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Regenerative Medicine: The Next Generation of Autologous Blood Formulations. 再生医学:下一代自体血液配方。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-10-04 DOI: 10.1177/15563316251367029
Cameron Miller, Asheesh Bedi

In the treatment of osteoarthritis and soft tissue injury, early basic science and clinical data have been promising for the use of autologous blood formulations. This review article explores autologous conditioned serum, alpha-2-macroglobulin, and autologous protein solution, which function via overlapping but distinct mechanisms to reduce inflammation, counteract catabolism, and improve joint homeostasis. The ideal timing and quantity of dosing are largely unknown and may vary based on indication. Additional high-quality clinical trials are necessary to define the efficacy of these interventions on both long-term symptomatic improvement and mitigation of osteoarthritic disease progression.

在骨关节炎和软组织损伤的治疗中,早期的基础科学和临床数据已经显示出使用自体血液制剂的前景。这篇综述文章探讨了自体条件血清、α -2巨球蛋白和自体蛋白溶液,它们通过重叠但不同的机制来减少炎症、对抗分解代谢和改善关节稳态。理想的给药时间和剂量在很大程度上是未知的,并且可能根据适应症而变化。需要更多的高质量临床试验来确定这些干预措施在长期症状改善和缓解骨关节炎疾病进展方面的疗效。
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引用次数: 0
Complication Profiles Leading to Revision Surgery After Cervical Disc Arthroplasty. 颈椎间盘置换术后翻修手术的并发症概况。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-10-02 DOI: 10.1177/15563316251364734
Giuseppe Loggia, Franziska C S Altorfer, Fedan Avrumova, Celeste Abjornson, Jiaqi Zhu, Darren R Lebl

Background: Cervical disc arthroplasty (CDA) has gained widespread recognition as a motion-preserving alternative to anterior cervical discectomy and fusion for treating degenerative cervical disc disease. Over the past decade, the rate of CDA procedures has increased by a remarkable 654%. However, CDA complications can lead to a repeat procedure or can be converted to fusion.

Purpose: We sought to evaluate the time of onset (early, intermediate, or late) of complications following CDA as well as the progression leading to revision surgeries.

Methods: A retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database examined complications across 9 CDA devices from January 1, 2005, to September 30, 2023. Complications were categorized by postoperative time to occurrence: early (<6 months), intermediate (6-18 months), and late (>18 months). The revision procedures were categorized as either a repeat CDA or conversion to fusion.

Results: A total of 688 CDA revision cases were reviewed, with 265 cases (38.5%) reporting revision onset time (median: 12 months, interquartile range: 3-36). Migration was the most frequent complication in both the early (n = 44, 53.0%) and intermediate (n = 25, 32.1%) periods. Subsidence peaked during the intermediate period (11.5%, n = 9), while neck pain and heterotopic ossification (HO) occurred most in the late postoperative phase, at 22.5% (n = 23) and 7.8% (n = 8), respectively. The specific revision type was recorded in 509 of the revision cases; of these, 8 devices were predominantly associated with fusion (>69%), while Mobi-C showed a lower proportion of fusion revisions (16.2%).

Conclusions: This retrospective review of the MAUDE database showed the timing of complications leading to CDA revision. Migration predominated in the early and intermediate phases, while subsidence peaked in the intermediate phase. In the late phase, neck pain, osteolysis, and HO become more prominent. Conversion to fusion was common across most devices. These data provide insight for clinicians to monitor patients after CDA while considering the relative frequencies of reported complications.

Level of evidence: Level IV: retrospective analysis of a prospectively maintained government database.

背景:颈椎间盘置换术(CDA)作为一种保留运动的替代方案已被广泛认可,用于治疗退行性颈椎间盘疾病。在过去的十年中,CDA程序的比率显著增加了654%。然而,CDA并发症可导致重复手术或可转为融合。目的:我们试图评估CDA术后并发症的发病时间(早期、中期或晚期)以及导致翻修手术的进展。方法:对美国食品和药物管理局制造商和用户设施设备体验(MAUDE)数据库进行回顾性审查,检查2005年1月1日至2023年9月30日期间9个CDA设备的并发症。并发症按术后发生时间分类:早期(18个月)。修订程序被分类为重复CDA或转换为融合。结果:共回顾688例CDA翻修病例,265例(38.5%)报告翻修开始时间(中位数:12个月,四分位数范围:3-36)。迁移是早期(n = 44, 53.0%)和中期(n = 25, 32.1%)最常见的并发症。下陷在中期达到高峰(11.5%,n = 9),而颈部疼痛和异位骨化(HO)在术后后期发生最多,分别为22.5% (n = 23)和7.8% (n = 8)。在509个修订案例中记录了具体修订类型;其中,8个设备主要与融合相关(>69%),而Mobi-C显示融合修正的比例较低(16.2%)。结论:对MAUDE数据库的回顾性审查显示了导致CDA修订的并发症的时间。早中期以运移为主,中期以沉降为主。在晚期,颈部疼痛、骨溶解和HO变得更加突出。转换为核聚变在大多数设备中都很常见。这些数据为临床医生在考虑报告并发症的相对频率的同时监测CDA后的患者提供了见解。证据等级:四级:对前瞻性维护的政府数据库进行回顾性分析。
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引用次数: 0
Unique Activity Characteristics of Adolescents With Patellar Dislocations: A Retrospective Review at a Single Institution. 青少年髌骨脱位的独特活动特征:单一机构的回顾性回顾。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-09-27 DOI: 10.1177/15563316251372594
Danielle E Chipman, Yukiko Matsuzaki, Gabrielle Dykhouse, Preston W Gross, Peter M Cirrincione, Ruth H Jones, Peter D Fabricant, Daniel W Green

Background: While much evidence exists on the epidemiology of and prevention strategies for anterior cruciate ligament (ACL) injuries, there is less information on patellar dislocations.

Purpose: We sought to compare the activities of adolescents who underwent a medial patellofemoral ligament reconstruction (MPFLR) to those who underwent an ACL reconstruction (ACLR).

Methods: We conducted a retrospective review of routinely collected preoperative data of adolescent patients who underwent either an MPFLR or ACLR by 1 of 2 fellowship-trained pediatric sports medicine orthopedic surgeons at a single institution between February 1, 2016, and April 15, 2023. A total of 912 patients were identified, and 540 of these met the final inclusion and exclusion criteria. A total of 228 MPFLR participants were successfully matched to 228 ACLR participants based on sex and age within 1 year at the time of surgery. The mean age was 14.8 ± 2.1 years and 53% were female. The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS), Pediatric International Knee Documentation Committee, Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, and PROMIS Mobility were collected.

Results: We found that 61% of the MPFLR cohort and 94% of the ACLR cohort sustained their injuries while playing an organized sport. The MPFLR group had significantly lower HSS Pedi-FABS scores than the ACLR group, suggesting that the MPFLR group had lower preoperative athletic activity levels compared to the ACLR group.

Conclusions: In this retrospective study, participation in organized sports was associated with 61% of patellar dislocations. Among girls, dance was the second most common sport participated in at the time of patellar dislocation. This suggests that further investigation into injury prevention strategies for adolescent female dancers is warranted.

Level of evidence: Level III: Retrospective therapeutic study.

背景:虽然关于前交叉韧带(ACL)损伤的流行病学和预防策略有很多证据,但关于髌骨脱位的信息较少。目的:我们试图比较接受内侧髌股韧带重建(MPFLR)和接受前交叉韧带重建(ACLR)的青少年的活动。方法:我们对2016年2月1日至2023年4月15日在同一家机构接受过2名获得奖学金的儿童运动医学骨科医生中的1名接受MPFLR或ACLR手术的青少年患者的常规术前数据进行了回顾性分析。共确定912例患者,其中540例符合最终纳入和排除标准。在手术时1年内,共有228名MPFLR参与者根据性别和年龄成功匹配了228名ACLR参与者。平均年龄14.8±2.1岁,女性占53%。收集特殊外科医院儿童功能活动简要量表(HSS Pedi-FABS)、儿科国际膝关节文献委员会、患者报告结果测量信息系统(PROMIS)疼痛干扰和PROMIS活动能力。结果:我们发现61%的MPFLR组和94%的ACLR组在参加有组织的运动时受伤。MPFLR组HSS Pedi-FABS评分明显低于ACLR组,表明MPFLR组术前运动水平低于ACLR组。结论:在这项回顾性研究中,参加有组织的运动与61%的髌骨脱位有关。在女孩中,舞蹈是髌骨脱位时第二常见的运动。这表明进一步调查伤害预防策略的青少年女舞者是必要的。证据等级:III级:回顾性治疗性研究。
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引用次数: 0
A New Era of Regenerative Medicine, With Longevity as the Cornerstone. 以长寿为基石的再生医学新时代。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-09-25 DOI: 10.1177/15563316251367018
Steven R Cohen
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引用次数: 0
Regenerative Medicine: Tremendous Potential but Not Quite Ready for Prime-Time. 再生医学:潜力巨大,但尚未完全成熟。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-09-04 DOI: 10.1177/15563316251366180
Scott A Rodeo

This guest editorial gives an overview of the field of regenerative medicine and the special issue.

这篇客座社论概述了再生医学领域和特刊。
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引用次数: 0
Ethical and Regulatory Considerations Related to Regenerative Medicine. 与再生医学相关的伦理和监管考虑。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-08-30 DOI: 10.1177/15563316251361511
Prathap Jayaram, Richard M Danilkowicz, Xiaoning Yuan

The possibility of modifying disease through regenerative medicine applications, particularly stem cell therapies, raises ethical and regulatory challenges in orthopedics. This review article provides historical context of stem cell research, ethical issues such as informed consent, therapeutic misconception, and equitable access, emphasizing the responsibilities of providers offering investigational treatments. It also examines the evolving role of the U.S. Food and Drug Administration (FDA) in regulating regenerative therapies through frameworks like the Regenerative Medicine Advanced Therapy (RMAT) designation, and more point-of-care enforcement discretion policies for therapies such as autologous micro-fragmented adipose tissue and bone marrow aspirate concentrate. The authors underscore the importance of innovative therapies to address unmet needs in musculoskeletal healthcare while acknowledging the need for more rigorous basic and clinical research. They call for a continuous refinement of regulatory and ethical standards as regenerative medicine advances.

通过再生医学应用,特别是干细胞治疗来改变疾病的可能性,在骨科领域提出了伦理和监管方面的挑战。这篇综述文章提供了干细胞研究的历史背景、诸如知情同意、治疗误解和公平获取等伦理问题,强调了提供研究性治疗的提供者的责任。它还研究了美国食品和药物管理局(FDA)在通过再生医学高级疗法(RMAT)指定等框架来调节再生疗法方面的不断发展的作用,以及针对自体微碎片化脂肪组织和骨髓抽吸浓缩液等疗法的更多护理点执行自由裁量权政策。作者强调了创新疗法的重要性,以解决肌肉骨骼保健方面未满足的需求,同时承认需要进行更严格的基础和临床研究。他们呼吁随着再生医学的进步,不断完善监管和伦理标准。
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引用次数: 0
Clinical Applications of Stromal Vascular Fraction and Stromal Vascular Matrix for Osteoarthritis: A Commentary. 间质血管分数和间质血管基质在骨关节炎中的临床应用综述。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-08-28 DOI: 10.1177/15563316251364264
Burak Beksaç
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引用次数: 0
Potential Medical and Surgical Applications of Stromal Vascular Fraction and Adipose-Derived Stem Cells: A Narrative Review. 基质血管部分和脂肪来源干细胞的潜在医学和外科应用:叙述性综述。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-08-28 DOI: 10.1177/15563316251361918
Steven R Cohen, Jordan Wesson, Serli Canikyan, Tunç Tiryaki

Adipose-derived cellular therapies, including stromal vascular fraction (SVF) and adipose-derived stem cells (ASCs), have demonstrated increasing therapeutic potential across regenerative medicine applications. This narrative review examines the current evidence supporting the use of SVF and ASCs in 2 primary clinical contexts: osteoarthritis (OA) and chronic wound healing. SVF, a heterogeneous cell population isolated from lipoaspirated fat via enzymatic or mechanical methods, and ASCs, a more homogeneous culture-expanded mesenchymal cell product, both exert regenerative effects through angiogenic, immunomodulatory, and reparative mechanisms. In OA, both cell types have been shown to significantly reduce pain and improve function, with some studies indicating cartilage regeneration on imaging. While ASCs may offer faster symptom relief due to higher purity and dosing, SVF remains a more accessible, minimally manipulated alternative with comparable long-term outcomes. In wound healing, adipose-derived therapies have been associated with accelerated closure of chronic ulcers through enhanced neovascularization, modulation of the inflammatory microenvironment, and promotion of granulation tissue and re-epithelialization. Across both indications, these therapies have shown a good safety profile, with minimal adverse events reported. The review also addresses regulatory distinctions, standardization challenges, and biologic variability, particularly in SVF preparations. Taken together, the evidence suggests the clinical utility of adipose-derived cellular therapies while highlighting the need for further standardization, long-term safety monitoring, and large-scale randomized trials to confirm efficacy and optimize clinical translation.

脂肪源性细胞疗法,包括基质血管组分(SVF)和脂肪源性干细胞(ASCs),已经在再生医学应用中显示出越来越大的治疗潜力。本文回顾了目前支持SVF和ASCs在两种主要临床情况下使用的证据:骨关节炎(OA)和慢性伤口愈合。SVF是一种通过酶或机械方法从抽脂脂肪中分离出来的异质细胞群,而ASCs是一种更均匀的培养扩增间充质细胞产物,两者都通过血管生成、免疫调节和修复机制发挥再生作用。在骨性关节炎中,这两种细胞类型都被证明可以显著减轻疼痛和改善功能,一些研究表明软骨再生在影像学上。虽然ASCs可能由于更高的纯度和剂量而提供更快的症状缓解,但SVF仍然是一种更容易获得、操作最少的替代方案,具有相当的长期结果。在伤口愈合中,脂肪衍生疗法通过增强新生血管、调节炎症微环境、促进肉芽组织和再上皮化,与慢性溃疡的加速愈合有关。在这两种适应症中,这些疗法显示出良好的安全性,不良事件报道最少。该综述还讨论了监管差异、标准化挑战和生物变异性,特别是SVF制剂。综上所述,这些证据表明脂肪源性细胞疗法具有临床实用性,同时强调需要进一步标准化、长期安全监测和大规模随机试验来确认疗效并优化临床转化。
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引用次数: 0
Clinical Status of Exosomes: A Review. 外泌体的临床研究进展。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-08-16 DOI: 10.1177/15563316251362179
Jonathan Sgaglione, Eric V Neufeld, Pooja Swami, Daniel A Grande

Nano-sized extracellular vesicles enclosed by a lipid bilayer and secreted by various cell types including mesenchymal stem cells, exosomes act as natural transporters, carrying bioactive molecules such as proteins, lipids, and nucleic acids that mediate intercellular communication. Exosomes influence a range of cellular processes, including immune modulation, tissue repair, and disease progression. Compared to whole-cell therapies, exosomes provide anti-inflammatory, immunosuppressive, and regenerative effects with reduced risks linked to cellular components, such as infusion toxicity, immunogenicity, and tumorigenic phenomena. This article reviews isolation, modification, characterization, and storage techniques, challenges in clinical translation, and innovative engineering strategies to enhance targeting and efficacy. It also examines preliminary evidence suggesting that exosomes may have potential in managing degenerative disorders such as osteoarthritis, intervertebral disc degeneration, osteoporosis, osteonecrosis, and tendinopathy, as well as non-degenerative disorders such as sciatic nerve injury, fractures, and soft tissue trauma.

外泌体是由脂质双分子层包裹的纳米级细胞外囊泡,由包括间充质干细胞在内的各种细胞类型分泌,作为天然转运体,携带生物活性分子,如蛋白质、脂质和介导细胞间通讯的核酸。外泌体影响一系列细胞过程,包括免疫调节、组织修复和疾病进展。与全细胞疗法相比,外泌体具有抗炎、免疫抑制和再生作用,降低了与细胞成分相关的风险,如输注毒性、免疫原性和致瘤现象。本文综述了分离、修饰、表征和储存技术,临床翻译中的挑战,以及提高靶向性和有效性的创新工程策略。它还检查了初步证据,表明外泌体可能在治疗退行性疾病(如骨关节炎、椎间盘退变、骨质疏松症、骨坏死和肌腱病)以及非退行性疾病(如坐骨神经损伤、骨折和软组织创伤)方面具有潜力。
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引用次数: 0
Evaluation of the Effect of Tranexamic Acid on Meniscus Healing and Articular Cartilage in a Rabbit Model. 氨甲环酸对兔半月板愈合及关节软骨影响的评价。
IF 1.3 4区 医学 Q3 ORTHOPEDICS Pub Date : 2025-08-11 DOI: 10.1177/15563316251357603
Jonathan Sgaglione, Janice Havasy, Ronak Patel, Ryan Healy, Vincent Yao, Yulei Liu, Ian Hutchinson, Michael Sama, Alexander Piacentini, Xianghua Deng, Scott Rodeo

Background: The formation of a stable fibrin clot plays an important role in early tissue repair. Tranexamic acid (TXA), a potent fibrinolysis inhibitor, prevents fibrin clot dissolution.

Purpose: We sought to test the effect of intra-articular TXA administration on meniscus healing and articular cartilage status in a rabbit model.

Methods: Thirty-two rabbits underwent bilateral knee surgery with creation of a 1.5-mm circular defect in the anterior horn of the lateral meniscus and a 3-mm longitudinal tear with repair in the anterior horn of the medial meniscus. Twelve rabbits were used for an initial TXA dose determination study. Twenty rabbits were then injected with 50 mg/mL of TXA in the left knee while the right knee served as a control. Animals were sacrificed at 2-, 4-, and 8-week timepoints. Eight rabbits underwent biomechanical analysis. Semiquantitative histological analysis compared meniscal healing and articular cartilage between TXA-treated and control knees.

Results: Both circular defects of the lateral meniscus and longitudinal tear injuries of the medial meniscus showed no difference in healing across all timepoints. At 2 weeks post-surgery, TXA-treated knees exhibited reduced tibial articular cartilage structure compared to controls. By week 8, control knees had higher proteoglycan content in all femoral articular cartilage zones compared to TXA-treated knees. Biomechanical analysis was inconclusive.

Conclusion: This rabbit study found that TXA administration did not enhance healing following meniscus repair. Moreover, intra-articular TXA appeared to have exerted an adverse effect on articular cartilage, possibly due to the detrimental effects of persistent blood in a joint. Further studies will be critically important to determine the effect of TXA administration at various time points after surgical repair.

背景:稳定的纤维蛋白凝块的形成在早期组织修复中起着重要作用。氨甲环酸(TXA),一种有效的纤维蛋白溶解抑制剂,防止纤维蛋白凝块溶解。目的:研究关节内给药TXA对兔半月板愈合和关节软骨状态的影响。方法:32只兔接受双侧膝关节手术,在外侧半月板前角形成1.5 mm的圆形缺损,在内侧半月板前角形成3 mm的纵向撕裂并修复。12只家兔用于初始TXA剂量测定研究。20只家兔左膝注射50 mg/mL的TXA,右膝作为对照。分别于第2周、第4周和第8周时间点处死动物。对8只家兔进行生物力学分析。半定量组织学分析比较半月板愈合和关节软骨在txa治疗和对照膝盖。结果:外侧半月板圆形缺损和内侧半月板纵向撕裂损伤的愈合在所有时间点上都没有差异。术后2周,与对照组相比,经txa治疗的膝关节表现出胫骨关节软骨结构的减少。到第8周,对照组膝关节与经txa治疗的膝关节相比,所有股骨关节软骨区蛋白多糖含量更高。生物力学分析尚无定论。结论:本家兔研究发现,给药TXA不能促进半月板修复后的愈合。此外,关节内的TXA似乎对关节软骨产生了不利影响,可能是由于关节内持续血液的有害影响。进一步的研究对于确定在手术修复后不同时间点给药TXA的效果至关重要。
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引用次数: 0
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