Abstract：
UNASSIGNED: Multilayered osteochondral scaffolds are becoming increasingly utilized for the repair of knee joint surface lesions (KJSLs). However, the literature on predictive factors is rather limited.
UNASSIGNED: To (1) evaluate the clinical outcomes and safety of a combined single-step approach using a biomimetic collagen-hydroxyapatite scaffold (CHAS) and filtered bone marrow aspirate (fBMA) for the treatment of KJSLs and (2) identify significant predictors of the treatment outcomes.
UNASSIGNED: Case series; Level of evidence, 4.
UNASSIGNED: All patients who underwent surgery because of a KJSL (size ≥1.5 cm2; International Cartilage Regeneration & Joint Preservation Society grades 3-4) using the combination above were selected from a hospital registry database (100 patients; minimum 2-year follow-up). Patient characteristics, medical history, knee joint and lesion status, intraoperative details, and cellular parameters of the injected fBMA were collected. The arthroscopic evaluation of chondral and meniscal tissue quality in all knee compartments was performed using the Chondropenia Severity Score. Treatment outcomes were determined clinically using patient-reported outcome measures (Knee Injury and Osteoarthritis Outcome Score, EuroQol-5 Dimensions-3 Levels, EuroQol-Visual Analog Scale, and Tegner Activity Scale) and by assessing the occurrence of serious adverse events and graft failure. Multivariable regression analysis was performed to identify significant predictors of the treatment outcomes.
UNASSIGNED: At a mean follow-up of 54.2 ± 19.4 months, 78 (87%) patients completed the questionnaires with significant improvements toward the baseline (P < .00625): KOOS Pain subscale from 62 ± 17 to 79 ± 18, KOOS Total score from 57 ± 16 to 70 ± 20, EuroQol-Visual Analog Scale from 61 ± 21 to 76 ± 16, EuroQol-5 Dimensions-3 Levels from 0.57 ± 0.20 to 0.80 ± 0.21, and Tegner Activity Scale from 2.8 ± 1.5 to 3.9 ± 1.9. The graft failure rate was 4%. A longer duration of preoperative symptoms, previous surgery, larger lesions, older age, and female sex were the main negative predictors for the treatment outcomes. The Chondropenia Severity Score and the number of fibroblast colony-forming units in fBMA positively influenced some of the clinical results and safety.
UNASSIGNED: A CHAS augmented with fBMA proved to be an adequate and safe approach for the treatment of KJSLs up to midterm follow-up. Based on the subanalysis of predictive factors, the surgical intervention should be performed in a timely and precise manner to prevent lesion enlargement, deterioration of the general knee cartilage status, and recurrent surgical procedures, especially in older and female patients. When a CHAS is used, the quantity of MSCs seems to play a role in augmentation.
UNASSIGNED: NCT06078072 (ClinicalTrials.gov identifier).
UNASSIGNED: To (1) evaluate the clinical outcomes and safety of a combined single-step approach using a biomimetic collagen-hydroxyapatite scaffold (CHAS) and filtered bone marrow aspirate (fBMA) for the treatment of KJSLs and (2) identify significant predictors of the treatment outcomes.
UNASSIGNED: Case series; Level of evidence, 4.
UNASSIGNED: All patients who underwent surgery because of a KJSL (size ≥1.5 cm2; International Cartilage Regeneration & Joint Preservation Society grades 3-4) using the combination above were selected from a hospital registry database (100 patients; minimum 2-year follow-up). Patient characteristics, medical history, knee joint and lesion status, intraoperative details, and cellular parameters of the injected fBMA were collected. The arthroscopic evaluation of chondral and meniscal tissue quality in all knee compartments was performed using the Chondropenia Severity Score. Treatment outcomes were determined clinically using patient-reported outcome measures (Knee Injury and Osteoarthritis Outcome Score, EuroQol-5 Dimensions-3 Levels, EuroQol-Visual Analog Scale, and Tegner Activity Scale) and by assessing the occurrence of serious adverse events and graft failure. Multivariable regression analysis was performed to identify significant predictors of the treatment outcomes.
UNASSIGNED: At a mean follow-up of 54.2 ± 19.4 months, 78 (87%) patients completed the questionnaires with significant improvements toward the baseline (P < .00625): KOOS Pain subscale from 62 ± 17 to 79 ± 18, KOOS Total score from 57 ± 16 to 70 ± 20, EuroQol-Visual Analog Scale from 61 ± 21 to 76 ± 16, EuroQol-5 Dimensions-3 Levels from 0.57 ± 0.20 to 0.80 ± 0.21, and Tegner Activity Scale from 2.8 ± 1.5 to 3.9 ± 1.9. The graft failure rate was 4%. A longer duration of preoperative symptoms, previous surgery, larger lesions, older age, and female sex were the main negative predictors for the treatment outcomes. The Chondropenia Severity Score and the number of fibroblast colony-forming units in fBMA positively influenced some of the clinical results and safety.
UNASSIGNED: A CHAS augmented with fBMA proved to be an adequate and safe approach for the treatment of KJSLs up to midterm follow-up. Based on the subanalysis of predictive factors, the surgical intervention should be performed in a timely and precise manner to prevent lesion enlargement, deterioration of the general knee cartilage status, and recurrent surgical procedures, especially in older and female patients. When a CHAS is used, the quantity of MSCs seems to play a role in augmentation.
UNASSIGNED: NCT06078072 (ClinicalTrials.gov identifier).
摘要：
■多层骨软骨支架越来越多地用于修复膝关节表面病变（KJSL）。然而,关于预测因素的文献相当有限。
■目的：（1）使用仿生胶原-羟基磷灰石支架（CHAS）和过滤骨髓穿刺液（fBMA）评估联合一步方法治疗KJSL的临床结果和安全性；（2）确定治疗结果的重要预测因素。
■案例系列；证据级别，4.
■所有因KJSL（大小≥1.5cm2；国际软骨再生和关节保存协会3-4级）使用上述组合而接受手术的患者均从医院注册数据库中选择（100名患者；至少2年随访）。患者特征,病史,膝关节和病变状态，术中细节,收集注射的fBMA的细胞参数。使用软骨减少严重程度评分对所有膝关节隔室的软骨和半月板组织质量进行关节镜评估。使用患者报告的结果指标（膝关节损伤和骨关节炎结果评分，EuroQol-5尺寸-3级，EuroQol-视觉模拟量表，和Tegner活动量表），并通过评估严重不良事件和移植物失败的发生。进行多变量回归分析以确定治疗结果的重要预测因素。
■平均随访54.2±19.4个月，78例（87％）患者完成了问卷调查，相对于基线有了显着改善（P<.00625）：KOOS疼痛子量表从62±17到79±18，KOOS总分从57±16到70±20，EuroQol-视觉模拟量表从61±21到76±16，EuroQol-5维度-3水平从0.57±0.20到0.80，Tegner活动量表从1.9±1.5移植物失败率为4%。术前症状持续时间较长，以前的手术，较大的病变,年龄较大,女性是治疗结局的主要阴性预测因子。软骨减少严重程度评分和fBMA中成纤维细胞集落形成单位的数量对一些临床结果和安全性有积极影响。
■用fBMA增强的CHAS被证明是治疗KJSL直至中期随访的适当且安全的方法。基于对预测因素的亚分析，应及时准确地进行手术干预，以防止病变扩大，一般膝关节软骨状态的恶化，和复发性外科手术，尤其是老年和女性患者。当使用CHAS时，间充质干细胞的数量似乎在增加中起作用。
■NCT06078072（ClinicalTrials.gov标识符）。
■目的：（1）使用仿生胶原-羟基磷灰石支架（CHAS）和过滤骨髓穿刺液（fBMA）评估联合一步方法治疗KJSL的临床结果和安全性；（2）确定治疗结果的重要预测因素。
■案例系列；证据级别，4.
■所有因KJSL（大小≥1.5cm2；国际软骨再生和关节保存协会3-4级）使用上述组合而接受手术的患者均从医院注册数据库中选择（100名患者；至少2年随访）。患者特征,病史,膝关节和病变状态，术中细节,收集注射的fBMA的细胞参数。使用软骨减少严重程度评分对所有膝关节隔室的软骨和半月板组织质量进行关节镜评估。使用患者报告的结果指标（膝关节损伤和骨关节炎结果评分，EuroQol-5尺寸-3级，EuroQol-视觉模拟量表，和Tegner活动量表），并通过评估严重不良事件和移植物失败的发生。进行多变量回归分析以确定治疗结果的重要预测因素。
■平均随访54.2±19.4个月，78例（87％）患者完成了问卷调查，相对于基线有了显着改善（P<.00625）：KOOS疼痛子量表从62±17到79±18，KOOS总分从57±16到70±20，EuroQol-视觉模拟量表从61±21到76±16，EuroQol-5维度-3水平从0.57±0.20到0.80，Tegner活动量表从1.9±1.5移植物失败率为4%。术前症状持续时间较长，以前的手术，较大的病变,年龄较大,女性是治疗结局的主要阴性预测因子。软骨减少严重程度评分和fBMA中成纤维细胞集落形成单位的数量对一些临床结果和安全性有积极影响。
■用fBMA增强的CHAS被证明是治疗KJSL直至中期随访的适当且安全的方法。基于对预测因素的亚分析，应及时准确地进行手术干预，以防止病变扩大，一般膝关节软骨状态的恶化，和复发性外科手术，尤其是老年和女性患者。当使用CHAS时，间充质干细胞的数量似乎在增加中起作用。
■NCT06078072（ClinicalTrials.gov标识符）。
