A Systematic Review of the Clinical Performance of the Stryker AB II Femoral Stem, DePuy Pinnacle Hip Implant and the Zimmer Durom Cup

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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 publishedevidence 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 HighTable 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 cometo 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.



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A Systematic Review of the Clinical Performance of the Stryker AB II Femoral Stem, DePuy Pinnacle Hip Implant and the Zimmer Durom Cup