The ceramic coated implant (CCI). Evolution total ankle replacements: a retrospective analysis of 40 ankles with 8 years follow-up.

Diminutive data is available on the outcome of several previously used total ankle replacement implants. The purpose of this study was to investigate the medium-term functional and radiological outcome and implant survival of the CCI Evolution implant. Consecutive series of 40 ankles operated in our hospital with primary TAR using the CCI Evolution implant in 2010-2013 were available for follow-up. The prospective clinical and radiographic data including the Kofoed score, subjective satisfaction and standard radiographs were collected preoperatively and at fixed time-points postoperatively. A CT was obtained in cases where osteolysis or loosening were suspected. The improvement of the Kofoed score and subjective satisfaction were statistically significant (p<0.0001). The implant survival was 97% (95% confidence interval (CI) 81%-100 %) at 5 years, and 81 % (95% confidence interval (CI) 60 %-92%) at 8 years. There were altogether 25 (64%) complications. Overall revision rate was 28% and failure rate 13%. The CCI implant outcome was not acceptable. The malposition of prosthetic components, subsidence, and peri-implant osteolysis were recorded often. Although the patient reported outcome measures improved, mostly due to positive changes in pain severity, overall revision and failure rates were high and comparable with previous findings of the CCI implant.

RANKL in the osteolysis of AES total ankle replacement implants.

Peri-implant tissue reactions in failed total ankle replacement (TAR) are characterized by early developing peri-implant osteolysis. The hypothesis of the study was that this reaction is mediated by receptor activator of nuclear factor kappa B ligand (RANKL). Samples of peri-prosthetic tissues from failed TAR implants were stained for macrophages, RANKL, its receptor RANK and osteoprotegerin (OPG), and compared to control samples. The failed TAR implants were surrounded by implant capsule, synovial lining-like interface membrane or necrotic tissues. Infiltrating scavenger receptor I positive CD163(+) macrophages were frequent, in particular around necrotic soft tissues or bone sequestrate, and possibly in part formed due to ischemia and mechanical factors. In contrast, implant-derived wear debris was scanty. Still many RANK(+) macrophages were often seen in close contact with RANKL(+) mesenchymal cells, whereas OPG was mostly located at a distance in vascular endothelial cells. Foreign body giant cells were frequent. RANKL seems to stimulate locally accumulated CD163(+) RANK-expressing cells to fusion, which leads to the local formation of multinuclear foreign body giant cells (and probably of osteoclasts). Therefore, peri-implant osteolysis in early TAR implant failure seems to be caused by the RANKL-driven chronic foreign body inflammation directed against, not implant-derived particles, but against necrotic autologous tissues.

Severe periprosthetic osteolytic lesions after the Ankle Evolutive System total ankle replacement.

Between 2002 and 2008, 130 consecutive ankles were replaced with an hydroxyapatite (HA) and titanium-HA-coated Ankle Evolutive System total ankle prosthesis. Plain radiographs were analysed by two independent observers. Osteolytic lesions were classified by their size and location, with cavities > 10 mm in diameter considered to be 'marked'. CT scanning was undertaken in all patients with marked osteolysis seen on the plain radiographs. Osteolytic lesions were seen on the plain films in 48 (37%) and marked lesions in 27 (21%) ankles. The risk for osteolysis was found to be 3.1 (95% confidence interval 1.6 to 5.9) times higher with implants with Ti-HA porous coating. Care should be taken with ankle arthroplasty until more is known about the reasons for these severe osteolyses.

Anaesthesia with remifentanil infusion in diabetic versus non-diabetic patients undergoing vitrectomy. A Holter-controlled study.

Diabetic patients are known to have additional risks in surgery. We evaluated haemodynamic profiles, incidence of arrhythmias and post-operative recovery when remifentanil infusion was used for vitrectomies. We compared 22 diabetics with 22 age-matched controls undergoing vitrectomy. ECG Holter monitoring was continued throughout the operation and until 20 hours postoperatively. Autonomic tests including breathing and stand up were performed in the beginning of Holter-monitoring. Anaesthesia was induced with a bolus of remifentanil (1 microg/kg) and continued with 0.4 microg/kg/ h. Thereafter, propofol, 0.5 mg/kg, was given with additional doses of 0.25 mg/kg if needed. Anaesthesia was maintained with 40% oxygen in air and 0.5% isoflurane. After the operation time to obey commands, pain scores, nausea and vomiting, and haemodynamic parameters were registered. Both breathing and stand up tests differed statistically between the groups (p = 0.001 and p = 0.000, respectively). Diabetic patients needed less remifentanil (p = 0.039) than controls. Hypotensive periods were more frequent in diabetic patients (p = 0.013) and they needed more etilefrine than controls (p = 0.014). Holter recordings revealed no ischaemic episodes in either group. Periods of short ventricular and supraventricular extra beats occurred without any clinical relevance in both groups. Time to obey commands or need for pain medicine postoperatively did not differ between the groups. Diabetic patients were haemodynamically more instable with more frequent hypotensive periods during anaesthesia despite of less amount of remifentanil compared to controls. On the other hand, during remifentanil infusion no ischaemic or clinically significant arrhythmic episodes occurred in either group.

Evaluation of the M37 human rotavirus vaccine in 2- to 6-month-old infants.

Human rotavirus strain M37, isolated from an asymptomatic neonate, was evaluated as a live oral vaccine in a double-blinded, placebo-controlled trial involving 282 infants ages 2 to 6 months. Either 10(4) or 10(5) plaque-forming units (PFU) of the M37 vaccine were tested in 102 and 39 infants, respectively. The vaccine was well-tolerated; fever on Days 1 to 7 after vaccination was recorded in 12 and 18% of infants receiving 10(4) and 10(5) PFU of the M37 vaccine, respectively, compared with 6% of those receiving placebo; none of the vaccinees developed diarrhea. A rotavirus IgA enzyme-linked immunosorbent assay serum antibody response was detected in 47 and 76% of the infants receiving the 10(4) and 10(5) PFU vaccines, respectively. No clinical protection against rotavirus diarrhea was observed in the group vaccinated with the 10(4) PFU dose; the number of infants vaccinated with 10(5) PFU was too small for evaluation of vaccine efficacy. The M37 vaccine in a titer of 10(4) PFU was found to be inadequate; the 10(5) PFU dose was more immunogenic than the lower dose and warrants further study for clinical efficacy.