Sie sind auf Seite 1von 5

This paper will investigate the clinical performance of

three medical devices on the Therapeutic Goods


Administrator (TGA) Australian Register of
Therapeutic Goods (ARTG). This will be achieved
through a systematic review of the published evidence
for the clinical performance of the devices. A systematic
review provides a means for gathering, synthesizing and
appraising the findings of studies on the question posed.
It aim to minimize the bias associated with single
studies and can include many types of studies from
diverse disciplines (Moynihan, 2007). This review will
focus on three class three medical devices: Anatomique
Benoist Giraud (ABG) II Femoral Stem, Pinnacle Hip
Implant and the Durom Cup.
Before a systematic review can be undertaken,
background research into the device, manufacturing
company and sponsor is required. The ABG II Femoral
Stem is produced by Stryker. Stryker is a medical
technology development company that specializes in
reconstructive, medical and surgical, and
nuerotechnology and spine products (Lobo, 1998). The
device is design as a total hip replacement and does not
have an outsourced sponsor. The Pinnacle hip implant is
produced by DePuy, a healthcare company specializing
in orthopaedics, spinal care, sports medicine and
neurosciences (Gorsky, 2013). The device is a total hip
replacement and is sponsored by Johnson and Johnson
Pty Ltd. The Durom Cup is produced by Zimmer, a
musculoskeletal health company specializing in
orthopaedic solutions. The Durom Cup is an artificial
hip socket that allows the femur to be articulated.
The three devices presented must be critically evaluated
in order to ensure that they meet the desired clinical
performance. This will be achieved as previously stated,
through a systematic review of the evidence.
A systematic review is achieved by a 5 step process
(Khan, 2003):
1. Framing questions for a review
2. Identify relevant work
3. Assessing the quality of studies
4. Summarizing the evidence
5. Interpreting the findings
A Systematic Review of the Clinical Performance of
the Stryker AB II Femoral Stem, DePuy Pinnacle Hip
Implant and the Zimmer Durom Cup

By Lachlan McLean - 8099529


Abstract: This report focuses on the clinical performance of the Stryker ABG II Femoral Stem, DePuy
Pinnacle Hip Implant and the Zimmer Durom Cup. A 5 step systematic review was conducted on the published
evidence of the three medical devices (Khan, 2003). 13 journal articles were analysed for the clinical
performance and it was found that the ABG II Femoral stem had an overall positive association for it clinical
performance. The Pinnacle Hip Implant had no clear association, while the Durom Cup had an overall negative
association. However it



FRAMING THE QUESTION
Figure 1: Structured questions for systematic reviews and relations between question components in a
comparative study (Khan, 2003)


In order to frame the question that will be investigated,
a structural relationship between components of the
study must be developed, as shown in figure 1. Based
upon this structure, we are able to develop the free form
question of The clinical performance of the ABG II
Hip Implant, Pinnacle Hip Implant and the Durom Cup
based upon the published evidence.

IDENTIFYING RELEVANT PUBLICATIONS
In order to identify as many published citations as
possible, a wide range of medical and scientific
databases were searched. A search of ABG II Hip
Replacement from various databases and webpages
resulted in 67 citations of which 4 were deemed
relevant. The four articles were published between 2008
and 2013 and are titled: Long-Term Outcomes of a New
Model of Anatomical Hydroxyapatite-Coated Hip
Prosthesis (Herrera, 2013), The Cementless Anatomic
Benoist Girard (ABG) II Total Hip Arthroplasty A
Minimum 8-Year Follow-Up Study (Nourissat, 2013),
Femoral fit in ABG-II hip stems, influence on clinical
outcome andbone remodeling: a radiographic study
(Wal, 2008) and Study of bone remodeling of two
models of femoral Cementless stems by means of DEXA
and finite elements (Gracia, 2010).
This process was repeated for the Pinnacle Hip Implant
with a search of Depuy Pinnacle Hip Implant
undertaken. This resulted in 159 citation of which 6
were deemed relevant. The 6 articles were published
between 2006 and 2013 and are titled: Late Liner
Disassociation of a Pinnacle System Acetabular
Component (Mayer, 2012), Acetabular Component
Deformation with Press-Fit Fixation (Squire, 2006), A
Comparison of a Second and Third-Generation
Modular Cup Design (Powers, 2010), Acute Liner
Disassociation of a Pinnacle Acetabular Component
(Mesko, 2009), Minimum 5-Year Results of Modular
Metal-On-Metal Total Hip Arthroplasty (Kindsfater,
2012) and Independent predictors of failure up to 7.5
years after 35 386 single-brand Cementless total hip
replacements (Jameson, 2013).
This process was again repeated for the Durom Cup
with a search of Zimmer Durom Cup undertaken.
This resulted in 86 citation of which 3 were relevant to
the question, they are titled: A retrieval analysis of
explanted Durom metal-on-metal hip arthroplasties
(Matthies, 2011), Metal-on-Metal Total Hip
Arthroplasty: Causes and High Incidence of Early
Failure (Fabi, 2012) and Micro-structural alterations
within different areas of articulating surfaces of a
metal-on-metal hip resurfacing system (Pourzal, 2009).
Quality Criteria High Moderate Low
Prospective Design Prospective Prospective Retrospective

Number of Cases > 100 50 - 100 < 50
Ascertainment of
Outcome
Follow-up of at least 5
years
Follow-up of at least 3
years
Follow-up of < 3 years
Blind Study Double Blind Blind No
Association Positive No Association Negative

Table 1: Description of Quality Assessment of studies of Clinical Performance of Medical Devices (Khan,
2003)
Study Device Prospective Design Number of cases Ascertainment of Outcome Blind Study Association
(Herrera, 2013) ABG II High High High Moderate High
(Wal, 2008) ABG II Moderate Moderate High Moderate High
(Gracia, 2010) ABG II High High Moderate Low High
(Nourissat, 2013) ABG II Low Moderate High Moderate High
(Matthies, 2011) Durom Cup Low High Low Moderate Low
(Pourzal, 2009) Durom Cup Low Low Low Moderate Moderate
(Fabi, 2012) Durom Cup Low Moderate Moderate Moderate Low
(Mesko, 2009) Pinnacle High Low Moderate Low High
(Kindsfater, 2012) Pinnacle High Moderate High Moderate High
(Powers, 2010) Pinnacle High Moderate High High Moderate
(Squire, 2006) Pinnacle Moderate Low Moderate Moderate Moderate
(Mayer, 2012) Pinnacle Low Low Moderate Low Low
(Jameson, 2013) Pinnacle Low High Low Moderate High

Table 2: Results of the Quality Assessment of the Clinical Performance of Medical Devices



ASSESSING STUDY QUALITY
In order for the publications to be critically reviewed, a
study selection criteria should be devised. This should
outline the minimum acceptable level of design and
subject the studies to a more refined assessment through
a design based quality checklist. The objective of the
studies was to compare the clinical evidence of the
medical devices, without bias. Thus, the evidence is
more likely to be more accurate if the study was
prospective rather than retrospective. Secondly, the
results are more likely to be accurate if they study
ascertained a long follow up period and if the patient
assessment was achieved through a blind study (Khan,
2003). Lastly, the results of the study can be described
as either having a positive association (positive
evidence in relation to the clinical performance),
negative association or no association. The criteria used
to compare the studies and the quality levels can be seen
in table 1.

SUMMARIZING THE EVIDENCE
Through examination of the results in table 2, it can be
seen that the clinical performance of the ABG II
Femoral Stem, Pinnacle Hip Implant and the Durom
Cup is assessed in 13 studies. Of the 4 studies on the
ABG II Femoral Stem, it was found that all 4 showed a
positive association. Of the 6 studies on the Pinnacle
Hip Implant, it was found that 3 showed a positive
association, 1 showed a negative association and 2
showed no association. For the 3 studies on the Durom
Cup, 2 showed a negative association, while 1 showed
no association. Therefore, based upon the results of the
studies, we can make an assessment of whether there is
an association between the clinical performances of the
three medical devices.
The ABG II Femoral Stem showed a positive
association of the clinical performance of the device.
Secondly, the Pinnacle Hip Implant showed no clear
association in regard to the clinical performance. Lastly,
the Durom Cup showed an overall negative association
of the clinical performance.



INTERPRETING THE FINDINGS
The findings presented previously, must be interpreted
with caution due to the moderate/low quality of the
studies. However, due to the strategies in searching for
studies, some safeguard against missing relevant studies
can be taken. Thus the evidence presented in this
investigation can be presumed to be as accurate as
possible. Even though the interpretation of the results
may be limited due to the high number of low studies,
the findings are supported by the by the moderate-
quality studies (Khan, 2003).

CONCLUSION
Based upon the findings presented, we are able to come
to the conclusion that each devices has a varying level
of clinical performance. The Stryker ABG II Femoral
Stem showed a positive association in the studies
analysed. This is in contrast to the Zimmer Durom Cup
that has a negative association. Lastly, the DePuy
Pinnacle Hip Implant showed no clear association in
regard to the clinical performance. However, it should
be noted that due to the number of studies analysed, the
results may not reflect on the true clinical performance
of the device. This could be improved by analysing
further studies.




References
Fabi, D., 2012. Metal-on-Metal Total Hip
Arthroplasty: Causes and High Incidence of Early
Failure. Healio Orthopedics, 35(7), pp. 1009-1016.
Gorsky, A., 2013. DePuy Synthes. [Online]
Available at: http://www.depuy.com/about-depuy
[Accessed 03 09 2013].
Gracia, L., 2010. Study of bone remodeling of two
models of femoral Cementless stems by means of
DEXA and finite elements. BioMedical Eningeering
OnLine, 22(9), pp. 1-13.
Herrera, A., 2013. Long-Term Outcomes of a New
Model of Anatomical Hydroxyapatite-Coated Hip
Prosthesis. The Journal of Arthroplasty, 28(1), pp.
1160-1166.
Jameson, S., 2013. Independent predictors of
failure up to 7.5 years after 35 386 single-brand
Cementless total hip replacements. The Bone and
Joint Journal, 95(B), pp. 747-757.
Khan, K., 2003. Five steps to conducting a
systematic review. Journal of the Royal Society of
Medicine, Volume 96, pp. 118-121.
Kindsfater, K., 2012. Minimum 5-Year Results of
Modular Metal-On-Metal Total Hip Arthroplasty.
The Journal of Arthroplasty, 27(4), pp. 545-550.
Lobo, K., 1998. Stryker Australia. [Online]
Available at:
http://www.stryker.com/au/index.htm
[Accessed 2 September 2013].
Matthies, A., 2011. A retrieval analysis of
explanted Durom metal-on-metal hip
arthroplasties. Wichtig Editore, 21(6), pp. 724-731.
Mayer, S. W., 2012. Late Liner Disassociation of a
Pinnacle System Acetabular Component. Journal
of Arthroplasty, 35(4), pp. 561-565.
Mesko, J. W., 2009. Acute Liner Disassociation of a
Pinnacle Acetabular Component. The Journal of
Arthroplasty, 24(5), pp. 815-818.
Moynihan, R., 2007. Improve Population Health:
The Uses of Systematic Reviews. Milbank
Memorial Fund.
Nourissat, C., 2013. The Cementless Anatomic
Benoist Girard (ABG) II Total Hip Arthroplasty A
Minimum 8-Year Follow-Up Study. The Journal of
Arthroplasty, 28(1), pp. 707-711.
Pourzal, R., 2009. Micro-structural alterations
within different areas of articulating surfaces of a
metal-on-metal hip resurfacing system. Elsevier,
267(1), pp. 689-694.
Powers, C., 2010. A Comparison of a Second and
Third-Generation Modular Cup Design. The
Journal of Arthroplasty, 25(4), pp. 514-521.
Squire, M., 2006. Acetabular Component
Deformation with Press-Fit Fixation. The Journal of
Arthroplasty, 21(6), pp. 72-77.
Wal, B. C. H. v. d., 2008. Femoral fit in ABG-II hip
stems, influence on clinical outcome and bone
remodeling: a radiographic study. Arch Orthop
Trauma Surg , 128(1), pp. 1065-1072.