METHODS: A total of 146 adults younger than 55 years old with high-energy Pauwels type III FNFs were randomized to receive CBS fixation or OPTCS fixation. Primary outcomes were complication rates, including fixation failure, fracture nonunion, and avascular necrosis of the femoral head (ANFH) at 24 months after treatment. Fixation loosening, femoral neck shortening and varus collapse, patient function and quality of life using the Harris hip score (HHS), and EuroQol-5 dimensional-5 levels (EQ-5D-5L) questionnaire (including EQ-5D-5L and EQ-VAS) were assessed as secondary outcomes at 24 months.
RESULTS: CBS and OPTCS fixation groups were similar with regard to demographics at baseline. At 24 months, patients in the CBS fixation cohort had a significantly lower rate of fixation failure (10.5% vs. 25.0%, p = 0.041) and fracture nonunion (1.8% vs. 18.3%, p = 0.003) compared with patients who received OPTCS fixation. There was no difference in rate of ANFH (7.0% vs. 11.7%, p = 0.389) between groups. Additionally, patients managed with CBS fixation showed significantly less fixation loosening (19.3% vs. 58.3%, p < 0.001), less severe femoral neck shortening and varus collapse (10.5% vs. 25.0%, p = 0.007), higher HHS (93 vs. 83, p = 0.001) and more excellent grade (68.4% vs. 36.7%, p = 0.008), higher EQ-5D-5L (0.814 vs, 0.581, p < 0.001) and EQ-VAS (85 vs. 80, p = 0.002).
CONCLUSIONS: CBS screw fixation confers significantly lower complication rate in addition to higher functional and quality of life outcomes for young adults with high-energy FNF compared with OPTCS fixation.
BACKGROUND: This prospective, randomized controlled trial was approved by the institutional review board of our center, Ethics Committee of Shanghai sixth people\'s Hospital, and registered at www.chictr.org.cn (Approval Number: ChiCTR1900026283; Registered 29 September 2019-Retrospectively registered, https://www.chictr.org.cn/showproj.html?proj=43164 ).
方法:共有146名55岁以下的高能量PauwelsIII型FNF患者随机接受CBS固定或OPTCS固定。主要结果是并发症发生率,包括固定失败,骨折不愈合,治疗后24个月出现股骨头缺血性坏死(ANFH)。固定松动,股骨颈缩短和内翻塌陷,使用Harris髋关节评分(HHS)的患者功能和生活质量,和EuroQol-5维-5水平(EQ-5D-5L)问卷(包括EQ-5D-5L和EQ-VAS)在24个月时作为次要结局进行评估.
结果:CBS和OPTCS固定组的基线人口统计学相似。24个月时,CBS固定队列患者的固定失败率明显较低(10.5%vs.25.0%,p=0.041)和骨折不愈合(1.8%vs.18.3%,p=0.003)与接受OPTCS固定的患者相比。ANFH的发生率没有差异(7.0%与11.7%,组间p=0.389)。此外,接受CBS固定治疗的患者的固定松动明显减少(19.3%vs.58.3%,p<0.001),不太严重的股骨颈缩短和内翻塌陷(10.5%vs.25.0%,p=0.007),较高的HHS(93vs.83,p=0.001)和更优秀的等级(68.4%与36.7%,p=0.008),更高的EQ-5D-5L(0.814vs,0.581,p<0.001)和EQ-VAS(85vs.80,p=0.002)。
结论:与OPTCS固定相比,对于高能量FNF的年轻成年人,CBS螺钉固定除了具有更高的功能和生活质量外,还可显著降低并发症发生率。
背景:这种前瞻性,随机对照试验得到了我们中心机构审查委员会的批准,上海市第六人民医院伦理委员会,并在www注册。chictr.org.cn(批准号:ChiCTR1900026283;2019年9月29日注册-回顾性注册,https://www.chictr.org.cn/showproj.html?proj=43164)。