METHODS: A literature search reporting clinical outcomes after IMN or ORIF of the distal fibula was conducted on PubMed. Inclusion criteria consisted of original studies; studies focusing on clinical outcomes after IMN or IMN and ORIF published before May 11, 2022; studies with at least 5 patients; and studies reporting union rates, complication rates, and patient-reported outcomes such as American Orthopaedic Foot and Ankle Society (AOFAS) and Olerud-Molander scores.
RESULTS: Of 2,394 studies identified, a total of 29 studies (4 LOE-I, 2 LOE-II, 6 LOE-III, 17 LOE-IV) were included consisting of 1,850 IMN patients and 514 plate patients. The pooled mean age of IMN patients was 58 years (95% confidence interval [CI], 54 to 62, I2 = 42%) versus 57 years (95% CI, 53 to 62, I2 = 49%) in ORIF. Union rates for IMN patients revealed a 99% union rate (95% CI, 0.98 to 1.00, I2 = 20%) versus 97% union rate for ORIF patients (95% CI, 0.94 to 0.99, I2 = 0%). Studies that compared IMN with ORIF revealed no difference in union rates (risk ratio [RR] = 0.99, 95% CI, 0.96 to 1.02, I2 = 0%). IMN patients showed a 15% complication rate (95% CI, 0.09 to 0.23, I2 = 89%), whereas plate patients had a complication rate of 30% (95% CI, 0.18 to 0.46, I2 = 63%). When comparing studies with both treatments, IMN patients had a significantly lower risk of complications (RR = 0.49, 95% CI, 0.29 to 0.82, I2 = 50%). The IMN group trended toward a higher mean AOFAS and Olerud-Molander score than the plate group by 4.53 (95% CI, -14.58 to 23.65, I2 = 85%) and 3.54 (95% CI, -2.32 to 9.41, I2 = 76%) points, respectively.
CONCLUSIONS: Current literature reveals near equivalence in union rates and a markedly lower risk of complications when comparing IMN with plate fixation. While IMN patients had higher AOFAS and Olerud-Molander scores, these differences were not statistically significant. Notably, subgroup analyses indicated that rates of symptomatic implant and removal of implant were comparable between IMN and ORIF, which may indicate that wound-related complications were reduced in the minimally invasive IMN technique. While the high cost of IMN implants remains a barrier to their widespread adoption, the long-term benefits of reducing complications, specifically associated with wound complications in high-risk populations, may greatly improve quality of care for patients with distal fibula fractures. Additional research and cost-effectiveness analyses are warranted to fully assess the long-term benefits and economic feasibility of using IMN fixation for distal fibula fractures.
METHODS: Therapeutic Level IV.
方法:在PubMed上进行文献检索,报告腓骨远端IMN或ORIF后的临床结果。纳入标准包括原始研究;关注2022年5月11日前发表的IMN或IMN和ORIF后临床结果的研究;至少有5名患者的研究;以及报告结合率的研究。并发症发生率,和患者报告的结局,如美国骨科足踝协会(AOFAS)和Olerud-Molander评分。
结果:在确定的2,394项研究中,共29项研究(4项LOE-I,2LOE-II,6LOE-III,17LOE-IV)包括1,850名IMN患者和514名钢板患者。IMN患者的合并平均年龄为58岁(95%置信区间[CI],ORIF为54至62,I2=42%)与57年(95%CI,53至62,I2=49%)。IMN患者的结合率显示99%的结合率(95%CI,0.98至1.00,I2=20%)与ORIF患者的97%的结合率(95%CI,0.94至0.99,I2=0%)。将IMN与ORIF进行比较的研究显示,愈合率没有差异(风险比[RR]=0.99,95%CI,0.96至1.02,I2=0%)。IMN患者并发症发生率为15%(95%CI,0.09~0.23,I2=89%),而钢板患者的并发症发生率为30%(95%CI,0.18~0.46,I2=63%).当比较两种治疗方法的研究时,IMN患者的并发症风险显著降低(RR=0.49,95%CI,0.29~0.82,I2=50%)。IMN组的平均AOFAS和Olerud-Molander评分比平板组高4.53(95%CI,-14.58至23.65,I2=85%)和3.54(95%CI,-2.32至9.41,I2=76%)点,分别。
结论:目前的文献显示,IMN与钢板内固定术相比,愈合率接近相等,并发症风险明显降低。虽然IMN患者的AOFAS和Olerud-Molander评分较高,这些差异没有统计学意义.值得注意的是,亚组分析表明,IMN和ORIF之间的有症状的植入物和植入物的移除率相当,这可能表明微创IMN技术减少了伤口相关并发症。虽然IMN植入物的高成本仍然是其广泛采用的障碍,减少并发症的长期好处,特别与高危人群的伤口并发症有关,可以大大提高腓骨远端骨折患者的护理质量。需要进行额外的研究和成本效益分析,以充分评估使用IMN固定治疗腓骨远端骨折的长期效益和经济可行性。
方法:治疗级别IV。