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.

Press-fit acetabular reconstructions have become the standard THA; however, controversies remain. The purpose of this study was to critically evaluate serial radiographs for initial cup stability, i.e. gaps and signs of periacetabular interface changes for a porous tantalum monoblock socket.

A multicenter study evaluating 574 primary THRs (542 patients) performed by 9 surgeons at 7 hospitals, all with a monoblock cup without screws. Analyses included clinical outcomes and detailed 2-year minimum radiographic evaluation by one independent observer (mean follow-up, 33 months).

Complications included 9 intra-operative acetabular fractures. Among the 123 cases excluded from radiographic evaluations: deceased (19), lost-to-follow-up (8), 7 early revisions (recurrent dislocations (6) and one trauma-related loosening), and sepsis (3). Patient demographics (414 hips): mean age 65 years (19–93); 58 percent females. Baseline radiographs revealed 113 zones in 85 hips (21 percent) with acetabular gaps; 36 in zone I, 72 in zone II, and 5 in zone III. Of these radiolucencies, 57 zones were 1 mm or less and 56 zones ranged from 2 to 5 mm. At last follow-up, 64 hips (75 percent) had complete gap fill-in, including 100 percent of gaps greater than 3 mm.

There were no socket migrations, no evidence of lysis, no revisions for loosening, and no complete periacetabular interface radiolucencies. The fill-in of preexisting OA cysts and gaps is attributed to adequate initial stability and osteointegration into the porous tantalum. These results suggest that a monoblock cup without screws is an attractive option in THA.