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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 53 - 53
1 Feb 2017
Bragdon C Barr C Madanat R Nielsen C Bedair H
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Introduction

A modern total knee replacement system was introduced in 2012 in order to improve the mechanics of total knee replacement (TKR). The purpose of this study was to assess the early clinical and radiographic outcomes of patients who have been treated with this modern TKR system at two years postoperatively.

Methods

Patients who received this TKR system between June of 2012 and September of 2014 were included in this prospective registry-based follow-up study. Demographics, component, and surgical data were collected. Radiographic outcomes were also assessed. Patient reported outcome measures (PROMs) of all patients with 2-year follow-up data were collected. Reasons for revision and overall survival at 2-years were evaluated.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 99 - 99
1 Feb 2017
Bragdon C Hussey D Madanat R Donahue G Rolfson O Muratoglu O Malchau H
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Introduction

When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines.

The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system.

Methods

The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 100 - 100
1 Feb 2017
Bragdon C Donahue G Lindgren V Galea V Madanat R Muratoglu O Malchau H
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Introduction

Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA.

The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA.

Methods

The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 128 - 128
1 Feb 2017
Bragdon C Galea V Donahue G Lindgren V Troelsen A Marega L Muratoglu O Malchau H
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Introduction

Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable.

The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards.

Methods

We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 34 - 34
1 Feb 2017
Bragdon C Barr C Nebergall A Rolfson O Troelsen A Rubash H Malchau H Greene M
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Introduction

In vitro studies showed that the anti-oxidative properties of vitamin E stabilize free radicals while retaining the mechanical strength of UHMWPE. The purpose was to evaluate vitamin E diffused polyethylene (VEPE) wear and stability of femoral components using RSA. Patient reported outcome measures (PROMs) were evaluated to determine the clinical outcome at 5 years.

Methods

48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 51 - 51
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction

The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998 and femoral heads larger than 32mm in diameter introduced 2004.

The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against large diameter femoral heads at a minimum of 10 years follow-up.

Methods

Two centers contributed patients to this ongoing clinical study. Inclusion criteria for patients was: primary THR; femoral heads greater than 32mm; minimum 10 year follow-up. 69 hips have been enrolled with an average follow-up of 11.2 years (10–15), 32 females (50%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 52 - 52
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction

The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998. Numerous publications have reported reduced wear rates and a reduction in particle induced peri-prosthetic osteolysis at short to mid-term follow-up.

The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against 32mm femoral heads or less at a minimum of 13 years follow-up.

Methods

Inclusion criteria for patients was a primary THR with femoral heads 32mm or less and a minimum 13 year follow-up. 139 hips have been enrolled with an average follow-up of 13.7 years (13–16), 80 females (57%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 158 - 158
1 May 2016
Graves S Lorimer M Bragdon C Muratoglu O Malchau H
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Introduction

Infection remains a serious complication following primary total hip arthroplasty (THA). Many factors including primary diagnosis, comorbidities and duration of procedure are known to influence the rate of infection. Although the association between patient and surgical factors is increasingly well understood, little is known about the role of the prosthesis. This analysis from the Australian Registry (AOANJRR) was undertaken to determine if revision for infection varied depending on the type of bearing surface used.

Methods

Three different bearing surfaces, ceramic on ceramic (CoC), ceramic on cross-linked polyethylene (CoXP) and metal on cross-linked polyethylene (MoXP) were compared. The study population included all primary THA undertaken for OA using these bearing surfaces and reported to the AOANJRR between 1999 and 2013. Kaplan-Meier survivorship curves were compiled with revision for infection as the end point. Hazard Ratios (HR) from Cox proportional hazards models were used to compare revision rates. Sub analysis examining the effect of age, gender, fixation of the femoral stem and femoral head size. To ensure there was no confounding due to differences in femoral and acetabular component selection a further analysis was undertaken which compared the three different bearings with the same stem and acetabular component combinations.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_19 | Pages 30 - 30
1 Dec 2014
Nortje M Hussey D McLennan-Smith R Dymond I Grobler G Dower B Bragdon C Muratoglu O Malchau H
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Introduction:

The ASR™ Articular Surface Replacement and ASR™ XL Metal-on-Metal systems were recalled due to high revision rates at five years. A worldwide clinical follow-up of patients was initiated. This paper summarizes current findings in South Africa (SA) in comparison with those outside SA (OSA).

Methods:

Patients were followed annually, or until revision, from 10 clinical centers worldwide. Data collected includes demographic, surgical, radiographic, blood metal ion levels, and patient reported outcome measures (PROM).