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.

Introduction: Although there is no absolute diagnostic test for PPI, synovial leukocyte counts and neutrophil percentages have been reported to have high sensitivity and specificity making them valuable tests for diagnosis. However, no cut off value for the latter is agreed upon. This study intends to evaluate to define definite cut-off values for preoperative synovial fluid leukocyte count and PMN percentage that allow physicians to diagnose infection in a prosthetic joint.

Methods: We analyzed synovial fluid aspirated preoperatively from 593 total knee arthroplasties (161 infected; 432 aseptic) from three different institutions. Using ROC curves, we determined cut-off values with optimal accuracy in diagnosis of infection for fluid leukocyte count and PMN percentage. The sensitivity, specificity, and predictive values were calculated for the above cutoff values.

Results: The synovial fluid leukocyte count was higher in patients with PPI (median, 31 × 103 cell/μl) compared to aseptic joint arthroplasties (median, 0.219 × 103 cells/μl)(p< 0.0001). Similarly, the neutrophil percentage was higher in patients with PPI (median, 90%) than in those with noninfected joints (median, 26%)(p< 0.0001). The cut-off values for optimal accuracy in diagnosis of infection were 1760 cells/μl for fluid leukocyte count and 73% for PMN percentage. A fluid cell count > 1760 cells/μl had a PPV of 99% and NPV of 88%, while a neutrophil percentage > 73% yielded a PPV of 96% and NPV of 91%. Chi-square analysis revealed the fluid WBC count and the neutrophil percentage to be significantly associated with the diagnosis of infection (p< 0.0001).

Discussion: Synovial fluid leukocyte count and differential are useful adjuncts to ESR and CRP in the preoperative diagnosis for infection in TKA. This study has identified a cut-off value for leukocyte count and neutrophil percentage that can be used to diagnose infection in a prosthetic joint.

Background: Total joint arthroplasty (TJA) is a successful procedure. With the demographic tendency towards an elderly society and a relatively high prevalence of arthritis, the number of joint replacement in the US will increase dramatically in the upcoming years. The orthopaedic surgeons need to be aware of the various types of complications in the early hospital setting associated with elective TJA.

Methods: This prospective study reviewed the systemic and local early complications occurring after 13133 TJA which included 7,438 hip arthroplasties (6,010 primary and 1,428 revisions) and 5,695 knee replacements (4,944 primary and 751 revisions). A standardized and detailed form intended to capture all medical and orthopedic complications was devised, plus a full-time research fellow was dedicated to this study. The hospital course of every patient was followed on a daily basis closely. The circumstances leading to the complications and the details of the therapeutic intervention for each complication were recorded.

Results: In general the incidences of complications were higher following TKA compared to THA. There was 26(0.19%) deaths in the cohort that occurred within 10 days after surgery. 329 major (life threatening) complications occurred in the cohort that included myocardial infarction (36), hypotensive crisis (11), pulmonary embolus (145), tachyarrhythmia (93), pulmonary edema (10), acute renal failure (24), stroke (6), bowel obstruction or perforation (3), and pneumothroax (1). There were 37 major local complications. 301 (91%) of these complications occurred within 4 days of index surgery. There were 453 minor systemic complications, mostly related to anemia, and 99 minor local complications in this cohort.

Conclusions: Total joint arthroplasty despite its success can be associated with serious and life threatening complications. The introduction of MIS surgery and the potential for very early discharge of patients undergoing arthroplasty needs to be scrutinized in light of these findings.

Introduction: Management of bone loss during revision total knee arthroplasty (TKA) can be challenging. The degree and location of bone loss often dictates the type of prosthesis that can be utilized during revision surgery. The aim of this prospective study was to determine if plain radiographs are adequate in assessing the degree of bone loss around TKA and identify the limitations of plain radiographs for this purpose, if any.

Methods: 205 patients undergoing revision TKA at our institution were included. The indication for revision was aseptic failure in 120 patients and septic failure in the remaining patients. The plain radiographs were evaluated by a research fellow and the attending surgeon. The degree and the location of bone loss around the TKA was determined using the UPenn Bone Loss chart. The degree of real bone loss was then determined intraoperatively.

Results: The predicted amount of bone loss for the tibia based on the AP (p=0.136) and lateral (p=0.702) radiographs correlated well with the intraoperative findings. However, plain radio-graphs underestimated the degree of bone loss around femur, particularly the condyles (p=0.005).

Discussion: Reconstructive surgeons performing revision TKA need to be aware of the limitations of routine radiographs in assessing the degree of bone loss around the femoral component. Hence, patients undergoing revision TKA with suspected bone loss may need to be evaluated by additional imaging techniques and/or alternative reconstructive options need to be available to deal with greater than expected degree of bone loss intraoperatively.