To prospectively assess the safety, efficacy and patient satisfaction of a standardised perioperative anesthetic and pain management protocol for outpatient Total Ankle Arthroplasty. Starting February 2008 we chose to enrol 50 consecutive patients undergoing Total Ankle Arthroplasty in this study. All patients were assesed and treated by a single Anesthesiologist and Orthopedic surgeon. All patients received preoperative dosing of Celebrex, Oxycontin and Gabapentin. Anesthesia consisted of a popliteal regional block and a spinal anesthetic. Patients were discharged home when they were stable with adequate pain control and able to ambulate with crutches or a walker. All patients were contacted by telephone by the treating Anesthesiologist to assess for pain control, complications and satisfaction on the night of surgery and for the next two days. Patients were also given contact numbers to call the Anesthesiologist for any concerns outside of these times. All patients were assessed by the treating Orthopedic surgeon at two and six weeks post surgery with data collected regarding wound complications, infection, deep venous thrombosis and overall patient satisfaction.Purpose
Method
The purpose of this study was to compare the clinical outcome of patients treated surgically for end stage ankle arthritis using a total ankle arthroplasty or ankle arthrodesis. This is a multicentered prospective clinical outcome study of the surgical treatment of patients with EAA using an ankle arthrodesis (n= 117) or total ankle arthroplasty (n= 210). Clinical outcome was assessed using health related quality of life (SF36v2) and joint specific (Foot Function Index, Ankle Osteoarthritis Scale, American Orthopedic Foot and Ankle Hindfoot Scale and the AAOS Foot and Ankle Baseline Questionnaire(version 2000)) outcome scores. Preoperatively, all patients had significant physical and psychological morbidity. All symptom and functional SF36 subscales were approximately two standard deviations below normal population scores. Approximately 25% of patients were three standard deviations below population values, indicating increased risk of mortality. There was no evidence that age or gender influenced the level of disability. There was a significant improvement in the health related quality of life and the joint specific clinical outcome scores at six and twelve months follow up but no consistent difference was noted between the two cohorts. This is the first multicentered prospective clinical outcome study that demonstrates equal efficacy for early follow up of patients treated for EAA with total ankle arthroplasty or ankle arthrodesis.
This phase III, multicenter, double-blind placebo controlled study evaluated safety and efficacy of aprotinin in reducing blood transfusion in subjects undergoing THA. Subjects were stratified by preoperative autologous blood donation and randomized to receive aprotinin (1 mL test dose; load, 2 million KIU and 0.5 million KIU/hour) or placebo. Subjects were assessed at baseline, postoperative days 1, 2, 3, 7 (or discharge) and 6±2 weeks. Primary efficacy variable was percentage of subjects requiring blood transfusion through day 7 or discharge. Safety was based on adverse event (AE). Of 359 randomized subjects, 175 in each group completed the study. Demographics of the groups were similar. Aprotinin reduced by 46% the requirement for any transfusion (17% vs 32% of subjects, p=0.0009). Aprotinin reduced allogeneic blood transfusion in subjects regardless of predonation status (11% vs 22%, p=0.0063), who made no predonation (13% vs 24%, p=0.0216), and who predonated (32% vs 62%, nd). The aprotinin group had a reduction of the number of any (48 vs 109 units; p=0.0003) and allogeneic (30 vs 72 units; p=0.0041) units transfused and total fluid loss (709 vs 957 ml; p=0.0002) compared with placebo. One patient died in the placebo group. AEs were reported in 83% of aprotinin-treated and 86% of placebo subjects, with 10% and 11%, respectively, described as serious AEs. No clinically important differences between aprotinin and placebo AEs were observed. Hypersensitivity to aprotinin was not reported. In this study, full-dose aprotinin was safe and effective in decreasing blood transfusion in subjects undergoing THA.
