Sharrard W J
Royal Hallamshire Hospital, Sheffield, England.
J Bone Joint Surg Br. 1990 May;72(3):347-55. doi: 10.1302/0301-620X.72B3.2187877.
A total of 45 tibial shaft fractures, all conservatively treated and with union delayed for more than 16 but less than 32 weeks were entered in a double-blind multi-centre trial. The fractures were selected for their liability to delayed union by the presence of moderate or severe displacement, angulation or comminution or a compound lesion with moderate or severe injury to skin and soft tissues. Treatment was by plaster immobilisation in all, with active electromagnetic stimulation units in 20 patients and dummy control units in 25 patients for 12 weeks. Radiographs were assessed blindly and independently by a radiologist and an orthopaedic surgeon. Statistical analysis showed the treatment groups to be comparable except in their age distribution, but age was not found to affect the outcome and the effect of treatment was consistent for each age group. The radiologist's assessment of the active group showed radiological union in five fractures, progress to union in five but no progress to union in 10. In the control group there was union in one fracture and progress towards union in one but no progress in 23. Using Fisher's exact test, the results were very significantly in favour of the active group (p = 0.002). The orthopaedic surgeon's assessment showed union in nine fractures and absence of union in 11 fractures in the active group. There was union in three fractures and absence of union in 22 fractures in the control group. These results were also significantly in favour of the active group (p = 0.02). It was concluded that pulsed electromagnetic fields significantly influence healing in tibial fractures with delayed union.
共有45例胫骨干骨折患者进入一项双盲多中心试验，所有患者均接受保守治疗，骨折愈合延迟超过16周但少于32周。这些骨折因存在中度或重度移位、成角或粉碎，或伴有皮肤和软组织中度或重度损伤的复合损伤而被选为易于延迟愈合的病例。所有患者均采用石膏固定治疗，其中20例患者使用有源电磁刺激装置，25例患者使用模拟对照装置，持续12周。由一名放射科医生和一名骨科医生对X光片进行独立盲法评估。统计分析表明，除年龄分布外，治疗组具有可比性，但未发现年龄会影响治疗结果，且每个年龄组的治疗效果一致。放射科医生对治疗组的评估显示，5例骨折实现了放射学愈合，5例骨折有愈合进展，但10例骨折没有愈合进展。在对照组中，1例骨折愈合，1例骨折有愈合进展，但23例骨折没有愈合进展。使用Fisher精确检验，结果非常显著地支持治疗组（p = 0.002）。骨科医生的评估显示，治疗组9例骨折愈合，11例骨折未愈合。对照组3例骨折愈合，22例骨折未愈合。这些结果也显著支持治疗组（p = 0.02）。得出的结论是，脉冲电磁场对延迟愈合的胫骨干骨折的愈合有显著影响。
