Dataset Information

Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.

ABSTRACT:

Background

Femoral stem fracture following total hip arthroplasty is an uncommon event that requires immediate revision surgery.

Questions/purposes

We report on four patients who experienced stem fractures of one design and a review of the US Food and Drug Administration adverse event reports on this design.

Methods

Fracture surfaces of four EMPERION™ (Smith & Nephew, Memphis, TN) femoral stems were analyzed under optical and scanning electron microscopy. A search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) that reports on all EMPERION™ adverse events was completed.

Results

Fracture surfaces exhibited characteristics consistent with a fatigue fracture mechanism. Sixteen MAUDE reports claimed stem fracture or breakage of EMPERION™ stems.

Conclusion

The four cases of EMPERION™ stem fractures were likely driven by small stem diameter, high offset, and high patient weight. Modular stem-sleeve femoral systems are susceptible to fatigue failure under high stress and should only be used in appropriate patients, whom are not considered obese.

SUBMITTER: Koch CN

PROVIDER: S-EPMC5026663 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Publications

Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.

Koch Chelsea N CN Mateo Laura Serrano LS Kayiaros Stephen S Cassidy Kevin A KA Jerabek Seth A SA Gonzalez Della Valle Alejandro A

HSS journal : the musculoskeletal journal of Hospital for Special Surgery 20160621 3

<h4>Background</h4>Femoral stem fracture following total hip arthroplasty is an uncommon event that requires immediate revision surgery.<h4>Questions/purposes</h4>We report on four patients who experienced stem fractures of one design and a review of the US Food and Drug Administration adverse event reports on this design.<h4>Methods</h4>Fracture surfaces of four EMPERION™ (Smith & Nephew, Memphis, TN) femoral stems were analyzed under optical and scanning electron microscopy. A search of the FD ...[more]

PMID: 27703419

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Project description:BackgroundThe purpose of our study is to assess the methodology of overlapping systematic reviews related to cemented vs uncemented hip hemiarthroplasties for the treatment of femoral neck fractures to find the study with the best evidence. Also, we assess the gaps in methodology and information to help with direction of future studies.MethodsA systematic search was conducted in September 2022 using Pubmed, Embase, and Cochrane Library. Clinical outcome data and characteristics of each study were extracted to see which treatment had better favorability. The outcomes and characteristics extracted from each study includes, first author, search date, publication journal and date, number of studies included, databases, level of evidence, software used, subgroup analyses that were conducted, and heterogeneity with the use of I2 statistics Methodological quality information was extracted from each study using four different methodologic scores (Oxford Levels of Evidence; Assessment of Multiple Systematic Reviews (AMSTAR); Quality of reporting of meta-analyses (QUROM); Oxman and Guyatt. After that, the Jadad decision algorithm was used to identify which studies in our sample contained the best available evidence. Finally, overlap of each systematic review was assessed using Corrected Covered Area (CCA) to look at redundancy and research waste among the systematic reviews published on the topic.ResultsAfter screening, 12 studies were included in our sample. For the Oxford Levels of Evidence, we found that all the studies were Level I evidence. For the QUORUM assessment, we had 1 study with the highest score of 18. Additionally, we did the Oxman and Guyatt assessment, where we found 4 studies with a maximum score of 6. Finally, we did an AMSTAR assessment and found 2 studies with a score of 9. After conducting the methodological scores; the authors determined that Li. L et al 2021 had the highest quality. In addition, it was found that the CCA found among the primary studies in each systematic review calculated to .22. Any CCA above .15 is considered "very high overlap".ConclusionsThe best available evidence suggests that Cemented HAs are better at preventing Prosthesis-related complications. Conversely, the best evidence also suggests that Cemented HA also results in longer operative time and increased intraoperative blood loss. When conducting future systematic reviews related to the topic, we ask that authors restrict conducting another systematic review until new evidence emerges so as not to confuse the clinical decision-making of physicians.

Dataset Information

Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.

Background

Questions/purposes

Methods

Results

Conclusion

Publications

Spontaneous Fractures of a Modern Modular Uncemented Femoral Stem.

Similar Datasets

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