Clinical Sciences Research Institute, University of Warwick Medical School, Coventry, UK.
BMC Musculoskelet Disord. 2010 Aug 17;11:184. doi: 10.1186/1471-2474-11-184.
Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system.
We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system.
Current Controlled Trials ISRCTN49197425.
对于移位型囊内股骨近端骨折患者，最佳治疗方法存在争议。公认的治疗选择包括关节置换和内固定。内固定的主要批评是不愈合率高；多达 30%的患者会出现固定失败，需要进行翻修手术。我们认为，改善骨折愈合可能会降低固定失败的发生率。因此，我们提出了研究加速骨折愈合和改善固定的策略，这可能会显著改善囊内股骨骨折内固定后的结果。我们旨在测试富含血小板的血浆这种成骨诱导剂的临床效果，并对一种新型的角度固定系统进行试点研究。
我们计划进行一项三臂、单中心、标准护理对照、双盲、实用、随机临床试验。该试验将包括富含血小板的血浆和标准护理固定与标准护理固定单独治疗之间的标准双向比较。此外，还将进行一个辅助的试点臂，测试一种角度固定螺钉和钢板固定系统。
当前对照试验 ISRCTN49197425。
