Herberts P, Ahnfelt L, Malchau H, Strömberg C, Andersson G B
Department of Orthopaedics, Sahlgren Hospital, Gothenburg University, Sweden.
Clin Orthop Relat Res. 1989 Dec(249):48-55.
Multicenter clinical trials (MCT) have an important role in the assessment of total joint arthroplasty. The primary reason for such MCT is the need to have access to a large number of patients. In Sweden, failure after total hip arthroplasty has been recorded prospectively since 1979. Medical records from every reoperation are documented and computer analyzed. This MCT has shown that patient-related, surgical, and implant-related parameters are of importance to rates of failure. There were an increasing number of revisions after total hip arthroplasty in Sweden between 1979 and 1986. Male gender and young age increase the risk of revision. The primary diagnosis is very important for type of failure. The risk of deep infection is small but increases with the number of previous operations. Aseptic loosening has emerged as the main problem and is the cause for 74% of all revisions. Prosthetic design is of utmost importance for the rate of failure, and significant differences exist among different prosthesis types with respect to long-term survival. Finally, this MCT has shown that revisions for total hip arthroplasty in patients younger than 70 years of age eventually have failed in Sweden whenever the cemented technique has been used.
多中心临床试验(MCT)在全关节置换术的评估中具有重要作用。进行此类多中心临床试验的主要原因是需要接触大量患者。自1979年以来,瑞典对全髋关节置换术后的失败情况进行了前瞻性记录。每次再次手术的医疗记录都有存档并进行计算机分析。这项多中心临床试验表明,与患者相关、手术相关和植入物相关的参数对失败率很重要。1979年至1986年间,瑞典全髋关节置换术后的翻修手术数量不断增加。男性和年轻患者翻修风险增加。主要诊断对失败类型非常重要。深部感染风险较小,但会随着既往手术次数的增加而升高。无菌性松动已成为主要问题,占所有翻修手术的74%。假体设计对失败率至关重要,不同假体类型在长期生存率方面存在显著差异。最后,这项多中心临床试验表明,在瑞典,只要采用骨水泥技术,70岁以下患者的全髋关节置换术翻修最终都会失败。