Research Article Open Access
Szpalski et al., J Osteopor Phys Act 2017, 5:2
DOI: 10.4172/2329-9509.1000202
J Osteopor Phys Act, an open access journal
ISSN: 2329-9509
Volume 5 • Issue 2 • 1000202
*Corresponding author: Szpalski Marek, Hôpitaux Iris Sud, Department of Orthopedic
and Trauma Surgery, Brussels, Belgium, Tel: 32475230516; E-mail: mszp@skynet.be
Received April 20, 2017; Accepted June 14, 2017; Published June 21, 2017
Citation: Szpalski M, Le Huec JC, Jayankura M, Reynders P, Maas C (2017)
Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture:
First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device. J
Osteopor Phys Act 5: 202. doi: 10.4172/2329-9509.1000202
Copyright: © 2017 Szpalski M, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the original
author and source are credited.
Contralateral Prophylactic Reinforcement in Case of First Low-Energy
Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal
Fixation Device
Szpalski M
1
*, Le Huec JC
2
, Jayankura M
3
, Reynders P
4
and Maas C
5
1
Hôpitaux Iris Sud, Department of Orthopedic and Trauma Surgery, Belgium
2
Pellegrin Hospital, University Hospital of Bordeaux, France
3
Erasme Hospital, Belgium
4
University Hospital of Brugmann, Belgium
5
Clinical Research, Hyprevention, France
only 34%) [14]. Te authors also turned out that the decrease was not
signifcant for patients 80 and older, whereas the age is a major risk factor
for hip fracture [5,15,16]. In comparison to these medicinal methods,
surgical prevention has the advantage to be immediately efective,
without regular intake and several surgical techniques, including
femoroplasty, injection of silicone, and metallic spiral augmentation,
have been the object of biomechanical investigations [17-20]. But
despite their potential ability to reinforce strongly the proximal femur,
they have not been tested through clinical trials owing to their major
drawbacks (use of an important amount of cement inducing necrosis,
leading to atypical fractures and making the revision complex if need
be) [17,18]. One device - consisting in a titanium tubular screw with a
coated hydroxyapatite thread, inserted in the axis of the femoral neck
by minimally invasive surgery - was evaluated during a clinical trial,
showing the feasibility and safety of a prophylactic surgery in case of
a frst fracture in the opposite hip [21]. However patient disability has
not permitted to demonstrate the whole beneft of the device since
Keywords: Femur; Fracture; Osteoporosis; Orthopaedic; Pain
Introduction
More than 2 million hip fractures are reported annually worldwide
[1]. Te occurrence is expected to increase with growing and aging of
the population, aggravating this public health issue [2]. A hip fracture,
even with a surgical treatment well managed with high success rate,
remains a traumatic event for the elderly. Tis event ofen initiates a
radical worsening of their quality of life, including functional and vital
consequences, leading to dependency. Besides, the mortality rate afer a
frst hip fracture is between 15 and 33% at 1 year [3,4].
In the elderly population, hip fracture is ofen the result of a low-
energy fall linked to a daily life activity, and it is associated with a change
in the bone structure naturally linked to age: Osteoporosis. Around 9%
of patients treated for a hip fracture are victims of a second fracture of
the opposite side during the year following the frst fracture, and this
rate increase to 20% at 5 years, leading to a dramatic increase of the
mortality risk reaching 64% within 5 years [5].
To date, existing preventive solutions are weakly convincing; frst,
efciency of hip protectors has not been proved and they are rarely
used because of a low compliance [6]. Secondly, the efciency of the
medication treatments for osteoporosis is limited, especially because the
patient’s compliance is very low [7,8]. Te adverse side efects of these
treatments are ofen an obstacle to a long-term intake: Jaw necrosis,
oesophageal and gastric complications, atypical fractures [9-13]. On the
other hand some drug treatments are efcient to reduce the hip fracture
rate only afer 12 to 36 months of use [7]. Another study showed that the
efectiveness of these treatments were limited (risk fracture reduction of
Abstract
A prevention dedicated osteosynthesis device (Y-STRUT
®
, Hyprevention) was developed to reinforce the proximal
femur on patients with high risk of fragility hip fracture. A multicentre pilot study was initiated to evaluate the feasibility,
safety and tolerance of this device and the related operative procedure.
This clinical study is an on-going prospective series of 15 patients. Between February 2013 and December 2016, 10
patients were implanted. Patients were recruited when arriving to emergencies following a low-energy trauma leading
to a pertrochanteric hip fracture. The device was implanted in combination with bone cement into the contralateral hip
during the same anaesthesia as the fractured hip fxation. Clinical evaluation includes pain evaluation, functional status,
and osteointegration of the device.
Mean age of patients was 82 ± 7 years. Mean duration of implantation was 56 ± 19 min for Y-STRUT® implantation
and 37 ± 24 for fracture fxation in the opposite side. Mean cement quantity injected was 8 ± 1.6 ml. At 3 months,
WOMAC scores for pain and functionality were 5 and 24, respectively and 4 and 18 at 12 months. Mean follow-up is 16
± 12 months. No patient died during the follow-up. No osteolysis nor post-operative fracture were observed.
Preliminary results of this prospective study showed the feasibility, safety and tolerance of the implantation of this
new device. Further patients are required to confrm this experience and confrm effcacy of the device to reduce the
risk of contralateral hip fracture during the frst year after the frst fracture when elderly patients are at the highest risk of
fracture and mortality and the anti-osteoporosis medication prescribed at fracture is not yet effcient.
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ISSN: 2329-9509
Journal of Osteoporosis & Physical
Activity