Dujardin F H, Benez C, Polle G, Alain J, Biga N, Thomine J M
Department of Orthopaedic Surgery, University Hospital of Rouen, Rouen, France.
J Orthop Trauma. 2001 Aug;15(6):401-6. doi: 10.1097/00005131-200108000-00004.
This study aimed at comparing the results obtained with a sliding screw plate and an experimental device including a small-diameter nail that can be placed with a mini-invasive approach and provides a stable fixation.
Randomized prospective study.
University hospital.
The study included two groups with thirty fractures of the trochanteric area.
In both groups, the surgical procedure was carried out on patients placed on a traction table in a supine position, under an x-ray amplifier. Sliding screw plates (THS) were set in place according to the usual open technique. Nails were placed through a twenty-millimeter supratrochanteric cutaneous incision. This experimental system comprised a locked intramedullary nail with two nonparallel seven-millimeter cervicocephalic screws.
The comparison between the two groups was based on the surgical procedure (time, duration of x-ray irradiation, and total blood loss); the initial postoperative period (complications, duration of hospital stay, and the time before returning home); the time before full weight bearing became effective; the functional and social recovery; mortality; and the quality of immediate and final anatomic restitution and healing.
Operating time (p < 0.001) and blood loss (p < 0.001) were lower in the nail group, and no blood transfusion was required. Postoperative pain (p < 0.01), time necessary to support full weight bearing (p < 0.02), and time before returning home (p < 0.05) were reduced in the nail group. All fractures healed in the same amount of time, with good anatomic results in the nail group, whereas ten impactions beyond ten millimeters occurred in the plate group. No difference was found between the two groups in walking ability and autonomy recovery, but hip function (p < 0.05) was better in the nail group.
This preliminary clinical study has shown the advantages of this mini-invasive technique. It could not evaluate all the possible disadvantages inherent in the method. These points will be evaluated in a multicenter study justified by these preliminary results.
本研究旨在比较滑动螺钉钢板与一种实验装置的使用结果，该实验装置包括一枚小直径钉子，可通过微创方法置入并提供稳定固定。
随机前瞻性研究。
大学医院。
本研究包括两组，每组有30例转子区骨折患者。
两组患者均在仰卧位置于牵引台上，在X线增强器下进行手术。按照常规开放技术置入滑动螺钉钢板（THS）。通过20毫米的转子上皮肤切口置入钉子。该实验系统包括一枚带两枚不平行的7毫米头颈螺钉的锁定髓内钉。
两组之间的比较基于手术过程（时间、X线照射时长和总失血量）；术后初期（并发症、住院时间和回家前时间）；完全负重有效的时间；功能和社会恢复情况；死亡率；以及即刻和最终解剖复位与愈合的质量。
钉组的手术时间（p<0.001）和失血量（p<0.001）较低，且无需输血。钉组的术后疼痛（p<0.01）、完全负重所需时间（p<0.02）和回家前时间（p<0.05）均减少。所有骨折在相同时间内愈合，钉组解剖结果良好，而钢板组出现10例超过10毫米的嵌插。两组在行走能力和自主恢复方面无差异，但钉组的髋关节功能更好（p<0.05）。
这项初步临床研究显示了这种微创技术的优势。它无法评估该方法固有的所有可能缺点。这些要点将在由这些初步结果证明合理的多中心研究中进行评估。
