Free Vascularized Fibular Grafting Improves Vascularity Compared With Core Decompression in Femoral Head Osteonecrosis: A Randomized Clinical Trial
Free Vascularized Fibular Grafting Improves Vascularity Compared With Core Decompression in Femoral Head Osteonecrosis: A Randomized Clinical Trial
复制标题
与股骨头坏死中的核心减压相比，游离血管化腓骨移植可改善血管分布：一项随机临床试验
DOI：
10.1007/s11999-017-5374-x
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发表时间：
2017-09-01
影响因子：
4.2
通讯作者：
Yan, Zuoqin
中科院分区：
文献类型：
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作者：
Cao, Lu;Guo, Changan;Yan, Zuoqin
背景股骨头坏死的治疗仍然具有挑战性。髓芯减压和带血管蒂腓骨移植是治疗股骨头坏死的常用手术方法。然而，很少有研究比较这两个程序在一个随机对照研究，在改善血管的股骨头，疾病的进展，或髋scores.Question/purposes（1）什么是影响核心减压和腓骨移植对血管的股骨头测量单光子发射CT（SPECT）/CT？(2)这两种方法中的一种是否会导致通过系列MRI确定的循环骨协会研究（阿科）分期的更大进展？(3)以Harris髋关节评分（HHS）测量的股骨头血管分布变化与髋关节功能之间的关系以及进展至THA作为终点之间的关系是什么？方法2010年6月至2012年10月在复旦大学附属中山医院进行随机对照试验。在研究期间，51名患有阿科I至IIIB期双侧骨坏死的患者可能有资格入选，33名患者被确定为符合入选标准，并提供了入组和随机化。6名患者在随机化时拒绝参加，最终样本为27名参与者（54例髋关节）。每例患者的双侧髋关节被随机分配到手术选项：一侧进行髓芯减压治疗，对侧同时进行腓骨移植治疗。在治疗前和术后6个月和36个月进行SPECT/CT检查以定量放射性核素摄取，以评估股骨头的血管分布。根据现有数据，我们发现两组基线时的血管分布无差异（64% ± 8%的核心减压治疗髋关节vs 64% ± 7%的腓骨移植髋关节; 95% CI，−5%至5%; p = 0.90）。在术前和术后6、12、24和36个月获得髋关节的MR图像，并根据阿科分类进行分期。所有患者在治疗前进行临床评估，并在治疗后6、12、18、24、30和36个月使用HHS进行随访。我们认为HHS差异10为最小临床重要差异（MCID）。将患者进展至THA定义为随访终点。6例患者（22%）失访。结果通过SPECT/CT分析，6个月时，减压治疗髋关节的血管分布低于腓骨移植髋关节（68% ± 6% vs 95% ± 5%;平均差异，−27%; 95% CI，−32%至−23%; p < 0.001）和36个月（57% ± 4% vs 91% ± 3%;平均差异，−34%; 95% CI，−37%至−32%; p < 0.001）。MRI分析显示，减压治疗髋关节和腓骨移植髋关节在12个月（p = 0.306）和24个月（p = 0.06）时的阿科分期方面无差异。36个月时，减压组的阿科分期进展比腓骨移植组更严重（p = 0.027）。在整个随访期间，减压组的平均HHS低于腓骨移植组，尽管这些差异在早期等于或低于MCID 10分。然而，到18个月时，评分有利于腓骨移植（72 ± 4 vs. 84 ± 4;平均差异，−13; 95%CI，−15至−7; p < 0.001），这一结果在24、30和36个月时保持不变。我们没有发现...
BackgroundManagement of osteonecrosis of the femoral head remains challenging. Core decompression and free vascularized fibular grafting are commonly used surgical procedures for treatment of osteonecrosis of the femoral head. Few studies, however, have compared these two procedures in a randomized controlled study, in terms of improved vascularity of the femoral head, progression of disease, or hip scores.Question/purposes(1) What is the effect of core decompression and fibular grafting on vascularity of the femoral head as measured by single-photon emission CT (SPECT)/CT? (2) Does one of these two methods lead to greater progression of Association Research Circulation Osseous (ARCO) stage as determined by serial MRI? (3) What is the relationship between the change in vascularity of the femoral head and hip function as measured by the Harris hip score (HHS) and progression to THA as an endpoint?MethodsA randomized controlled trial was performed between June 2010 and October 2012 at Zhongshan Hospital, Fudan University. During the study period, 51 patients who presented with ARCO Stages I to IIIB bilateral osteonecrosis were potentially eligible for inclusion, and 33 patients were identified as meeting the inclusion criteria and offered enrollment and randomization. Six patients declined to participate at the time of randomization, leaving a final sample of 27 participants (54 hips). Bilateral hips of each patient were randomly assigned to surgical options: one side was treated with core decompression and the contralateral side was concurrently treated with fibular grafting. SPECT/CT examinations were performed to quantify radionuclide uptake to evaluate vascularity of the femoral head before treatment and at 6 and 36 months after surgery. With the numbers available, we found no differences between the groups regarding vascularity at baseline (64% ± 8% core decompression-treated hips versus 64% ± 7% in the fibular-grafted hips; 95% CI, −5% to 5%; p = 0.90). MR images of the hips were obtained before surgery and at 6, 12, 24, and 36 months postoperatively and staged based on the ARCO classification. All patients were assessed clinically before treatment and followed up at 6, 12, 18, 24, 30, and 36 months after treatment using the HHS. We considered a difference in the HHS of 10 as the minimal clinically important difference (MCID). Patient progression to THA was defined as the endpoint for followup. Six patients (22%) were lost to followup.ResultsBy SPECT/CT analysis, decompression-treated hips had lower vascularity than fibular-grafted hips at 6 months (68 % ± 6% versus 95% ± 5%; mean difference, −27%; 95% CI, −32% to −23%; p < 0.001) and 36 months (57% ± 4% versus 91% ± 3%; mean difference, −34%; 95% CI, −37% to −32%; p < 0.001). MRI analysis showed no differences between decompression-treated hips and fibular-grafted hips regarding ARCO stage at 12 months (p = 0.306) and 24 months (p = 0.06). Progression of ARCO staging was more severe in the decompression group than the fibular grafting group at 36 months (p = 0.027). The mean HHS was lower in the decompression group than in the fibular grafting group throughout the followup period, although these differences were at or below the MCID of 10 points early on. However, by 18 months, the scores favored fibular grafting (72 ± 4 versus 84 ± 4; mean difference, −13; 95% CI, −15 to −7; p < 0.001), a finding that was maintained at 24, 30, and 36 months. We found no differences between …