Meta-Regression Result Summary.

BackgroundAvascular necrosis (AVN) of the hip is a disease characterized by vascular disruptions, where 67% of untreated cases may lead to the collapse of the femoral head. None of the current approaches, such as core decompression (CD), vascularized bone grafting, osteotomy, tissue implantation, and other methods, have been proven fully effective in delaying the progression of osteonecrosis. Recent findings indicate that bone marrow stem cells (BMSCs) have significant potential to regenerate necrotic tissue and prevent the progression of AVN in the hip. This study aims to evaluate the efficacy, side effects, treatment failure rate, most effective treatment stage of AVN hip, and application technique to treat AVN hip.MethodWe performed this systematic review and meta-analysis from randomized controlled trials (RCTs) and sources published between 2013 and 2023 from six databases. The literature searching method was based on predetermined PICOS, study eligibility criteria, and PRISMA guidelines. The extracted data were then assessed quantitatively using R Studio with Harris hip score (HHS), Visual analog scale (VAS), the collapse of the femoral head, and conversion of total hip arthroplasty (THA) as the outcomes of interest, then qualitatively using RoB Tool, the extracted data were analyzed using R Studio.ResultA total of 12,939 records were identified through database searching. After the removal of duplicates and non-randomized studies using automation tools, 4,846 articles were screened. Following title and abstract review, 10 studies met the eligibility criteria and were included in the systematic review and meta-analysis, comprising 593 patients and 779 hips.The included studies originated from China (n = 4), France (n = 1), South Korea (n = 1), Australia (n = 1), Iran (n = 1), India (n = 1), and Spain (n = 1). Risk of bias assessment using RoB 2.0 tool revealed 70% of the RCTs were rated as having a low risk of bias, while 30% were judged to have some concerns.Meta-analysis demonstrated that BMSC therapy significantly reduced the risk of femoral head collapse (OR = 0.15; 95% CI: 0.09–0.25; P Meta-regression analyses explored the influence of study-level covariates on outcomes. No predictor reached statistical significance for HHS or THA conversion. However, mean age showed a borderline significant association with VAS (coefficient = −0.8029; P = 0.065), suggesting a possible trend of more significant pain reduction in older patients.ConclusionCurrently established AVN hip treatments are proven to be less effective. The findings strongly support that giving a BMSC at the early-stage AVN hip could improve the patient’s clinical outcome and have fewer side effects and treatment failure compared to conventional treatment.背景 股骨头缺血性坏死（Avascular Necrosis, AVN）是一种以血管破坏为特征的疾病，未接受治疗的病例中有67%可能会出现股骨头塌陷。目前现有治疗手段，如髓芯减压术（Core Decompression, CD）、带血管蒂骨移植术、截骨术、组织植入术等，均未被证实可完全有效延缓骨坏死的进展。近期研究表明，骨髓间充质干细胞（Bone Marrow Stem Cells, BMSCs）在坏死组织再生及延缓髋关节AVN进展方面具有巨大潜力。本研究旨在评估髋关节AVN的BMSC治疗的有效性、不良反应、治疗失败率、最佳治疗阶段以及临床应用技术。 方法 本研究针对2013年至2023年间发表于6个数据库的随机对照试验（Randomized Controlled Trials, RCTs）及相关文献开展系统评价与荟萃分析。文献检索基于预先设定的PICOS原则、研究纳入标准及PRISMA指南进行。提取的数据首先以R Studio进行定量分析，研究结局指标包括髋关节Harris评分（Harris Hip Score, HHS）、视觉模拟评分法（Visual Analog Scale, VAS）、股骨头塌陷情况及全髋关节置换术（Total Hip Arthroplasty, THA）转换率；随后采用偏倚风险（Risk of Bias, RoB）工具进行定性分析，所有数据均通过R Studio完成分析。 结果 数据库检索共检出12939条记录。通过自动化工具剔除重复文献与非随机对照研究后，筛选得到4846篇文章。经标题与摘要审核后，最终纳入10项符合标准的研究，涉及593名患者及779个髋关节。纳入研究分别来自中国（n=4）、法国（n=1）、韩国（n=1）、澳大利亚（n=1）、伊朗（n=1）、印度（n=1）及西班牙（n=1）。采用RoB 2.0工具进行偏倚风险评估结果显示，70%的RCTs被评为低偏倚风险，剩余30%存在一定偏倚风险担忧。荟萃分析结果显示，BMSC治疗可显著降低股骨头塌陷风险（OR=0.15；95%CI：0.09~0.25；P）。亚组回归分析探索了研究水平协变量对结局的影响，未发现任何协变量对HHS或THA转换率存在统计学显著性关联。不过，患者平均年龄与VAS评分存在临界显著性关联（系数=-0.8029；P=0.065），提示老年患者的疼痛缓解程度可能更为显著。 结论 目前已有的髋关节AVN治疗手段疗效欠佳。本研究结果强烈支持，相较于传统治疗，在髋关节AVN早期阶段实施BMSC治疗可改善患者临床结局，且不良反应与治疗失败率更低。