Randomised trial of ibuprofen for the prevention of ectopic bone-related pain and disability after hip replacement

布洛芬预防髋关节置换术后异位骨相关疼痛和残疾的随机试验

• 批准号: nhmrc : 153712
• 负责人: Andrew Ellis
• 金额: $ 24.29万
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2001
• 资助国家: 澳大利亚
• 起止时间: 2001-01-01 至 2003-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/randomised-trial-ibuprofen-hip-replacement/80794
• 关键词: Randomised; trial; ibuprofen; prevention; ectopic

Joint replacement is a well-established treatment for severe osteoarthritis of the hip. While most patients benefit substantially from the procedure, many still experience some pain and disability after surgery. New evidence suggests that one important cause of this pain and disability may be abnormal bone deposits that form in the muscles around the hip (ectopic bone formation) during the first few months after surgery. Ectopic bone formation is seen in about 40% of all patients with hip replacements. If the formation is extensive, all movement of the hip is lost and revision surgery is necessary. However, even when the formation is less severe, movement at the hip can be restricted resulting in pain and disability. There is growing evidence that treatment with a non-steroidal anti-inflammatory drug at the time of surgery may halve the risk of ectopic bone formation. While this would be expected to decrease the risk and severity of post-operative pain and disability, there is little evidence available about the long-term effects of these drugs after hip replacement. For this reason, together with concerns about possible side-effect of these drugs, orthopaedic surgeons have generally been reluctant to prescribe these drugs routinely for the prevention of ectopic bone formation. Ibuprofen appears to be the non-steroidal anti-inflammatory drug with the lowest risk of side effects. If it was shown to be effective in reducing the incidence of pain and disability associated with ectopic bone formation after hip replacement, it may well be considered worthwhile by doctors and patients alike. If such benefits were realised, this preventive strategy is likely to be a highly cost-effective way to improve long-term outcome among the rapidly growing numbers of patients that receive hip replacements. This study will provide reliable evidence about the short and long-term effects of ibuprofen among 1,000 patients receiving hip replacements in Australia.

关节置换术是治疗严重髋关节骨性关节炎的有效方法。虽然大多数患者从手术中受益良多，但许多人在手术后仍会经历一些疼痛和残疾。新的证据表明，这种疼痛和残疾的一个重要原因可能是手术后最初几个月在髋部周围肌肉中形成的异常骨沉积(异位骨形成)。在所有髋关节置换术的患者中，约有40%可见异位骨形成。如果形成范围很广，髋关节的所有活动都会丧失，需要进行翻修手术。然而，即使在形成不那么严重的情况下，髋部的运动也可能受到限制，导致疼痛和残疾。越来越多的证据表明，在手术时使用非类固醇抗炎药可能会将异位骨形成的风险减半。虽然这有望降低术后疼痛和残疾的风险和严重程度，但几乎没有证据表明这些药物在髋关节置换后的长期效果。出于这个原因，再加上对这些药物可能产生的副作用的担忧，骨科医生通常不愿常规地开出这些药物来预防异位骨形成。布洛芬似乎是副作用风险最低的非类固醇抗炎药。如果能有效地减少髋关节置换术后异位骨形成相关的疼痛和残疾的发生率，医生和患者都很有可能认为它是值得的。如果实现了这些好处，这种预防性策略很可能是一种极具成本效益的方式，可以改善迅速增长的接受髋关节置换的患者的长期结果。这项研究将为在澳大利亚接受髋关节置换术的1000名患者使用布洛芬的短期和长期效果提供可靠的证据。