Moed B R, Subramanian S, van Holsbeeck M, Watson J T, Cramer K E, Karges D E, Craig J G, Bouffard J A
Department of Orthopaedic Surgery (K-12), Henry Ford Hospital, Detroit, MI 48202, USA.
J Orthop Trauma. 1998 Mar-Apr;12(3):206-13. doi: 10.1097/00005131-199803000-00013.
Based on the results of a pilot study indicating the potential value of ultrasound (US) as a diagnostic tool for the early assessment of fracture healing and the related need for secondary operative procedures in patients treated by statically locked intramedullary (IM) nailing without reaming, a protocol was established for a larger scale prospective trial. The purpose of this study was to evaluate the outcome of this follow-up trial.
DESIGN/METHODS: All skeletally mature patients admitted to the Henry Ford Hospital (Detroit, Michigan) from January 1993 to August 1994 who had sustained an acute fracture of the tibial shaft and who were treated by statically locked IM nailing, without reaming, were candidates for study. Forty-seven patients with fifty fractures that could be evaluated by US were included. The adopted determinants for fracture healing were complete disappearance of the IM nail on US examination performed at six weeks postoperatively, or progressive disappearance of the nail noted between the initial six-week study and a second nine-week US examination, both in conjunction with periosteal callus formation. Radiographs were obtained to monitor maintenance of reduction and to further evaluate fracture healing.
Of thirty-eight fractures with a positive US (thirty-two at six weeks, six at nine weeks), thirty-seven healed uneventfully, a positive predictive value of 97 percent. Radiographic fracture healing was not evident until, on average, nineteen weeks after injury. The single false-positive fracture progressed to nonunion. Of the twelve fractures with negative US studies, ten underwent secondary procedures (nine dynamization, one bone graft), with four progressing to nonunion. Two patients refused secondary surgery; screw failure occurred in both. Otherwise, there were no hardware failures in this series.
The results of this study indicate that US may provide important prognostic information concerning fracture healing after unreamed tibial nailing, upon which subsequent treatment can be based.
一项初步研究结果表明，超声（US）作为一种诊断工具，对于接受非扩髓静力交锁髓内钉固定治疗的患者早期评估骨折愈合情况及相关二次手术需求具有潜在价值。基于此，制定了一项更大规模前瞻性试验的方案。本研究旨在评估该随访试验的结果。
设计/方法：1993年1月至1994年8月期间入住亨利·福特医院（密歇根州底特律）的所有骨骼成熟患者，若其胫骨干发生急性骨折且接受非扩髓静力交锁髓内钉固定治疗，则纳入研究。47例患者共50处骨折可通过超声进行评估。采用的骨折愈合判定标准为：术后6周超声检查显示髓内钉完全消失，或在最初6周研究与第二次9周超声检查之间观察到髓内钉逐渐消失，且伴有骨膜骨痂形成。拍摄X线片以监测骨折复位情况并进一步评估骨折愈合。
38处超声检查阳性的骨折（6周时32处，9周时6处）中,37处顺利愈合，阳性预测值为97%。平均伤后19周X线片上骨折愈合才明显可见。唯一的假阳性骨折进展为骨不连。12处超声检查阴性的骨折中，10处接受了二次手术（9处动力化，1处植骨），4处进展为骨不连。2例患者拒绝二次手术，二者均发生螺钉失效。除此之外，本系列中未出现内固定失败情况。
本研究结果表明，超声可为非扩髓胫骨髓内钉固定术后骨折愈合提供重要的预后信息，后续治疗可基于此进行。
