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Open debridement and radiocapitellar replacement
in primary and post-traumatic arthritis of the elbow:
a multicenter study
Giuseppe Giannicola, MDa,
*, Renzo Angeloni, MDb
, Alberto Mantovani, MDc
,
Enrico Rebuzzi, MDd
, Giovanni Merolla, MDe
, Alessandro Greco, MDa
,
Federico M. Sacchetti, MDa
, Italo Nofroni, PhDf
, Gianluca Cinotti, MDa
,
Franco Postacchini, PhDa
a
Department of Orthopaedic Surgery, ‘‘Sapienza’’ University of Rome, Rome, Italy
b
Department of Orthopaedic Surgery, C.T.O. Careggi Hospital, Firenze, Italy
c
Upper Limb Unit, Mater Salutis Hospital, Legnago, Italy
d
Department of Orthopaedic Surgery. Treviso-Oderzo Hospital, Treviso, Italy
e
Unit of Shoulder and Elbow Surgery D, Cervesi Hospital, Cattolica, Italy
f
Department of Public Health, ‘‘Sapienza’’ University of Rome, Rome, Italy
Background: Postmortem and clinical studies have shown an early and prevalent involvement of the radio-
humeral joint in primary and secondary arthritis of the elbow. The lateral resurfacing elbow (LRE) pros-
thesis has recently been developed for the treatment of lateral elbow arthritis. However, few data have been
published on LRE results.
Materials and methods: A prospective multicenter study was designed to assess LRE preliminary results.
There were 20 patients (average age, 55 years). Preoperative diagnosis were primary osteoarthritis in 11
and post-traumatic osteoarthritis in 9. All patients underwent open debridement and LRE prosthesis.
Patients were evaluated preoperatively and postoperatively with the Mayo Elbow Performance Score
(MEPS), modified American Shoulder Elbow Surgeons (m-ASES) elbow assessment, and the Quick
Disabilities of the Arm, Shoulder and Hand (Quick-DASH). Mean follow-up was 22.6 months.
Results: At the last follow-up, the mean improvement of MEPS and m-ASES was 35 (P ¼ .001) and 34
(P ¼ .001) respectively; the average Quick DASH decreased by 29 (P ¼ .001). Average range of motion
was improved by 35
(P ¼.001). MEPI results were excellent in 12 patients, good in 2, and fair and poor in
3 each. Mild overstuffing was observed in 5 patients, and an implant malpositioning in 3. The implant
survival rate was 100%.
Conclusion: LRE showed promising results in this prospective investigation. Most patients had an
uneventful postoperative course and have shown a painless elbow joint, with satisfactory functional
recovery at short-term follow-up. Further studies with longer follow-up are warranted.
Italian law does not require Institutional Review Board or Ethical
Committee approval for this type of study. However, each author’s insti-
tution approved the human protocol for this investigation, and all inves-
tigations were conducted in conformity with ethical principles of research.
*Reprint requests: Giuseppe Giannicola, MD, Via Emilio Repossi 15,
C.A.P. 00158 Roma, Italy.
E-mail address: giannicola.g@tin.it (G. Giannicola).
J Shoulder Elbow Surg (2012) 21, 456-463
www.elsevier.com/locate/ymse
1058-2746/$ - see front matter Ó 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.
doi:10.1016/j.jse.2011.08.071
Level of evidence: Level IV, Case Series, Treatment Study.
Ó 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.
Keywords: Elbow; arthritis; osteoarthritis; replacement; radio-capitellar; lateral resurfacing
The lateral resurfacing elbow (LRE) prosthesis has been
recently introduced in the treatment of degenerative and
inflammatory conditions of the elbow.26
The potential
indications of this device, designed to exclusively replaced
the lateral compartment, emerged from pathologic investi-
gations showing that primary and secondary degenerative
changes of the elbow may involve the joint asymmetrically,
the radiohumeral joint being the compartment most
frequently damaged.2,7,13,15,25,28
Such degenerative changes
were present in adult patients and often remained confined
to the lateral compartment throughout life.13
Further clin-
ical studies have highlighted the prevalent involvement of
the lateral compartment.22,23,27
In particular, Rajeev and
Pooley27
reported that in a series of 117 patients com-
plaining of lateral elbow pain unresponsive to conservative
treatments, 60 showed arthritic changes limited to the
radiohumeral joint. Furthermore, the articular surfaces of
the lateral compartment appear to be more vulnerable to
trauma, such as fractures of the radial head, fractures of the
humeral capitellum, terrible triad injury, and Monteggia-
like lesion, which often cause post-traumatic degenerative
changes of the radiocapitellar joint.18,21
On the basis of these findings, a new resurfacing pros-
thesis was designed aimed at replacing only the radio-
humeral joint in patients showing primary and secondary
osteoarthritis with asymmetrical involvement of the artic-
ular surface.26
After the preliminary results reported by the
author,26
the clinical outcomes of radiocapitellar replace-
ment were evaluated in 3 patients who had a different type
of prosthesis,16
and in 1 with a malunion after humeral
shear fracture.11
We report the results of LRE in a larger
series of patients who were included in a prospective
multicenter study analyzing short-term outcomes of open
debridement and LRE in the treatment of primary and post-
traumatic osteoarthritis of the elbow.
Materials and methods
Selection and characteristics of the patients
From November 2006 to March 2010, 24 open debridement and
LRE procedures were performed in 5 Departments of Upper Limb
Surgery: 19 total LRE and 5 hemi-LRE in which only the humeral
component was implanted.
A software program was developed to standardize management
and resultevaluation,as well asto facilitate communication and data
exchange among surgeons. The software was available on-line and
divided into 6 sections: the first 5 sections included data collection,
patient details, and clinical, radiologic, and surgical details, and
section 6 included tables for clinical and radiologic follow-up.
Of the 24 patients, 4 were lost to follow-up (dropout, 16.6%);
thus, the study included 17 patients with total LRE and 3 with
hemi-LRE. There were 12 men and 8 women, with an average age
of 55 years (range, 31-73 years). All study patients had from mild
to severe pain and stiffness, essentially due to degenerative
changes in the lateral compartment associated with ulnohumeral
osteophytosis.
The operating diagnosis was primary osteoarthritis in 11
patients and post-traumatic osteoarthritis in 9. In 14 patients,
a conservative treatment with physiotherapy and nonsteroidal anti-
inflammatory drugs for more than 6 months had not been bene-
ficial. In 6 patients, intra-articular cortisone injections were
administered because of severe pain, with only temporary and
partial benefit. No elbow joint mobilizations under anesthesia
were performed before surgery.
None of the 11 patients with primary osteoarthritis had
undergone a previous surgical procedure, whereas 2 of the 9
patients with post-traumatic osteoarthritis had undergone 1 or
more operations. In particular, 1 patient had undergone arthro-
scopic debridement, without benefit, and another patient had
undergone multiple open debridements, with recurrence of pain
and stiffness.
All patients underwent preoperative clinical and imaging
evaluations with radiographs and computed tomography scanning.
Clinical evaluation was accomplished with the Mayo Elbow
Performance Score (MEPS), the modified American Shoulder and
Elbow Surgeons (m-ASES) score, and the Quick Disabilities of
the Arm, Shoulder and Hand (Quick DASH) score.4,19,24
The
MEPS considers intensity of pain, range of motion (ROM), joint
stability, and ability to perform activities of daily life (score, 0 to
100). The Mayo Elbow Performance Index (MEPI) classifies
results as excellent, good, fair, and poor. The modified ASES and
the Quick DASH consider the intensity of pain during daily
activities and the ability to accomplish such tasks.
Exclusion criteria of LRE implant were:
1. recent or active infections;
2. presence of severe neuromuscular deficit, which could jeop-
ardize elbow function, particularly of biceps and triceps
brachii muscles;
3. severe reduction of wrist and hand function;
4. severe bone loss of the posterior aspect of the lateral column,
which could compromise the stability of the humeral
component;
5. severe deformity of the radiohumeral and proximal radioulnar
joint, which could affect the implant stability of both LRE
components; and
6. marked wear of the medial compartment (ulnohumeral joint)
in patients aged older than 60.
Open debridement and radiocapitellar replacement 457
Surgical technique
Patient positioning and the surgical approach were chosen
depending on the type of open debridement required. A lateral
position was used in 13 patients, 2 were placed prone, and the
remaining 5 were placed supine with the arm supported on a table.
The arm was exsanguinated, and a pneumatic tourniquet was
applied at 250 mm Hg for a maximum of 2 hours.
A posterior midline incision was made in 18 patients, whereas
a lateral approach was used in the remaining patients. In 15
patients, deep dissection was performed using the transtricipital
approach, as described by Pooley.26,3
Briefly, a posterior midline
incision was performed, and the ulnar nerve was exposed and
protected during the remainder of the procedure.
Deep dissection was carried out through the triceps aponeurosis
and the intermuscular aponeurosis, separating the lateral head of
the triceps from the medial and long head. The anconeus and lateral
head of the triceps were retracted laterally as a single unit, and the
intermuscular aponeurosis was divided 2 cm apart from the olec-
ranon. The medial and long head of triceps was retracted medially
and the posterior capsule excised. The lateral collateral ligament
was partially released from its capitellar origin, and the elbow was
dislocated by flexing it in valgus and opening the joint with a lever
placed over the tip of the coronoid and the radial head.
In the remaining 5 patients, an extensive posterolateral
approach, as described by Kocher,20
was used. In these cases,
a proximal detachment of the lateral collateral ligament was
performed to expose the external compartment adequately. At the
end of the surgical procedure, the ligament was reattached through
transosseous sutures (in 1 patient) or with anchors (in 4 patients).
The ulnar nerve was exposed when the transtricipital access
was used, when a marked elbow stiffness was present, and in
patients with preoperative evidence of ulnar neuropathy. Anterior
and posterior capsule, loose bodies, and ulnohumeral osteophytes
were removed; ligament insertion release and debridement of the
anterior and posterior fossae were performed. After debridement,
ROM improvement was usually achieved and the LRE was
implanted. All patients had marked cartilage wear limited to the
lateral compartment, along with normal appearances of articular
cartilage of the medial compartment.
The operating technique for the LRE implant started with
implantation of the humeral component, followed by the radial
component. The operation was performed in accordance with the
guidelines described by Pooley.26
Patient details, including age, sex, side, diagnosis, surgical
approach, and type of implant, are reported in Table I.
Postoperative management
At the end of surgery, 2 drains were placed (1 intra-articular and 1
subcutaneous) for 48 hours. The elbow was immobilized in
extension with a plaster cast for 24 to 48 hours in a raised position,
and cryotherapy was applied. Adequate analgesic treatment was
prescribed to all patients.
The postoperative rehabilitation program depended on the type
of debridementperformed. Thepatients wereencouraged toperform
active and passive exercises beginning from postoperative day 2:
1. when the Kocher approach was used, active assisted elbow
flexion and extension without limitation were performed;
2. limitation to 90
of active and passive flexion for the first
3 weeks and passive gravity-assisted elbow extension for
the first 5 weeks were permitted in patients on whom the
transtricipital approach was performed, to preserve triceps
healing;
3. all patients were permitted active and passive assisted
pronation and supination at 90
of flexion in the first 4 weeks.
During the intervals between physiotherapy, the patient wore
a hinged splint or a resting splint, and cryotherapy was applied.
Patients were usually discharged on postoperative day 3 (range,
2-7 days).
In 11 patients, a 90
resting splint was used for 2 weeks after
discharge and removed only for physiotherapy. In the remaining 9
patients, an unlocked hinged brace was used all day; at night the
splint was locked alternately in maximum extension and in
maximum flexion for the following 6 weeks. In 9 patients,
continuous passive motion was used for about 1 month. All
patients performed rehabilitation therapy: 12 were assisted by
a physiotherapist, and 8 performed self-managed physiotherapy in
accordance with the surgeons’ indications. Activities of daily life
were allowed beginning after 8 weeks. Strenuous activities were
permitted after 4 to 6 months.
Follow-up
All patients underwent their last clinical and radiographic follow-
up between June and October 2010. The mean follow-up was 22.6
months (range, 6-47 months). Clinical evaluation was performed
using MEPS, the m-ASES, and the Quick DASH. Implant posi-
tioning was evaluated using preoperative and postoperative
radiographs and those taken at the last follow-up. On plain films,
we evaluated radiolucent lines and osteolysis, component posi-
tioning and size, presence of overstuffing, and quality of reduction
of the prosthetic components.
For statistical analysis, we used SPSS 13.0 software (SPSS Inc,
Chicago, IL, USA). Mean, median, and standard deviation (SD)
were calculated. The nonparametric Wilcoxon signed-rank test
and the Mann-Whitney test were used for comparison of preop-
erative and postoperative results, as well as age, sex, diagnosis,
preoperative ROM, surgical approach, and postoperative rehabil-
itation program. The level of significance was set at P  .05.
Results
Preoperative clinical evaluation
The mean MEPS score was 50 (range, 30-85; SD, 15.9) and
the mean Quick DASH score was 52 (range, 9-89; SD,
21.7). The average M-ASES score was 49 (range, 5-86;
SD, 23.5), and the mean pain score was 21 (range, 5-48;
SD, 12.6). Extension averaged 37
(range, 10
-70
; SD,
16.4
) and flexion averaged 100
(range, 30
-140
; SD,
25.2
). The average preoperative arc of movement was 65
(range, 0
-130
; SD, 25.9
). Pronation averaged 53
(range,
0
-85
; SD, 31
), and supination averaged 52
(range, 0
-
85
; SD, 31.5
). According to the MEPI, preoperative status
was poor in 15 patients, fair in 3, and good in 2.
458 G. Giannicola et al.
Clinical evaluation at last follow-up
The MEPS averaged 85 (range, 50-100; SD, 17.1) and Quick
DASH averaged 23 (range, 0-73; SD, 25). The average
M-ASES score was 83 (range, 55-100; SD, 16.7), with
a mean pain score of 44 (range, 20-50; SD, 8.8). Extension
averaged 25
(range, 0
-65
; SD, 19.5
), and flexion aver-
aged 125
(range, 25
-150
; SD, 27.8
). The average arc of
movement in extension-flexion was 95
(range, 0
-150
; SD,
34.0
). The mean pronation was 70
(range, 15
-85
; SD,
17.9
) and supination was 75
(range, 35
-85
; SD, 14.9
).
According to MEPI, results were excellent in 12 patients,
good in 2, and fair and poor in 3 patients each.
Good elbow stability was found in all but 3 patients. In
a 75-year-old patient with Parkinson disease, operated on
for primary osteoarthritis and chronic elbow instability,
a recurrent instability occurred leading to dislocation of the
prosthetic component. The patient refused further surgical
treatment. In the remaining 2 patients, mild varus and
valgus instability was found, respectively; however, both
patients reported good results at the last follow-up.
Statistical analysis
MEPS and m-ASES increased 35 and 34 points, respec-
tively, whereas the Quick DASH was decreased by an
average of 29 points. Differences were statistically signif-
icant (P ¼ .001). Intensity of pain decreased by 23 points
according to m-ASES. The difference between preoperative
and postoperative intensity of pain was statistically signif-
icant (P ¼ .001). An increase in extension of 10
(P ¼
.014), in flexion of 25
(P ¼ .001), and in arc of movement
of 30
(P ¼ .001) was observed. The comparison between
preoperative and postoperative values and between preop-
erative and postoperative scores is shown in Figure 1.
No difference was observed among patients with total
LRE and hemi-LRE. No statistical difference was observed
among patients with primary and post-traumatic osteoar-
thritis. Other variables, such as age, sex, type of surgical
access, type of immobilization, and severity of stiffness, did
not influence the clinical results.
Radiographic evaluation at final follow-up
The implant survival rate was 100% after a mean follow-up
of 22.6 months. Radiographic evaluation showed good
positioning of the implant in all but 3 patients; in the latter,
the humeral component was positioned too horizontally in
2 patients (Fig. 2) and too proximally in 1. In the first 2
patients, the implant malpositioning was associated with an
unsatisfactory clinical outcome due to extrinsic stiffness.
The third patient had good range of motion and mild
positive valgus stress.
In 5 patients, a slight overstuffing was present (Fig. 3).
Four of these patients reported satisfactory clinical outcomes,
whereas 1 patient, showing an oversizing of the humeral
component, had a poor outcome. No patients showed peri-
prosthetic radiolucent lines. In 2 patients with post-traumatic
Table I Details of the patients
Pt Age Sex Side Diagnosis Surgical approach Total/hemi-LRE)
1 54 M R OA Transtricipital Total
2 56 M R PTOA radial head fracture Kocher Total
3 49 M R OA Kocher Total
4 31 F L PTOA humeral capitellum fracture Transtricipital Hemi
5 57 M L OA Kocher Total
6 49 M L PTOA radial head fracture Kocher Total
7 53 M R OA Transtricipital Total
8 55 M R OA Transtricipital Total
9 44 M R PTOA radial head fracture Transtricipital Total
10 71 M R OA Transtricipital Total
11 60 F R OA Transtricipital Total
12 67 F R PTOA radial head fracture Kocher Total
13 54 F L PTOA humeral capitellum fracture Transtricipital Hemi
14 73 F R PTOA distal humeral (C3) fracture Transtricipital Total
15 55 F R PTOA humeral capitellum and olecranon fracture Transtricipital Hemi
16 61 F R OA Transtricipital Total
17 54 M R OA Transtricipital Total
18 59 M R OA Transtricipital Total
19 35 F L OA Transtricipital Total
20 68 F R PTOA humeral capitellum and trochlea fracture Transtricipital Total
F, female; L, left; M, male; OA, primary osteoarthritis; PTOA, post-traumatic osteoarthritis; R, right.
) Total: the humeral and radial components were both implanted; hemi: only the humeral component was implanted.
Open debridement and radiocapitellar replacement 459
osteoarthritis, the postoperative osteopenia around the
humeral stem had disappeared at the last follow-up.
Complications
Of the 20 operated-on patients, 16 were satisfied with the
surgical treatment (Fig. 4). Of the 4 unsatisfied patients
(20%), 3 had a recurrent elbow stiffness and 1 had a post-
operative worsening of ulnar neuropathy. Two of the 3
patients with elbow stiffness showed an excessively hori-
zontal positioning of the humeral component; however, this
did not appear to be related to the poor outcome.
One of the 2 patients was reoperated on for arthrolysis
and removal of heterotopic ossifications (HO) 9 months
after LRE implant. At the last follow-up, the patient com-
plained of persistence pain and limitation of daily activities,
both of which were resistant to medical and physiother-
apeutic treatment.
The second patient developed an extension stiffness of
50
caused by posterior HO. Because he complained of
limitations in working and daily activities, he was reoper-
ated on 12 months after surgery for soft tissue release
and HO removal. He reported a good result at the last
follow-up.
The third patient developed a flexion/extension anky-
losis of the elbow associated with ulnar nerve neuropathy.
The patient underwent open debridement and ulnar nerve
neurolysis. The last patient, who reported a postoperative
worsening of ulnar nerve neuropathy, refused any further
surgical treatment.
Figure 1 Results are shown for the preoperative and post-
operative Mayo Elbow Performance Score (MEPS), modified
American Shoulder and Elbow Surgeons (m-ASES), Quick
Disabilities of the Arm, Shoulder and Hand (Q-DASH) and arc of
movement (range of motion [ROM]). )Significant difference
between the preoperative and postoperative value.
Figure 2 Postoperative anteroposterior x-ray image demon-
strates the horizontal position of the humeral component.
Figure 3 Postoperative anteroposterior x-ray image of a 60-
year-old housewife 19 months after surgery shows slight over-
stuffing of components, with mild opening of the lateral side of the
ulnohumeral joint (white arrows).
460 G. Giannicola et al.
Discussion
Degenerative and inflammatory conditions frequently
involve the elbow joint asymmetrically, with a prevalent
and early involvement of the lateral compartment.2
As early
as 1967, postmortem studies highlighted that the first
degenerative changes often involve the humeral capitellum
and the radial head.13
Over time, other investigations
confirmed these findings7,12,15,23,25,27,28
and showed that
lateral degenerative changes may become clinically evident
in patients in their late 40s or early 50s and be responsible
for disabling elbow pain resistant to conservative treatment
and nonreplacement procedures.1,10,22,31
Indeed, in cases of
primary and post-traumatic osteoarthritis of the lateral
compartment, surgical procedures including synovectomy
or open or arthroscopic debridement, or both, are
often associated with poor surgical outcomes.9
However,
total elbow arthroplasty (TEA) has limited indications
in young patients with high functional demands and in
those showing no or moderate changes in the medial
compartment.6,14,16,29,30
On the basis of these observations, Pooley26
conceived
the LRE and first reported the preliminary results in 10
patients after a maximum follow-up of 18 months. The
MEPI was excellent in 6 patients, good in 3, and fair in 1. A
deep infection in 1 patient required removal of the
components; another patient, who reported a fall in the
early postoperative period, required surgery for a triceps
muscle dehiscence. A subsequent case report on LRE in
a patient with malunion after a humeral shear fracture
showed a good result at the short-term follow-up.11
Because to our knowledge these are the only reports on
patients treated with LRE, we planned a multicenter study
aimed at analyzing the preliminary results in a larger series
of patients, considering the rare indication of this pros-
thesis. The results seem to confirm the validity of open
debridement associated with LRE in pain resolution and
implant survival. In our series, 85% of the patients had
a complete resolution or marked reduction of pain associ-
ated with a significant improvement in elbow function, the
average postoperative increase of ROM being 35
in
extension/flexion, and 16 of the 20 patients were satisfied
with the surgical procedure. We believe these results are of
particular interest because the average age in our series was
55 years and most of the patients were able to resume their
work or sport activities, or both, previously abandoned
because of pain and joint stiffness.
Radiographic results were also encouraging: no implant
loosening was observed after an average of 23 months, and
we found no radiographic changes in the 7 patients with
a follow-up exceeding 3 years. These data are consistent
with those reported by Pooley,26
who found an implant
survival rate of 98%.
The radiographic evaluation showed that a correct
positioning of the humeral component is more difficult to
achieve than of the radial component. The humeral
component was too horizontal or proximal in 3 patients,
and prosthesis oversizing was observed in another patient.
A slight overstuffing was found in 25% of patients, with
moderate opening of the lateral side of the ulnohumeral
joint. Although these complications did not influence the
short-term results, overstuffing may cause overloading of
Figure 4 (A, B) Preoperative x-rays images demonstrate primary degenerative osteoarthritis in a 54-year-old manual worker. (C, D)
Postoperative x-ray images after extensive open debridement, fenestration of olecranon fossa, and implant of the lateral resurfacing elbow
show the joint space has been maintained and is symmetrical. Patient demonstrates final elbow range of movement 18 months after surgery:
(E) flexion, (F) extension, (G) supination, and (H) pronation.
Open debridement and radiocapitellar replacement 461
the inner part of the ulnohumeral joint and eventually lead
to degenerative changes in the medial compartment.
To avoid overstuffing, it is essential to ream the humeral
and radial surfaces adequately, and after the trial compo-
nents are positioned, to check the ulnohumeral joint by
direct visualization or fluoroscopy. If an opening of the
lateral part of the ulno-humeral joint is found or an asym-
metric joint is seen on fluoroscopy, an overstuffing is likely
to be present. Overstuffing is most frequently caused by an
incorrect positioning of the humeral component due to the
lack of reliable anatomic landmarks. In addition, we
observed that, especially in young patients with good bone
stock, the layer of hydroxyapatite covering the implant
might cause a mild mismatch between the trial and defin-
itive component, which may result in overstuffing. These
findings suggest implant malpositioning could be reduced
by improving the accuracy of surgical instrumentation.
Although no patient underwent LRE revision, we
believe that LRE preserves bone stock and does not
jeopardize future surgical procedures, such as interposition
arthroplasty or TEA. This may be of particular relevance in
young patients and in those with inflammatory conditions
in whom a progression of degenerative changes in the
elbow may be expected. Unlike TEA, LRE may also be
indicated in young and active patients because it is an
unlinked resurfacing prosthesis of the lateral compartment,
and the use of the limb does not seem to be limited by the
prosthesis. It should also be considered that compared with
capitellectomy, LRE restores the function of the lateral
compartment and allows recovery of elbow stability.5,8,17
This is particularly important in patients with high func-
tional demands, such as manual workers; in our series,
45% of the operated-on patients were manual workers, and
they all returned to their preoperative jobs, without limi-
tations, 6 months after surgery. No clinical and radio-
graphic signs of loosening were observed in any of these
patients.
This study has some limitations, including the variability
related to a multicenter study, for example, different
surgeons and preoperative diagnoses (primary or post-
traumatic osteoarthritis), which may require different
surgical procedures and different postoperative manage-
ment. In addition, although this is the largest series of LRE
analyzed so far, a limited number of patients were analyzed
after short-term follow-up.
Conclusions
The present investigation has shown that open debride-
ment and radiocapitellar replacement may provide
encouraging short-term results. We believe that future
development of the device may broaden its surgical
indications in traumatic and degenerative-inflammatory
elbow conditions and concomitantly reduce the need for
TEA in young patients. Further studies with longer
follow-up are warranted.
Disclaimer
The authors, their immediate families, and any research
foundations with which they are affiliated have not
received any financial payments or other benefits from
any commercial entity related to the subject of this article.
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Open debridement and radiocapitellar replacement 463

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Open debridement and radiocapitellar replacement in primary and post-traumatic arthritis of the elbow: a multicenter study

  • 1. Open debridement and radiocapitellar replacement in primary and post-traumatic arthritis of the elbow: a multicenter study Giuseppe Giannicola, MDa, *, Renzo Angeloni, MDb , Alberto Mantovani, MDc , Enrico Rebuzzi, MDd , Giovanni Merolla, MDe , Alessandro Greco, MDa , Federico M. Sacchetti, MDa , Italo Nofroni, PhDf , Gianluca Cinotti, MDa , Franco Postacchini, PhDa a Department of Orthopaedic Surgery, ‘‘Sapienza’’ University of Rome, Rome, Italy b Department of Orthopaedic Surgery, C.T.O. Careggi Hospital, Firenze, Italy c Upper Limb Unit, Mater Salutis Hospital, Legnago, Italy d Department of Orthopaedic Surgery. Treviso-Oderzo Hospital, Treviso, Italy e Unit of Shoulder and Elbow Surgery D, Cervesi Hospital, Cattolica, Italy f Department of Public Health, ‘‘Sapienza’’ University of Rome, Rome, Italy Background: Postmortem and clinical studies have shown an early and prevalent involvement of the radio- humeral joint in primary and secondary arthritis of the elbow. The lateral resurfacing elbow (LRE) pros- thesis has recently been developed for the treatment of lateral elbow arthritis. However, few data have been published on LRE results. Materials and methods: A prospective multicenter study was designed to assess LRE preliminary results. There were 20 patients (average age, 55 years). Preoperative diagnosis were primary osteoarthritis in 11 and post-traumatic osteoarthritis in 9. All patients underwent open debridement and LRE prosthesis. Patients were evaluated preoperatively and postoperatively with the Mayo Elbow Performance Score (MEPS), modified American Shoulder Elbow Surgeons (m-ASES) elbow assessment, and the Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH). Mean follow-up was 22.6 months. Results: At the last follow-up, the mean improvement of MEPS and m-ASES was 35 (P ¼ .001) and 34 (P ¼ .001) respectively; the average Quick DASH decreased by 29 (P ¼ .001). Average range of motion was improved by 35 (P ¼.001). MEPI results were excellent in 12 patients, good in 2, and fair and poor in 3 each. Mild overstuffing was observed in 5 patients, and an implant malpositioning in 3. The implant survival rate was 100%. Conclusion: LRE showed promising results in this prospective investigation. Most patients had an uneventful postoperative course and have shown a painless elbow joint, with satisfactory functional recovery at short-term follow-up. Further studies with longer follow-up are warranted. Italian law does not require Institutional Review Board or Ethical Committee approval for this type of study. However, each author’s insti- tution approved the human protocol for this investigation, and all inves- tigations were conducted in conformity with ethical principles of research. *Reprint requests: Giuseppe Giannicola, MD, Via Emilio Repossi 15, C.A.P. 00158 Roma, Italy. E-mail address: giannicola.g@tin.it (G. Giannicola). J Shoulder Elbow Surg (2012) 21, 456-463 www.elsevier.com/locate/ymse 1058-2746/$ - see front matter Ó 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2011.08.071
  • 2. Level of evidence: Level IV, Case Series, Treatment Study. Ó 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Elbow; arthritis; osteoarthritis; replacement; radio-capitellar; lateral resurfacing The lateral resurfacing elbow (LRE) prosthesis has been recently introduced in the treatment of degenerative and inflammatory conditions of the elbow.26 The potential indications of this device, designed to exclusively replaced the lateral compartment, emerged from pathologic investi- gations showing that primary and secondary degenerative changes of the elbow may involve the joint asymmetrically, the radiohumeral joint being the compartment most frequently damaged.2,7,13,15,25,28 Such degenerative changes were present in adult patients and often remained confined to the lateral compartment throughout life.13 Further clin- ical studies have highlighted the prevalent involvement of the lateral compartment.22,23,27 In particular, Rajeev and Pooley27 reported that in a series of 117 patients com- plaining of lateral elbow pain unresponsive to conservative treatments, 60 showed arthritic changes limited to the radiohumeral joint. Furthermore, the articular surfaces of the lateral compartment appear to be more vulnerable to trauma, such as fractures of the radial head, fractures of the humeral capitellum, terrible triad injury, and Monteggia- like lesion, which often cause post-traumatic degenerative changes of the radiocapitellar joint.18,21 On the basis of these findings, a new resurfacing pros- thesis was designed aimed at replacing only the radio- humeral joint in patients showing primary and secondary osteoarthritis with asymmetrical involvement of the artic- ular surface.26 After the preliminary results reported by the author,26 the clinical outcomes of radiocapitellar replace- ment were evaluated in 3 patients who had a different type of prosthesis,16 and in 1 with a malunion after humeral shear fracture.11 We report the results of LRE in a larger series of patients who were included in a prospective multicenter study analyzing short-term outcomes of open debridement and LRE in the treatment of primary and post- traumatic osteoarthritis of the elbow. Materials and methods Selection and characteristics of the patients From November 2006 to March 2010, 24 open debridement and LRE procedures were performed in 5 Departments of Upper Limb Surgery: 19 total LRE and 5 hemi-LRE in which only the humeral component was implanted. A software program was developed to standardize management and resultevaluation,as well asto facilitate communication and data exchange among surgeons. The software was available on-line and divided into 6 sections: the first 5 sections included data collection, patient details, and clinical, radiologic, and surgical details, and section 6 included tables for clinical and radiologic follow-up. Of the 24 patients, 4 were lost to follow-up (dropout, 16.6%); thus, the study included 17 patients with total LRE and 3 with hemi-LRE. There were 12 men and 8 women, with an average age of 55 years (range, 31-73 years). All study patients had from mild to severe pain and stiffness, essentially due to degenerative changes in the lateral compartment associated with ulnohumeral osteophytosis. The operating diagnosis was primary osteoarthritis in 11 patients and post-traumatic osteoarthritis in 9. In 14 patients, a conservative treatment with physiotherapy and nonsteroidal anti- inflammatory drugs for more than 6 months had not been bene- ficial. In 6 patients, intra-articular cortisone injections were administered because of severe pain, with only temporary and partial benefit. No elbow joint mobilizations under anesthesia were performed before surgery. None of the 11 patients with primary osteoarthritis had undergone a previous surgical procedure, whereas 2 of the 9 patients with post-traumatic osteoarthritis had undergone 1 or more operations. In particular, 1 patient had undergone arthro- scopic debridement, without benefit, and another patient had undergone multiple open debridements, with recurrence of pain and stiffness. All patients underwent preoperative clinical and imaging evaluations with radiographs and computed tomography scanning. Clinical evaluation was accomplished with the Mayo Elbow Performance Score (MEPS), the modified American Shoulder and Elbow Surgeons (m-ASES) score, and the Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) score.4,19,24 The MEPS considers intensity of pain, range of motion (ROM), joint stability, and ability to perform activities of daily life (score, 0 to 100). The Mayo Elbow Performance Index (MEPI) classifies results as excellent, good, fair, and poor. The modified ASES and the Quick DASH consider the intensity of pain during daily activities and the ability to accomplish such tasks. Exclusion criteria of LRE implant were: 1. recent or active infections; 2. presence of severe neuromuscular deficit, which could jeop- ardize elbow function, particularly of biceps and triceps brachii muscles; 3. severe reduction of wrist and hand function; 4. severe bone loss of the posterior aspect of the lateral column, which could compromise the stability of the humeral component; 5. severe deformity of the radiohumeral and proximal radioulnar joint, which could affect the implant stability of both LRE components; and 6. marked wear of the medial compartment (ulnohumeral joint) in patients aged older than 60. Open debridement and radiocapitellar replacement 457
  • 3. Surgical technique Patient positioning and the surgical approach were chosen depending on the type of open debridement required. A lateral position was used in 13 patients, 2 were placed prone, and the remaining 5 were placed supine with the arm supported on a table. The arm was exsanguinated, and a pneumatic tourniquet was applied at 250 mm Hg for a maximum of 2 hours. A posterior midline incision was made in 18 patients, whereas a lateral approach was used in the remaining patients. In 15 patients, deep dissection was performed using the transtricipital approach, as described by Pooley.26,3 Briefly, a posterior midline incision was performed, and the ulnar nerve was exposed and protected during the remainder of the procedure. Deep dissection was carried out through the triceps aponeurosis and the intermuscular aponeurosis, separating the lateral head of the triceps from the medial and long head. The anconeus and lateral head of the triceps were retracted laterally as a single unit, and the intermuscular aponeurosis was divided 2 cm apart from the olec- ranon. The medial and long head of triceps was retracted medially and the posterior capsule excised. The lateral collateral ligament was partially released from its capitellar origin, and the elbow was dislocated by flexing it in valgus and opening the joint with a lever placed over the tip of the coronoid and the radial head. In the remaining 5 patients, an extensive posterolateral approach, as described by Kocher,20 was used. In these cases, a proximal detachment of the lateral collateral ligament was performed to expose the external compartment adequately. At the end of the surgical procedure, the ligament was reattached through transosseous sutures (in 1 patient) or with anchors (in 4 patients). The ulnar nerve was exposed when the transtricipital access was used, when a marked elbow stiffness was present, and in patients with preoperative evidence of ulnar neuropathy. Anterior and posterior capsule, loose bodies, and ulnohumeral osteophytes were removed; ligament insertion release and debridement of the anterior and posterior fossae were performed. After debridement, ROM improvement was usually achieved and the LRE was implanted. All patients had marked cartilage wear limited to the lateral compartment, along with normal appearances of articular cartilage of the medial compartment. The operating technique for the LRE implant started with implantation of the humeral component, followed by the radial component. The operation was performed in accordance with the guidelines described by Pooley.26 Patient details, including age, sex, side, diagnosis, surgical approach, and type of implant, are reported in Table I. Postoperative management At the end of surgery, 2 drains were placed (1 intra-articular and 1 subcutaneous) for 48 hours. The elbow was immobilized in extension with a plaster cast for 24 to 48 hours in a raised position, and cryotherapy was applied. Adequate analgesic treatment was prescribed to all patients. The postoperative rehabilitation program depended on the type of debridementperformed. Thepatients wereencouraged toperform active and passive exercises beginning from postoperative day 2: 1. when the Kocher approach was used, active assisted elbow flexion and extension without limitation were performed; 2. limitation to 90 of active and passive flexion for the first 3 weeks and passive gravity-assisted elbow extension for the first 5 weeks were permitted in patients on whom the transtricipital approach was performed, to preserve triceps healing; 3. all patients were permitted active and passive assisted pronation and supination at 90 of flexion in the first 4 weeks. During the intervals between physiotherapy, the patient wore a hinged splint or a resting splint, and cryotherapy was applied. Patients were usually discharged on postoperative day 3 (range, 2-7 days). In 11 patients, a 90 resting splint was used for 2 weeks after discharge and removed only for physiotherapy. In the remaining 9 patients, an unlocked hinged brace was used all day; at night the splint was locked alternately in maximum extension and in maximum flexion for the following 6 weeks. In 9 patients, continuous passive motion was used for about 1 month. All patients performed rehabilitation therapy: 12 were assisted by a physiotherapist, and 8 performed self-managed physiotherapy in accordance with the surgeons’ indications. Activities of daily life were allowed beginning after 8 weeks. Strenuous activities were permitted after 4 to 6 months. Follow-up All patients underwent their last clinical and radiographic follow- up between June and October 2010. The mean follow-up was 22.6 months (range, 6-47 months). Clinical evaluation was performed using MEPS, the m-ASES, and the Quick DASH. Implant posi- tioning was evaluated using preoperative and postoperative radiographs and those taken at the last follow-up. On plain films, we evaluated radiolucent lines and osteolysis, component posi- tioning and size, presence of overstuffing, and quality of reduction of the prosthetic components. For statistical analysis, we used SPSS 13.0 software (SPSS Inc, Chicago, IL, USA). Mean, median, and standard deviation (SD) were calculated. The nonparametric Wilcoxon signed-rank test and the Mann-Whitney test were used for comparison of preop- erative and postoperative results, as well as age, sex, diagnosis, preoperative ROM, surgical approach, and postoperative rehabil- itation program. The level of significance was set at P .05. Results Preoperative clinical evaluation The mean MEPS score was 50 (range, 30-85; SD, 15.9) and the mean Quick DASH score was 52 (range, 9-89; SD, 21.7). The average M-ASES score was 49 (range, 5-86; SD, 23.5), and the mean pain score was 21 (range, 5-48; SD, 12.6). Extension averaged 37 (range, 10 -70 ; SD, 16.4 ) and flexion averaged 100 (range, 30 -140 ; SD, 25.2 ). The average preoperative arc of movement was 65 (range, 0 -130 ; SD, 25.9 ). Pronation averaged 53 (range, 0 -85 ; SD, 31 ), and supination averaged 52 (range, 0 - 85 ; SD, 31.5 ). According to the MEPI, preoperative status was poor in 15 patients, fair in 3, and good in 2. 458 G. Giannicola et al.
  • 4. Clinical evaluation at last follow-up The MEPS averaged 85 (range, 50-100; SD, 17.1) and Quick DASH averaged 23 (range, 0-73; SD, 25). The average M-ASES score was 83 (range, 55-100; SD, 16.7), with a mean pain score of 44 (range, 20-50; SD, 8.8). Extension averaged 25 (range, 0 -65 ; SD, 19.5 ), and flexion aver- aged 125 (range, 25 -150 ; SD, 27.8 ). The average arc of movement in extension-flexion was 95 (range, 0 -150 ; SD, 34.0 ). The mean pronation was 70 (range, 15 -85 ; SD, 17.9 ) and supination was 75 (range, 35 -85 ; SD, 14.9 ). According to MEPI, results were excellent in 12 patients, good in 2, and fair and poor in 3 patients each. Good elbow stability was found in all but 3 patients. In a 75-year-old patient with Parkinson disease, operated on for primary osteoarthritis and chronic elbow instability, a recurrent instability occurred leading to dislocation of the prosthetic component. The patient refused further surgical treatment. In the remaining 2 patients, mild varus and valgus instability was found, respectively; however, both patients reported good results at the last follow-up. Statistical analysis MEPS and m-ASES increased 35 and 34 points, respec- tively, whereas the Quick DASH was decreased by an average of 29 points. Differences were statistically signif- icant (P ¼ .001). Intensity of pain decreased by 23 points according to m-ASES. The difference between preoperative and postoperative intensity of pain was statistically signif- icant (P ¼ .001). An increase in extension of 10 (P ¼ .014), in flexion of 25 (P ¼ .001), and in arc of movement of 30 (P ¼ .001) was observed. The comparison between preoperative and postoperative values and between preop- erative and postoperative scores is shown in Figure 1. No difference was observed among patients with total LRE and hemi-LRE. No statistical difference was observed among patients with primary and post-traumatic osteoar- thritis. Other variables, such as age, sex, type of surgical access, type of immobilization, and severity of stiffness, did not influence the clinical results. Radiographic evaluation at final follow-up The implant survival rate was 100% after a mean follow-up of 22.6 months. Radiographic evaluation showed good positioning of the implant in all but 3 patients; in the latter, the humeral component was positioned too horizontally in 2 patients (Fig. 2) and too proximally in 1. In the first 2 patients, the implant malpositioning was associated with an unsatisfactory clinical outcome due to extrinsic stiffness. The third patient had good range of motion and mild positive valgus stress. In 5 patients, a slight overstuffing was present (Fig. 3). Four of these patients reported satisfactory clinical outcomes, whereas 1 patient, showing an oversizing of the humeral component, had a poor outcome. No patients showed peri- prosthetic radiolucent lines. In 2 patients with post-traumatic Table I Details of the patients Pt Age Sex Side Diagnosis Surgical approach Total/hemi-LRE) 1 54 M R OA Transtricipital Total 2 56 M R PTOA radial head fracture Kocher Total 3 49 M R OA Kocher Total 4 31 F L PTOA humeral capitellum fracture Transtricipital Hemi 5 57 M L OA Kocher Total 6 49 M L PTOA radial head fracture Kocher Total 7 53 M R OA Transtricipital Total 8 55 M R OA Transtricipital Total 9 44 M R PTOA radial head fracture Transtricipital Total 10 71 M R OA Transtricipital Total 11 60 F R OA Transtricipital Total 12 67 F R PTOA radial head fracture Kocher Total 13 54 F L PTOA humeral capitellum fracture Transtricipital Hemi 14 73 F R PTOA distal humeral (C3) fracture Transtricipital Total 15 55 F R PTOA humeral capitellum and olecranon fracture Transtricipital Hemi 16 61 F R OA Transtricipital Total 17 54 M R OA Transtricipital Total 18 59 M R OA Transtricipital Total 19 35 F L OA Transtricipital Total 20 68 F R PTOA humeral capitellum and trochlea fracture Transtricipital Total F, female; L, left; M, male; OA, primary osteoarthritis; PTOA, post-traumatic osteoarthritis; R, right. ) Total: the humeral and radial components were both implanted; hemi: only the humeral component was implanted. Open debridement and radiocapitellar replacement 459
  • 5. osteoarthritis, the postoperative osteopenia around the humeral stem had disappeared at the last follow-up. Complications Of the 20 operated-on patients, 16 were satisfied with the surgical treatment (Fig. 4). Of the 4 unsatisfied patients (20%), 3 had a recurrent elbow stiffness and 1 had a post- operative worsening of ulnar neuropathy. Two of the 3 patients with elbow stiffness showed an excessively hori- zontal positioning of the humeral component; however, this did not appear to be related to the poor outcome. One of the 2 patients was reoperated on for arthrolysis and removal of heterotopic ossifications (HO) 9 months after LRE implant. At the last follow-up, the patient com- plained of persistence pain and limitation of daily activities, both of which were resistant to medical and physiother- apeutic treatment. The second patient developed an extension stiffness of 50 caused by posterior HO. Because he complained of limitations in working and daily activities, he was reoper- ated on 12 months after surgery for soft tissue release and HO removal. He reported a good result at the last follow-up. The third patient developed a flexion/extension anky- losis of the elbow associated with ulnar nerve neuropathy. The patient underwent open debridement and ulnar nerve neurolysis. The last patient, who reported a postoperative worsening of ulnar nerve neuropathy, refused any further surgical treatment. Figure 1 Results are shown for the preoperative and post- operative Mayo Elbow Performance Score (MEPS), modified American Shoulder and Elbow Surgeons (m-ASES), Quick Disabilities of the Arm, Shoulder and Hand (Q-DASH) and arc of movement (range of motion [ROM]). )Significant difference between the preoperative and postoperative value. Figure 2 Postoperative anteroposterior x-ray image demon- strates the horizontal position of the humeral component. Figure 3 Postoperative anteroposterior x-ray image of a 60- year-old housewife 19 months after surgery shows slight over- stuffing of components, with mild opening of the lateral side of the ulnohumeral joint (white arrows). 460 G. Giannicola et al.
  • 6. Discussion Degenerative and inflammatory conditions frequently involve the elbow joint asymmetrically, with a prevalent and early involvement of the lateral compartment.2 As early as 1967, postmortem studies highlighted that the first degenerative changes often involve the humeral capitellum and the radial head.13 Over time, other investigations confirmed these findings7,12,15,23,25,27,28 and showed that lateral degenerative changes may become clinically evident in patients in their late 40s or early 50s and be responsible for disabling elbow pain resistant to conservative treatment and nonreplacement procedures.1,10,22,31 Indeed, in cases of primary and post-traumatic osteoarthritis of the lateral compartment, surgical procedures including synovectomy or open or arthroscopic debridement, or both, are often associated with poor surgical outcomes.9 However, total elbow arthroplasty (TEA) has limited indications in young patients with high functional demands and in those showing no or moderate changes in the medial compartment.6,14,16,29,30 On the basis of these observations, Pooley26 conceived the LRE and first reported the preliminary results in 10 patients after a maximum follow-up of 18 months. The MEPI was excellent in 6 patients, good in 3, and fair in 1. A deep infection in 1 patient required removal of the components; another patient, who reported a fall in the early postoperative period, required surgery for a triceps muscle dehiscence. A subsequent case report on LRE in a patient with malunion after a humeral shear fracture showed a good result at the short-term follow-up.11 Because to our knowledge these are the only reports on patients treated with LRE, we planned a multicenter study aimed at analyzing the preliminary results in a larger series of patients, considering the rare indication of this pros- thesis. The results seem to confirm the validity of open debridement associated with LRE in pain resolution and implant survival. In our series, 85% of the patients had a complete resolution or marked reduction of pain associ- ated with a significant improvement in elbow function, the average postoperative increase of ROM being 35 in extension/flexion, and 16 of the 20 patients were satisfied with the surgical procedure. We believe these results are of particular interest because the average age in our series was 55 years and most of the patients were able to resume their work or sport activities, or both, previously abandoned because of pain and joint stiffness. Radiographic results were also encouraging: no implant loosening was observed after an average of 23 months, and we found no radiographic changes in the 7 patients with a follow-up exceeding 3 years. These data are consistent with those reported by Pooley,26 who found an implant survival rate of 98%. The radiographic evaluation showed that a correct positioning of the humeral component is more difficult to achieve than of the radial component. The humeral component was too horizontal or proximal in 3 patients, and prosthesis oversizing was observed in another patient. A slight overstuffing was found in 25% of patients, with moderate opening of the lateral side of the ulnohumeral joint. Although these complications did not influence the short-term results, overstuffing may cause overloading of Figure 4 (A, B) Preoperative x-rays images demonstrate primary degenerative osteoarthritis in a 54-year-old manual worker. (C, D) Postoperative x-ray images after extensive open debridement, fenestration of olecranon fossa, and implant of the lateral resurfacing elbow show the joint space has been maintained and is symmetrical. Patient demonstrates final elbow range of movement 18 months after surgery: (E) flexion, (F) extension, (G) supination, and (H) pronation. Open debridement and radiocapitellar replacement 461
  • 7. the inner part of the ulnohumeral joint and eventually lead to degenerative changes in the medial compartment. To avoid overstuffing, it is essential to ream the humeral and radial surfaces adequately, and after the trial compo- nents are positioned, to check the ulnohumeral joint by direct visualization or fluoroscopy. If an opening of the lateral part of the ulno-humeral joint is found or an asym- metric joint is seen on fluoroscopy, an overstuffing is likely to be present. Overstuffing is most frequently caused by an incorrect positioning of the humeral component due to the lack of reliable anatomic landmarks. In addition, we observed that, especially in young patients with good bone stock, the layer of hydroxyapatite covering the implant might cause a mild mismatch between the trial and defin- itive component, which may result in overstuffing. These findings suggest implant malpositioning could be reduced by improving the accuracy of surgical instrumentation. Although no patient underwent LRE revision, we believe that LRE preserves bone stock and does not jeopardize future surgical procedures, such as interposition arthroplasty or TEA. This may be of particular relevance in young patients and in those with inflammatory conditions in whom a progression of degenerative changes in the elbow may be expected. Unlike TEA, LRE may also be indicated in young and active patients because it is an unlinked resurfacing prosthesis of the lateral compartment, and the use of the limb does not seem to be limited by the prosthesis. It should also be considered that compared with capitellectomy, LRE restores the function of the lateral compartment and allows recovery of elbow stability.5,8,17 This is particularly important in patients with high func- tional demands, such as manual workers; in our series, 45% of the operated-on patients were manual workers, and they all returned to their preoperative jobs, without limi- tations, 6 months after surgery. No clinical and radio- graphic signs of loosening were observed in any of these patients. This study has some limitations, including the variability related to a multicenter study, for example, different surgeons and preoperative diagnoses (primary or post- traumatic osteoarthritis), which may require different surgical procedures and different postoperative manage- ment. In addition, although this is the largest series of LRE analyzed so far, a limited number of patients were analyzed after short-term follow-up. Conclusions The present investigation has shown that open debride- ment and radiocapitellar replacement may provide encouraging short-term results. We believe that future development of the device may broaden its surgical indications in traumatic and degenerative-inflammatory elbow conditions and concomitantly reduce the need for TEA in young patients. Further studies with longer follow-up are warranted. 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