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1.
Hip Int ; 30(6): 761-774, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32933331

ABSTRACT

BACKGROUND: The major joint registries report better survivorship for ceramic on polyethylene over metal on polyethylene bearings in total hip arthroplasty and it is generally accepted that this is due to a lower polyethylene wear rate. We used evidence synthesis to compare survivorship, polyethylene wear rates and metal ion levels for metal-on-polyethylene (MoP) and ceramic-on-polyethylene (CoP) bearings. If wear rates are not dissimilar in vivo this difference in revision rate may have another cause. Modular junctions are a potential source of corrosion and it is postulated that this may result in higher revision rates. METHODS: We performed a systematic review and meta-analysis comparing the survivorship of MoP and CoP bearings. Odds ratio (95% CI) of revision was calculated. Mean difference (MD) and 95% confidence intervals (CI) were used to compare secondary outcomes of polyethylene wear and metal ion levels. Meta-analysis was performed with a Mantel-Haenszel Random-Effects Model. RESULTS: 6 randomised controlled trials were included. There was no statistically significant difference between MoP and CoP revision rate (OR 1.04; 95% CI, 0.37-2.90, I2 = 0%, p = 0.94), linear bearing wear (MD 0.00 mm; 95% CI, -0.05 -0.05, I2 = 98%, p = 0.90), nor volumetric bearing wear (MD 33.57 mm3; 95% CI, -215.56-282.70, I2 = 98%, p = 0.79). No studies evaluated metal ion levels. CONCLUSIONS: We found no evidence of a difference in revision rates nor linear and volumetric wear between MoP and CoP bearings in the randomised controlled trials currently available. Our study therefore does not advocate the additional cost associated with the use of ceramic heads in combination with polyethylene bearings in order to minimise revision rates. This contrasts the findings of in vitro studies and the major joint registries.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Ceramics , Hip Prosthesis , Polyethylene , Registries , Humans , Prosthesis Design , Prosthesis Failure , Reoperation , Risk Factors
2.
Curr Pharm Anal ; 9(4): 331-339, 2013.
Article in English | MEDLINE | ID: mdl-25110470

ABSTRACT

Analysis of n3 fatty acids in serum samples has clinical applications in supplementation trials, but the analysis can be challenging due to low levels, stability issues and intra-individual variation. This study presents the single laboratory validation of a gas chromatographic-mass spectral (GC-MS) assay for analysis of fatty acid methyl esters (FAME) using sensitive single ion monitoring and provides data on fatty acid stability under different sample handling conditions. Recovery of total fatty acids from serum with Folch extraction was optimized and parallelism tests with spiked samples indicated that the serum matrix did not interfere with mass spectral quantitation. Precision and accuracy of the assay at the lowest limit of quantitation and at low, medium and high levels met with accepted guidelines for single laboratory validation. Several storage conditions that can be encountered with clinical samples also were evaluated for impact on fatty acid levels in serum. Serum from blood that was stored refrigerated for 3 days yielded similar results as serum that was prepared and frozen at -80°C immediately. Serum storage at room temperature for 3-24 hours and serum subjected to one freeze/thaw cycle had minimal effects on fatty acid levels. The intra-individual variability in pregnant women was reasonably small, with significant correlation coefficients ranging from 0.35 to 0.76 for blood drawn between 12-20 weeks versus 34-36 weeks of gestation. These results indicate that GC-MS with single ion monitoring is valid for the analysis of total fatty acids in clinical samples, even when blood processing cannot be performed in a timely manner.

3.
Contemp Clin Trials ; 33(5): 881-8, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22640923

ABSTRACT

This study recruited persons at increased risk of colon cancer to an intensive dietary intervention study that required biopsies of the colon by flexible sigmoidoscopy at baseline and after six months of intervention. A total of 1314 individuals contacted the study, and only 16 individuals indicated that the sigmoidoscopy procedure was an obstacle to study participation. A total of 270 individuals completed a screening visit and signed a screening consent form. Inquiries about the study tended to be fewer in the winter and late summer. Failure to return food records was the most common reason for exclusion. Dietary recall at enrollment indicated that subjects were consuming significantly more vegetables, lower sodium and a lower glycemic load on the day before starting the study vs. during the eligibility phase which might have an impact on biomarker measures. This makes it important to capture dietary changes in the period between determination of eligibility and enrollment. Subjects (n=120) were randomized to follow a Healthy Eating or a Mediterranean Diet, each of which required substantial dietary record-keeping. The study completion rate was 78%, and subjects reported high satisfaction with study participation. Of the 93 individuals who completed the study, only one refused the flexible sigmoidoscopy at the final visit. These findings suggest that flexible sigmoidoscopy does not appear to be a barrier for recruitment of high-risk individuals to an intensive dietary intervention trial, but that completing food records can be.


Subject(s)
Biopsy/methods , Colonic Neoplasms/prevention & control , Diet, Mediterranean , Diet/methods , Patient Dropouts/statistics & numerical data , Patient Selection , Adult , Aged , Aged, 80 and over , Biopsy/statistics & numerical data , Colonic Neoplasms/diagnosis , Colonic Neoplasms/epidemiology , Diet Records , Female , Humans , Male , Middle Aged , Patient Satisfaction , Risk Factors , Seasons , Sigmoidoscopy
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