, and
any research foundation with which they are affiliated
have not received any financial payments or other ben-
efits from any commercial entity related to the subject of
this article.
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