Bhandari Mohit, Guyatt Gordon, Tornetta Paul, Schemitsch Emil H, Swiontkowski Marc, Sanders David, Walter Stephen D
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.
J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694.
There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.
We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.
One thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).
The present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.
扩髓和非扩髓髓内钉治疗胫骨干骨折均有令人信服的生物学理论依据。以往的小型试验使两种方法的证据都尚无定论。我们比较了扩髓和非扩髓髓内钉治疗胫骨干骨折患者的再次手术率和并发症发生率。
我们对1319名接受扩髓或非扩髓髓内钉治疗胫骨干骨折的成年人进行了一项多中心、盲法随机试验。围手术期护理标准化，不允许在六个月前因骨不连进行再次手术。术后十二个月测量的主要复合结局包括骨折间隙<1 cm患者的植骨、植入物更换和动力化。感染和筋膜切开术被视为复合结局的一部分，与术后间隙无关。
1226名参与者（93%）完成了一年的随访。其中，622例患者被随机分配至扩髓髓内钉组，604例患者被随机分配至非扩髓髓内钉组。在所有患者中，57例（4.6%）因骨不连需要更换植入物或植骨。在所有患者中，扩髓髓内钉组105例和非扩髓髓内钉组114例发生主要结局事件（相对风险，0.90；95%置信区间，0.71至1.15）。闭合性骨折患者中，扩髓髓内钉组416例中的45例（11%）和非扩髓髓内钉组410例中的68例（17%）发生主要事件（相对风险，0.67；95%置信区间，0.47至0.96；p = 0.03）。这种差异主要是由于动力化的差异。开放性骨折患者中，扩髓髓内钉组206例中的60例和非扩髓髓内钉组194例中的46例发生主要事件（相对风险，1.27；95%置信区间，0.91至1.78；p = 0.16）。
本研究表明扩髓髓内钉治疗闭合性骨折患者可能有益。我们发现开放性骨折患者两种方法之间无差异。将骨不连的再次手术推迟至少六个月可能会大幅减少再次手术的需求。
