The purpose of this study was to determine the benefit and risk of NSAID-based prophylaxis for ectopic bone formation amongst patients undergoing total hip replacement (or revision) surgery.

A double-blind randomised placebo-controlled clinical trial, stratified by treatment site and surgery (primary or revision), was conducted in 20 orthopaedic surgery centres in Australia and New Zealand. 902 patients, undergoing elective primary or revision total hip replacement surgery, were randomly allocated to 14 days treatment with ibuprofen (1200mg daily) or matching placebo commenced within 24 hours of surgery. Patients were only excluded if there was, in the opinion of the responsible physician, a definite indication or contra-indication for treatment with an NSAID during the 14 day study treatment period. Outcomes were assessed six to 12 months after surgery and included changes in self-reported hip pain and physical function (WOMAC), physical performance measures and radiographic evidence of ectopic bone formation.

There was only a 6% loss to follow-up for self-report measures and a 12% loss to follow-up for radiographs. Six to twelve months after surgery, there were no significant differences between the ibuprofen and placebo groups for improvements in hip pain (mean difference, 95% confidence interval: −0.1, −0.4 to 0.2, p=0.6) or physical function (−0.1, −0.4 to 0.2, p=0.5), despite a much reduced risk of ectopic bone formation (relative risk 0.69, 95% confidence interval 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications during the admission period (2.09, 1.00 to 4.39)

These data, from the largest-ever trial of prophylaxis against ectopic bone formation, do not support the use of routine NSAIDs-based prophylaxis for patients undergoing total hip replacement surgery.

Introduction: A small, yet not uncommon, problem following total joint arthroplasty (TJA) is post-operative ileus (POI). The purpose of this study was two-fold. First the study sought to determine the incidence of POI after TJA in a consecutive series of patients receiving regional anesthesia and an aggressive postoperative rehabilitation protocol. Second, the influence of narcotic medications, including intrathecal medications, in the incidence of POI was examined.

Methods: 5,262 patients underwent total joint replacements, including primary and revision surgery, at our institution from 2004 to 2005. All surgeries were performed at a university-affiliated institution where complications, if any, are prospectively recorded in a comprehensive database. Demographic, clinical, surgical, and radiographic details were obtained and examined.

Results: 26 (0.5%) patients developed ileus. There were 17 males and 9 female patients, who had a mean age of 67.7 years (range, 52.7 to 91.2 years). The mean BMI was 30.2 kg/m2. The index procedures included 15 primary hip, 4 primary knee, 4 revision hip, and 3 revision knee procedures. Of the patients who developed ileus, intrathecal narcotics were administered in 16 patients (62%).

Discussion: There is a very low incidence of postoperative ileus and gastrointenstinal hypomobility following joint arthroplasty. Early patient ambulation, a reduction in the use of postoperative narcotics, supplementation of analgesia with non-narcotic drugs, and reduced length of hospital stay may all have an important role in reducing this complication. Based on our findings, it seems unlikely that intrathecal narcotics have an adverse effect on gastrointestinal motility.

A recent systematic overview of 213 studies of more than 50,000 patients showed that ectopic bone formation (EBF) is present on the radiographs of about 40% of all patients who have undergone elective hip arthroplasty and in at least half of these, EBF is rated moderate to severe and is associated with an increased risk of an impaired functional outcome. A recent meta-analysis of more than a dozen trials of NSAIDs in patients at risk of EBF has demonstrated that perioperative treatment reduces the risk of EBF by about 50%. However, prophylaxis is rarely given in clinical practice due to concerns about perioperative bleeding, gastrointestinal events and implant loosening, combined with a lack of data on the clinical importance of EBF. The HIPAID study involves the conduct of a randomized double blind clinical trial, designed to assess the effects of a 15 day peri-operative course of ibuprofen (1200mg daily) on the clinical consequences of EBF in individuals undergoing total hip replacement surgery. The trial will be conducted in 20 orthopaedic centers throughout Australia and New Zealand, and will involve 1,000 patients aged 60 to 80 years, scheduled for elective total hip replacement surgery. The primary study outcomes are self-reported pain and physical function, assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), six months after surgery. Secondary outcomes include EBF, health-related quality of life (SF-36v2), patient’s global assessment, hip flexion and the 50ft walk time. Peri- and early postoperative events will be assessed including bleeding and gastro-intestinal complaints.

The Pulmonary Embolism Prevention (PEP) Trial was designed to assess the effects of a 35 day course of aspirin (160 mg daily) on the risks of thromboembolic events, other cardiovascular outcomes and bleeding among individuals undergoing surgery for hip fracture or joint replacement. From 1992 to 1998, 148 hospitals in Australia, New Zealand, South Africa, Sweden and the United Kingdom randomised 13,356 hip fracture patients, and 22 hospitals in New Zealand randomised 4,088 elective arthroplasty patients. Among hip fracture patients, aspirin produced proportional reductions in PE of 43% (95% confidence interval [CI] 18% to 60%; 2P=0.002) and symptomatic DVT of 29% (95% CI 3% to 48%; 2P=0.03). PE or DVT was confirmed in 105 (1.6%) of 6679 patients allocated aspirin versus 165 (2.5%) of 6677 allocated placebo, representing an absolute reduction of 9±2 per 1000 and a proportional reduction of 36% (95% CI 19% to 50%; 2P=0.0003). Aspirin prevented 4±1 fatal pulmonary emboli per 1000 treated (18 aspirin vs 43 placebo deaths), representing a proportional reduction of 58% (95% CI 27% to 76%; 2P=0.002), with no apparent effect on deaths from other vascular (hazard ratio 1.04; 95% CI 0.86 to 1.26) or non-vascular cause (1.01; 95% CI 0.84 to 1.23). Deaths due to bleeding were rare (13 aspirin vs 15 placebo), but there was an excess of 6±3 post-operative transfused bleeds per 1000 allocated aspirin (2P=0.04). Among elective arthroplasty patients, venous thromboembolism rates were lower but the proportional effects of aspirin appeared similar to those among hip fracture patients.