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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

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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
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    T his 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 w ere 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.

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Jul 23, 2017

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Jul 23, 2017
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