Prosthetic hip-associated cobalt toxicity: a systematic review of case series and case reports.

Prosthetic hip-associated cobalt toxicity (PHACT) is caused by elevated blood cobalt concentrations after hip arthroplasty. The aim of this study is to determine which symptoms are reported most frequently and in what type of bearing. We also try to determine the blood level of cobalt concentrations associated with toxicological symptoms. A systematic review was conducted on the 10th of July according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A methodological quality assessment (risk of bias (RoB)) was performed. Primary outcomes were the reported symptoms of cobalt toxicity and the level of cobalt concentrations in blood. These levels were associated with toxicological symptoms. A total of 7645 references were found of which 67 relevant reports describing 79 patients. The two most used bearings in which PHACT was described were metal-on-metal (MoM) bearings (38 cases) and revised (fractured) ceramic-on-ceramic (CoC) bearings where the former ceramic head was replaced by a metal head (32 cases). Of all reported symptoms, most were seen in the neurological system, of which 24% were in the sensory system and 19.3% were in central/peripheral system, followed by the cardiovascular (22.1%) system. The mean cobalt concentration for MoM-bearings was 123.7 ± 96.8 ppb and 1078.2 ± 1267.5 ppb for the revised fractured CoC-bearings. We recommend not to use a metal-based articulation in the revision of a fractured CoC bearing and suggest close follow-up with yearly blood cobalt concentration controls in patients with a MoM bearing or a revised fractured CoC bearing. Level of Evidence: Level V, systematic review.

No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial.

BACKGROUND: Computer Assisted Surgery (CAS) has proven to improve the accuracy in several orthopedic procedures. Therefore we used this technique to evaluate femoral component positioning in Hip Resurfacing Arthroplasty (HRA). The aim of this study was to evaluate imageless CAS compared to manually implanted femoral components and subsequently evaluates Patient Related Outcome Measures (PROMs). We hypothesized that the use of CAS optimizes the position of the femoral component and improves PROMs. METHODS: This is a multicenter, single-blinded, randomized, controlled trial of two groups. In the CAS group guiding of the femoral component was done with imageless navigation. In the Conventional (control) group the femoral component was placed manually according to the preplanned position. The primary outcome measure consists of a maximum of 3 degrees difference between the postoperative Stem Shaft Angle (SSA) and preplanned SSA. Secondary outcome measures consist of the Hip disability and Osteoarthritis Outcome Scale (HOOS), the Harris Hip Score (HHS) and Visual Analogue Scale (VAS) pain score. RESULTS: A total of 122 patients were randomized, 61 in the CAS group and 61 in the conventional group. There was no significant differences in accuracy of femoral implant position. The mean difference between the postoperative- and preplanned SSA was - 2.26 and - 1.75 degrees (more varus) respectively in the CAS and Conventional group. After surgery both groups show significant improvement in all PROMs compared to the baseline measurements, with no significant differences between the groups. CONCLUSION: Our cohort indicates no benefit for the use of CAS in accuracy of placement of the femoral component in HRA compared to manual implantation. There are no clinical differences in PROMs after 1 year follow up. This study showed no added value and no justification for the use of CAS in femoral component positioning in HRA. TRIAL REGISTRATION: This trial is registered at ClinicalTrails.gov ( https://clinicaltrials.gov/ ) on the 25th of October 2006: NCT00391937. LEVEL OF INCIDENCE: Level IIb, multicenter randomized controlled trial.

Clinical and Wear Analyses of 9 Large Metal-on-Metal Total Hip Prostheses.

BACKGROUND: Metal-on-Metal (MoM) total hip arthroplasties (THA) are associated with pseudotumor formation and high revision rates. This prospective study analysed the clinical and wear analyses of 9 large Metal-on-Metal (MoM) total hip arthroplasties (THA) to understand the underlying mechanisms of failure. The MoM bearings were revised for multiple reasons; the main reason was pseudotumor formation. MATERIALS AND METHODS: From 2006 till 2010 the Reinier de Graaf Hospital implanted 160 large head M2a-Magnum™ (Biomet Inc. Warsaw, Indiana, USA) THAs in 150 patients. The first year, 9 bearings were revised and analysed at the Biomechanics Section, Hamburg University of Technology, Germany. We performed clinical (Harris Hip Score, radiographic analysis, blood cobalt and chromium) and wear analysis (implant, tissue and fluid) of the 9 bearings. Since this study did not fall under the scope of the Medical Research Involving Human Subjects Act in The Netherlands, no ethical approval was necessary. In this prospective study all patient details were anonymized by the corresponding author, all other authors were blinded during the research and wear analyses. Patients with bilateral MoM implants were excluded. RESULTS: The 9 bearings had a median (IQR) survival of 41.0 (25) months in situ. From these bearings, three showed no noticeable wear. The median (IQR) head wear volume was 3.2 (3.6) mm3 and maximum wear depth 0.02 (0.02) mm. For the cup the median (IQR) wear volume was 0.23 (0.3) mm3 with a maximum wear depth of 0.03 (0.05) mm. CONCLUSION: An early identification of parameters related to failure of the MoM THA, such as pain, decreased range of motion, radiographic changes and high levels of blood cobalt and chromium is of great importance for patient's quality of life. Especially now patients and surgeons face the long term effects of all these bearings still in situ. This study reports the clinical and wear analyses of 9 MoM THA. In the majority of this group the reason for revision was pseudotumor formation. Most bearings showed signs of wear, however with a great diversity in clinical analysis, in inclination angle, serum cobalt and chromium levels as well as wear analysis. For a better understanding of the underlying mechanisms related with failure, more wear analyses of revised MoM bearings are necessary as well as a frequent follow-up of the patients with a MoM bearing.

Severe Wear and Pseudotumor Formation Due to Taper Mismatch in a Total Hip Arthroplasty: A Case Report.

CASE: We describe the case of a seventy-six-year-old woman who had undergone bilateral total hip arthroplasty with Zweymüller-Metasul prostheses in 1996. After a fall sixteen years after the index procedures, radiographs suggested a taper fracture of the left total hip arthroplasty. However, revision surgery showed pseudotumor formation, with no evidence of taper fracture. Analysis of the prosthesis showed massive wear of the male stem taper caused by a mismatch between the stem taper and the head taper. CONCLUSION: This case vividly demonstrates how taper size mismatch can cause dramatic metal wear and increased release of metal ions, resulting in pseudotumor formation.