Conservative Treatment, Plate Fixation, or Prosthesis For Proximal Humeral Fracture. A Prospective Randomized Study

Launonen et al.
BMC Musculoskeletal Disorders 2012, 13:167

http://www.biomedcentral.com/1471-2474/13/167
ST UDY PROT OCOL Open Access
Conservative treatment, plate fixation, or

prosthesis for proximal humeral fracture.
A prospective randomized study
Antti P Launonen1*, Vesa Lepola1, Tapio Flinkkil2, Niko Strandberg3, Johanna Ojanper4, Pekka Rissanen5,
Antti Malmivaara6, Ville M Mattila1, Petra Elo7, Timo Viljakka8 and Minna Laitinen1
Abstract
Background: Proximal humerus fracture is the third most common fracture type after hip and distal radius fracture
in elderly patients. A comprehensive study by Palvanen et al. demonstrated an increase in the annual fracture rate
of 13.7% per year over the past 33 years. Should this trend continue, the fracture rate would triple over the next
three decades. The increasing incidence of low-energy fractures raises questions about the optimal treatment in
terms of functional outcome, pain, and rehabilitation time, as well as the economical impact. Despite the high
incidence and costs of proximal humerus fractures, there is currently no valid scientific evidence for the best
treatment method. Several publications, including a Cochrane review outline the need for high-quality,
well-designed randomized controlled trials.
Methods/Design: The study is a prospective, randomized, national multi-center trial. The hypothesis of the trial is
that surgical treatment of displaced proximal humerus fractures achieves better functional outcome, pain relief, and
patient satisfaction compared to conservative treatment. The trial is designed to compare conservative and surgical
treatment of proximal humerus fractures in patients 60 years and older. The trial includes two strata. Stratum I
compares surgical treatment with locking plates to conservative treatment for two-part fractures. Stratum II
compares multi-fragmented fractures, including three- and four-part fractures. The aim of Stratum II is to compare
conservative treatment, surgical treatment with the Philos locking plate, and hemiarthroplasty with an Epoca
prosthesis. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score and
the secondary outcome measures will be the EuroQol-5D (EQ-5D) value, OSS, Constant-Murley Score, VAS, and 15D.
Recruiting time will be 3 years. The results will be analyzed after the 2-year follow-up period.
Discussion: This publication presents a prospective, randomized, national multi-center trial. It gives details of
patient flow, randomization, aftercare and also ways of analysis of the material and ways to present and publish the
results.
Trial registration: ClinicalTrials.gov identifier: NCT01246167
Keywords: Proximal, Humerus, Fracture, Conservative, Operative, Locking plate, Prosthesis, Philos, Epoca, RCT
* Correspondence: [email protected]
1
Department of Orthopaedics, Tampere University Hospital, Teiskontie 35,
PL2000, Tampere 33521, Finland
Full list of author information is available at the end of the article
2012 Launonen et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Launonen et al. BMC Musculoskeletal Disorders 2012, 13:167 Page 2 of 7
http://www.biomedcentral.com/1471-2474/13/167
Background diagnostic reliability of the classification. CT is often per-

Proximal humerus fracture is the third most common frac- formed to facilitate treatment decisions.
ture type after hip and distal radius fracture in elderly Approximately 15% of patients with proximal humerus
patients [1-3]. Proximal humerus fracture accounts for ap- fracture are treated surgically [9]. Several fixation methods
proximately 4% of all fractures [1-3]. Approximately 85% of have been introduced, including Kirschner-wire fixation,
the patients are treated conservatively and will regain screw fixation, plate fixation, intramedullary fixation, and
shoulder function without surgery [4]. Most of these frac- prosthesis [10]. Currently, the locking plate system is the
tures are stable and minimally or non-displaced osteopor- most frequently used method for fixation in two- and three-
otic fractures and they commonly occur in women [4]. The part fractures and a locking plate or prostheses is often
mechanism of low-energy injury in elderly patients is usu- used in displaced three- and four-part fractures in elderly
ally falling from standing height. In Finland in 2002, the age- patients [11]. With locking plates, the normal anat- omy may
adjusted fracture incidence in persons 60 years and older be restored and the range of motion (ROM) is reported to
was 105 per 100,000 person-years [5]. A comprehensive recover up to 80% to 85% that of the healthy side [10,12].
study by Palvanen et al. demonstrated an increase in the The disadvantage of the locking plates includes a rather high
annual fracture rate of 13.7% per year over the past 33 years complication rate of up to 49% [13]. A stable and usually
[5]. Should this trend continue, the fracture rate would pain-free shoulder is achieved with a prosthesis, but recovery
triple over the next three decades. of ROM is poor [10,12,14-17].
The increasing incidence of low-energy fractures raises
questions about the optimal treatment in terms of func- Evaluation of treatment
tional outcome, pain, and rehabilitation time, as well as the Tools that are widely used for measuring the mobility and
economical impact. Despite the high incidence and costs of usability of the shoulder include the Constant-Murley
proximal humerus fractures, there is currently no valid sci- score; Disabilities of the Arm, Shoulder and Hand (DASH)
entific evidence for the best treatment method. Several questionnaire; Oxford Shoulder Score (OSS); and Visual
publications, including a Cochrane review outline the need Analog Scale (VAS). In addition, the EuroQol-5D (EQ-5D)
for high-quality, well-designed randomized controlled trials. and 15D questionnaires survey the patient's general quality
The challenge for the future is to determine which patients of life through different questions pertaining to various
will benefit from surgery and to establish surgical techni- areas of life and are widely used in medical trials [18]. The
ques that produce optimal results for each fracture type. outcomes are indexed and are comparable with reference
The aim of this randomized controlled trial is to evaluate populations as well as with the patient's own results in
whether the outcome in patients over 60-years of age with other stages of the treatment. Finnish versions of the EQ-
displaced two-, three-, and four-part fractures of the prox- 5D and 15D have been validated [19,20].
imal humerus is improved by surgical intervention.
Previous studies
Although the literature on proximal humerus fractures is
Diagnosis and treatment extensive, the majority of studies lack randomization, com-
Diagnosis of proximal humerus fracture is based on clinical parators, and independent evaluation, which makes it im-
and radiologic findings and the mechanism of injury. A possible to draw clinically meaningful conclusions [21].
standard set of three radiographs from different views is Recent publications include three well done randomized,
generally obtained. The Neerss or AO (Arbeitsgemeinschaft controlled trials. Olerud et al. carried out randomized con-
fr Osteosynthesefragen) classification systems are widely trolled trials on three-part fractures, comparing nonsurgical
used to define these complex fractures [6]. Although these treatment with angle-stable plates in elderly patients. The
systems have been used extensively for many decades, their results indicated advantages in functional outcome and
reliability has been challenged. The AO system categorizes health-related quality of life favoring the locking plate, but
the fracture types into 27 fracture patterns, making its use the clinical significance remains unclear [22]. Fjalestad et al.
labor- and time-intensive and complicated (Mller 1990). studied displaced three and four-part fractures in patients
The Codman-Hertel binary fracture description system does over 60 years of age. They found no evidence that surgical
not address the fracture pathomechanism (Hertel 2004). treatment with an angle-stable device provided better
The Codman-Hertel system was improved by Resch by add- results than conservative treatment [23]. Others have
ing the pathomechanism of the fracture to the classification reported conflicting results. Olerud et al. studied displaced
[7]. In all classification systems, however, the intra- and inter- four-part fractures in elderly patients. They compared
observer agreement are graded as poor or, at best, moderate hemiarthroplasty and conservative treatment and found
[8]. Due to poor intra- and inter-observer agreement of the that arthroplasty provided a significant advantage in terms
Neers or AO classification systems, various radiographic of quality of life. The main advantage was less pain al-
protocols have been introduced to improve the though there was no difference in ROM [24].
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Launonen et al.

BMC Musculoskeletal Disorders 2012, 13:167

ST UDY PROT OCOL Open Access

Conservative treatment, plate fixation, or

Background diagnostic reliability of the classification. CT is often per-

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