The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions.Aims
Methods
The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either We examined 11 retrieved 3D printed acetabular cups divided into two groups: “Introduction
Material and methods
Metal-on-metal (MOM) total hip arthroplasty using large diameter femoral heads offer clinical advantages however the failure rates of these hips is unacceptably high. Retrieved hips have a wide range of wear rates of their bearing and taper surfaces and there is no agreement regarding the cause of failure. Detailed visual inspection is the first step in the forensic examination of failed hip components and may help explain the mechanisms of failure. The aim of this study was to determine if there was a correlation between the results of detailed inspections and the volumetric wear of the bearing and taper surfaces of retrieved hips. Detailed, non-destructive macroscopic and stereomicroscopic examinations of 89 retrieved MOM hip components were performed by a single experienced examiner using quantitative assessment to document the severity of 10 established damage features: Light scratches, Moderate scratches, Heavy scratches, Embedded particles, Discolouration, Haziness, Pitting, Visible wear zone, Corrosion, Fretting Each surface was considered in terms of zones comprising of quadrants (cup, head, and taper) and subquadrants (cup and head), Figure 1. Each zone was scored on a scale of 0 to 3 by determining the percentage of the surface area of the zone that exhibited the feature in question: a score of 0=0%, 1<25%, 25%<2<75%, 3>75%. The sum of the scores of each zone was used for the assessment of each damage feature. The volume of wear at the surfaces of each hip was measured with a Zeiss Prismo coordinate measuring machine (cup and head) and a Talyrond 365 roundness measurement instrument (taper), using previously reported methods1, 2. Simple linear regression models were used to asses the univariable associations between the inspection scores and wear volumes. Multiple linear regression models were subsequently used to asses the simultaneous contribution of the inspection scores, found significant in univariable analyses, on the wear outcome variables. All statistical analysis was performed using Stata/IC version 12.1 (StataCorp, USA) and throughout a p value < 0.05 was considered statistically significant.Introduction
Method
It has been suggested that corrosion and fretting at the taper junctions of stemmed metal-on-metal hip replacements may contribute to their high failure rates. A peer-reviewed semi-quantitative scoring system [Goldberg et al., 2002] has been used to visually assess the severity of corrosion and fretting of the taper junction but has not been validated using multiple examiners. The aim of this study was to assess the inter-observer variability of this method. Macroscopic and stereomicroscopic examinations of the femoral head and stem tapers of 100 retrieved large diameter metal on metal (MOM) hip components were performed by two independent observers using the methods defined by Goldberg et al. [2002] to quantify corrosion and fretting. Scores ranging from 1 (none) to 4 (severe) were assigned to the medial, lateral, posterior and anterior quadrants of the neck taper and the distal and proximal regions of the head taper. An overall score was then assigned to each surface as a whole. Cohen's weighted Kappa statistic (κ) was used to measure the inter-observer agreement. A quadratic weighting scheme, that allocated weights to the importance of disagreements that are proportional to the square of the number of categories apart, was used to take account of scaled disagreement. Kappa values were assessed using previously established criteria where κ ≤ 0 = poor, 0.01 to 0.20 = slight, 0.21 to 0.40 = fair, 0.41 to 0.60 = moderate, 0.61 to 0.80 = substantial, 0.81 to 1 = almost perfect. A sample size of 100 was used in order to detect a coefficient of 0.60 to within 0.25 with 95% confidence with two experienced observers. Statistical analysis was performed using Stata/IC version 12.1 (StataCorp, College Station, TC, USA) and a p value < 0.05 was considered statistically significant.Introduction
Method
Metal-on-metal (MOM) total hip arthroplasty and hip resurfacing using large diameter femoral heads offer clinical advantages, however the failure rates of these hips are unacceptably high. Retrieved MOM hips have a wide range of wear rates of their bearing surfaces and there is ongoing research to identify the causes of failure. Detailed visual inspection is the first step in the forensic examination of failed hip components, but there is no universally accepted description or process. Visible features may help explain the mechanism of failure of MOM hips. During our analysis of 2000 MOM hip components, we have developed protocols to undertake detailed, non-destructive macroscopic and stereomicroscopic examinations of each component, using quantitative assessment to document the presence of types of damage. We have established a systematic terminology to describe the types of damage that are observed, allowing for consistency and clarity in the vocabulary used. These include (but are not limited to):
Scratching – when there is an increase in the number and/or magnitude of scratches present on the surface, typically increasing measured roughness parameters. The severity of scratching is determined by rubbing a 0.18 mm thickness acetate gage or fingernail over the surface:
Light –visible but not detectable with gage. Moderate – visible and detectable with gage. Heavy – depth clearly visible and will catch a fingernail or gage. Pitting – indentations in the surface for which the dimensions are similar in all directions. Embedded Particles – hard particles that have become embedded in the bearing surface. Discolouration – observed as a change in the appearance of the surface, often as colour diffraction patterns. Polishing, gouges, etching (from corrosion), surface films, surface deposits and tribochemical reaction layers. To assess the distribution of these types of damage on the components, each surface is considered in terms of zones defined by quadrants (cup, head, stem and taper) and sub-quadrants (cup and head only), Figure 1. Each zone is scored on a scale of 0 to 3 by determining the percentage of the surface area of the quadrant that exhibits the feature in question:
a score of 0 indicates 0%
indicates greater than 0% but less than 25% indicates between 25% and 75% inclusive indicates greater than 75%. The use of zones to differentiate between the polar and equatorial regions of the cup and head surfaces can offer important information relating to the articulation of the bearing surfaces. For example in a cohort of 90 inspections, a score of 3 for light scratching was recorded in all areas of the bearing surface in 40% of cups, whilst approximately 5% had evidence of pitting, occurring near the rim. Current research at our retrieval centre involves correlating the results of detailed inspections with a range of variables, including implant design, size and surgical position.
