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Head, Hands, and Heart. 头,手,心。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.25.00021
Manuel García-Aríz, Claribel Rivera-Torres, José I Acosta-Julbe
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引用次数: 0
Five-Year Radiographic and Clinical Outcomes of Pyrocarbon Hemiarthroplasty for Glenohumeral Arthritis and Osteonecrosis. 炭素半关节置换术治疗盂肱关节炎和骨坏死的5年影像学和临床疗效。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.25.00163
B Gage Griswold, Jean Marie Berger, Brian P Davis, Libby Mauter, Mallory Boyd, Hayden B Schuette, Peter S Johnston, Benjamin W Sears, Armodios M Hatzidakis

Background: This study evaluated the progression of humeral head medialization in patients who underwent pyrocarbon hemiarthroplasty (PyC-HA). The authors hypothesized that glenoid erosion would not dramatically progress between the short-term and final imaging evaluations, and that there would be excellent clinical outcomes at ≥5-year follow-up.

Methods: Patients who underwent PyC-HA with ≥60 months of follow-up were included in this prospective study. Relevant data included preoperative demographic characteristics, Walch glenoid classification, changes in clinical outcomes, and revision-free and failure-free survival rates. An investigator, who was blinded to patient outcomes, assessed the glenoid morphology, changes in medialization, joint space, acromiohumeral distance (AHD), critical shoulder and β angles, and posterior subluxation in decentered glenoids at the 2-year and final follow-up visits.

Results: Forty-five patients with a mean age of 52 years and a mean follow-up of 73 months met the inclusion criteria. Significant improvements were observed across all outcome measures. The 7-year revision-free survival rate was 95.7%. Posterior subluxation in decentered shoulders decreased from 27.1% preoperatively to 19.8% postoperatively (p = 0.008). The mean medialization of the humeral head was 2.9 ± 2.8 mm at the 2-year follow-up and increased to 4.0 ± 3.3 mm at the time of the final follow-up (p = 0.096). A >2-mm decrease in AHD from early postoperative to final imaging was observed in 82.2% of patients (p < 0.001). All other radiographic changes were not significant.

Conclusions: PyC-HA is a reliable procedure for treating glenohumeral joint disease, demonstrating excellent clinical outcomes and stabilized glenoid morphology in the majority of patients between the 2-year and intermediate-term follow-up.

Level of evidence: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.

背景:本研究评估了接受热炭半关节置换术(PyC-HA)患者肱骨头内侧化的进展。作者假设关节盂糜烂在短期和最终影像学评估之间不会有显著的进展,并且在≥5年的随访中将有很好的临床结果。方法:接受PyC-HA治疗并随访≥60个月的患者纳入本前瞻性研究。相关数据包括术前人口学特征、Walch关节盂分类、临床结果的变化、无修复和无失败生存率。一名对患者结局不知情的研究者在2年和最后一次随访时评估了关节盂形态、内侧化变化、关节间隙、肩肱骨距离(AHD)、临界肩角和β角以及偏心关节盂后侧半脱位。结果:45例患者符合纳入标准,平均年龄52岁,平均随访73个月。在所有结果测量中观察到显著的改善。7年无修正生存率为95.7%。离心肩部后路半脱位从术前的27.1%下降到术后的19.8% (p = 0.008)。2年随访时肱骨头平均内侧化为2.9±2.8 mm,最终随访时增加到4.0±3.3 mm (p = 0.096)。82.2%的患者从术后早期到最终显像期间AHD下降>.2 mm (p < 0.001)。其他影像学改变均不显著。结论:PyC-HA是治疗肩关节疾病的可靠方法,在2年至中期随访期间,大多数患者表现出良好的临床效果和稳定的肩关节形态。证据等级:治疗性II级。有关证据水平的完整描述,请参见作者说明。
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引用次数: 0
Bezeotermin Alfa (rhBMP-6) Administration in Lumbar Interbody Fusion Surgery Using a Posterior Approach: A Randomized, Double-Blinded, Placebo-Controlled Phase-2 Study. 后路腰椎椎间融合术中给予Bezeotermin α (rhBMP-6):一项随机、双盲、安慰剂对照的2期研究
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-17 DOI: 10.2106/JBJS.25.00424
Weishi Li, Xiaoji Luo, Xiaozhong Zhou, Bo Liu, Huilin Yang, Liangbin Gao, Juan Zhang Ke, Wanling Liang, Zhongzhou Xiao, Yidan Zhang, Hua Zhu Ke, Slobodan Vukičević, Yilong Zhang, Mark Pahuta, Ricardo Dent-Acosta

Background: Novel osteoconductive and osteoinductive therapies for posterior-based lumbar interbody fusion surgery are needed. Bezeotermin alfa (recombinant human bone morphogenetic protein [rhBMP]-6, previously referred to as AGA111) is a potential potent stimulator of bone regeneration. This prospective, multicenter, randomized, double-blinded, placebo-controlled Phase-2 trial evaluated the safety and preliminary efficacy of bezeotermin carried by autologous blood coagulum (ABC) in patients undergoing lumbar interbody fusion surgery between L3 and S1 for degenerative disc disease.

Methods: Adult patients scheduled for single-level elective lumbar interbody fusion surgery across 6 clinical trial sites in the People's Republic of China were randomized 1:1:1 to placebo, 0.25 mg bezeotermin, or 0.5 mg bezeotermin and followed for 12 months. The primary end point was the incidence of adverse events (AEs). Secondary end points included anti-rhBMP-6 antibodies, the success rate of radiographic fusion, changes in the Oswestry Disability Index (ODI) score, changes in the pain score on a visual analogue scale (VAS), and serum drug concentrations.

Results: Sixty-three patients with a mean age of 59.2 years (52% female, 98.4% Han) were enrolled in the study. Twenty-one, 20, and 22 of the patients were randomized to placebo, 0.25 mg bezeotermin, and 0.5 mg bezeotermin, respectively. All patients reported at least 1 AE during the study, but most AEs were mild to moderate in severity. No drug-related serious AEs were reported in the bezeotermin groups. There was a trend toward a higher rate of successful radiographic fusion and greater improvement of the ODI and VAS scores in the bezeotermin groups than in the placebo group from month 3 to month 12.

Conclusions: This prospective, randomized, double-blinded, placebo-controlled trial demonstrated that bezeotermin/ABC was safe and well tolerated during posterior-based single-level lumbar interbody fusion. The preliminary efficacy of bezeotermin in accelerating spinal fusion and improving clinical outcomes supports its further clinical development.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

背景:后路腰椎椎体间融合手术需要新的骨传导和骨诱导疗法。重组人骨形态发生蛋白[rhBMP]-6,以前称为AGA111,是一种潜在的强效骨再生刺激剂。这项前瞻性、多中心、随机、双盲、安慰剂对照的ii期临床试验评估了自体凝血(ABC)携带bezeotermin用于L3和S1间腰椎椎体间融合手术治疗退行性椎间盘疾病患者的安全性和初步疗效。方法:计划在中华人民共和国6个临床试验点进行单节段择期腰椎椎体间融合手术的成年患者以1:1:1的比例随机分配到安慰剂、0.25 mg贝西莫特明或0.5 mg贝西莫特明,随访12个月。主要终点是不良事件(ae)的发生率。次要终点包括抗rhbmp -6抗体、放射融合成功率、Oswestry残疾指数(ODI)评分变化、视觉模拟评分(VAS)疼痛评分变化和血清药物浓度。结果:63例患者入组,平均年龄59.2岁,其中女性52%,汉族98.4%。21名、20名和22名患者分别被随机分配到安慰剂、0.25 mg和0.5 mg bezeotermin组。在研究期间,所有患者都报告了至少1次AE,但大多数AE的严重程度为轻度至中度。在贝西特明组中未报告与药物相关的严重不良事件。从第3个月到第12个月,与安慰剂组相比,bezeotermin组有更高的放射融合成功率和更大的ODI和VAS评分改善的趋势。结论:这项前瞻性、随机、双盲、安慰剂对照试验表明,bezeotermin/ABC在后路单节段腰椎椎体间融合术中是安全且耐受性良好的。bezeotermin在加速脊柱融合和改善临床结果方面的初步疗效支持其进一步的临床开发。证据水平:治疗性i级。参见《作者说明》获得证据水平的完整描述。
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引用次数: 0
Medical Malpractice Litigation in Orthopaedic Surgery in the United States: Risk Factors, Outcomes, and Strategies for Navigating Lawsuits, Prevention, and Reform. 美国整形外科的医疗事故诉讼:风险因素、结果和诉讼导航策略、预防和改革。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-18 DOI: 10.2106/JBJS.25.00394
Peter Boufadel, Diane Ghanem, Mohammad Daher, Adam Rizk, Joyce D Suarez, Caroline B Granruth, Mohamad Y Fares, Karan Goswami, Daniel E Goltz, Alexander R Vaccaro, Joseph A Abboud

➢ Medical malpractice litigation in orthopaedic surgery remains a major challenge, as the field consistently ranks among the most frequently litigated specialties. Malpractice claims in orthopaedics often involve surgical errors, misdiagnoses, delayed treatment, and inadequate postoperative care, with substantial financial and emotional consequences for health-care providers.➢ Malpractice risk varies by orthopaedic subspecialty, with adult reconstruction and spine surgeons facing the highest litigation rates, often due to nerve injuries, delayed or missed diagnoses, or postoperative complications. Although defense verdicts are the most common outcome, substantial settlements and plaintiff verdicts occur in cases involving irreversible damages, inadequate informed consent, or technical errors.➢ Proactive risk management and legal preparedness can help to mitigate liability and protect physicians. Preventative strategies include clear, supportive communication to build patient trust, comprehensive documentation ensuring adherence to evidence-based guidelines, and diagnostic accuracy through use of objective tools.

整形外科领域的医疗事故诉讼仍然是一项重大挑战,因为该领域一直是最常见的诉讼专业之一。骨科的医疗事故索赔通常涉及手术失误、误诊、延误治疗和术后护理不足,给医疗保健提供者带来重大的经济和情感后果。医疗事故风险因骨科亚专科而异,成人重建和脊柱外科医生面临的诉讼率最高,通常是由于神经损伤、延迟或漏诊或术后并发症。尽管被告判决是最常见的结果,但实质性和解和原告判决也会发生在涉及不可逆转损害、不充分知情同意或技术错误的案件中。(四)积极主动的风险管理和法律准备有助于减轻责任和保护医生。预防策略包括明确的、支持性的沟通,以建立患者的信任,确保遵守循证指南的全面文件,以及通过使用客观工具来准确诊断。
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引用次数: 0
What's New in Musculoskeletal Basic Science. 肌肉骨骼基础科学的新进展。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.25.01234
Chelsea S Bahney, Martin J Stoddart, Theodore Miclau, Ralph S Marcucio
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引用次数: 0
The Urgent Need for Musculoskeletal Risk Research in Youth Concussion Protocols. 青少年脑震荡方案中肌肉骨骼风险研究的迫切需要。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-18 DOI: 10.2106/JBJS.25.00387
Justin Hyde
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引用次数: 0
Postoperative Abstinence Restores Osseointegration Impaired by Ethanol Consumption in a Murine Tibial Implant Model. 在小鼠胫骨植入物模型中,术后戒断可恢复乙醇消耗导致的骨整合损伤。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.25.00517
Kevin Döring, Andrew L Thomson, Vincentius Suhardi, Qingdian Li, Anastasia Oktarina, Lionel Ivashkiv, Matthew Greenblatt, Reinhard Windhager, Mathias P Bostrom, Xu Yang

Background: Alcohol negatively affects bone health and fracture repair, yet its effects on implant osseointegration remain poorly understood. This in vivo study utilized a previously developed murine model to evaluate implant osseointegration before and after continuous ethanol consumption.

Methods: Adult mice were given regular drinking water (control group) or 10% to 15% ethanol in their drinking water for 3 months before undergoing surgical implantation of a load-bearing, porous titanium implant in the proximal tibia. Ethanol consumption was continued until euthanasia at 4 weeks post-implantation (ethanol group) or stopped immediately post-implantation (abstinence group) to mimic postoperative ethanol cessation. Osseointegration was assessed using micro-computed tomography (micro-CT), biomechanical pullout testing, and histological analysis.

Results: Mice with continuous ethanol consumption exhibited significantly reduced peri-implant bone formation, as measured with histology and micro-CT, compared with controls. Biomechanical testing demonstrated a weaker bone-implant interface in the ethanol group compared with controls. In contrast, postoperative abstinence restored the peri-implant bone formation and bone-implant interface strength to levels similar to those in the control group.

Conclusions: Ethanol consumption compromised implant osseointegration in mice, while postoperative abstinence promoted the recovery of peri-implant bone formation and interface strength.

Clinical relevance: Future clinical studies are needed to assess the impact of preoperative and postoperative abstinence of ethanol on osseointegration of orthopaedic implants.

背景:酒精对骨健康和骨折修复有负面影响,但其对种植体骨整合的影响尚不清楚。这项体内研究利用先前开发的小鼠模型来评估连续乙醇消耗前后种植体骨整合。方法:成年小鼠定期饮水(对照组)或饮水中添加10% ~ 15%乙醇3个月后,在胫骨近端植入承重多孔钛种植体。乙醇消耗量持续到植入后4周安乐死(乙醇组),或在植入后立即停止(戒断组),以模拟术后停止使用乙醇。采用显微计算机断层扫描(micro-CT)、生物力学拔出试验和组织学分析评估骨整合。结果:与对照组相比,通过组织学和显微ct测量,连续饮用乙醇的小鼠表现出明显减少种植体周围骨形成。生物力学测试表明,与对照组相比,乙醇组的骨-植入物界面较弱。相比之下,术后戒断使种植体周围骨形成和骨-种植体界面强度恢复到与对照组相似的水平。结论:乙醇消耗损害了小鼠种植体骨整合,而术后戒酒促进了种植体周围骨形成和界面强度的恢复。临床相关性:需要进一步的临床研究来评估术前和术后戒酒对骨科种植体骨整合的影响。
{"title":"Postoperative Abstinence Restores Osseointegration Impaired by Ethanol Consumption in a Murine Tibial Implant Model.","authors":"Kevin Döring, Andrew L Thomson, Vincentius Suhardi, Qingdian Li, Anastasia Oktarina, Lionel Ivashkiv, Matthew Greenblatt, Reinhard Windhager, Mathias P Bostrom, Xu Yang","doi":"10.2106/JBJS.25.00517","DOIUrl":"10.2106/JBJS.25.00517","url":null,"abstract":"<p><strong>Background: </strong>Alcohol negatively affects bone health and fracture repair, yet its effects on implant osseointegration remain poorly understood. This in vivo study utilized a previously developed murine model to evaluate implant osseointegration before and after continuous ethanol consumption.</p><p><strong>Methods: </strong>Adult mice were given regular drinking water (control group) or 10% to 15% ethanol in their drinking water for 3 months before undergoing surgical implantation of a load-bearing, porous titanium implant in the proximal tibia. Ethanol consumption was continued until euthanasia at 4 weeks post-implantation (ethanol group) or stopped immediately post-implantation (abstinence group) to mimic postoperative ethanol cessation. Osseointegration was assessed using micro-computed tomography (micro-CT), biomechanical pullout testing, and histological analysis.</p><p><strong>Results: </strong>Mice with continuous ethanol consumption exhibited significantly reduced peri-implant bone formation, as measured with histology and micro-CT, compared with controls. Biomechanical testing demonstrated a weaker bone-implant interface in the ethanol group compared with controls. In contrast, postoperative abstinence restored the peri-implant bone formation and bone-implant interface strength to levels similar to those in the control group.</p><p><strong>Conclusions: </strong>Ethanol consumption compromised implant osseointegration in mice, while postoperative abstinence promoted the recovery of peri-implant bone formation and interface strength.</p><p><strong>Clinical relevance: </strong>Future clinical studies are needed to assess the impact of preoperative and postoperative abstinence of ethanol on osseointegration of orthopaedic implants.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2774-2779"},"PeriodicalIF":4.3,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is It Enough? Disclosure of Medical Industry Payments to Orthopaedic Surgery Journal Editors and the Need for Transparency. 够了吗?医疗行业向骨科杂志编辑付款的披露及其透明度的必要性。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.24.01623
Daniel L Riddle

Background: Financial conflicts of interest (COIs) are arguably a powerful form of COI in scientific journal publishing. The purposes of this paper were to explore the financial COIs of the 6 most highly ranked U.S.-based orthopaedic surgery journals, to more thoroughly examine financial COIs in the journal with the highest industry payments, and to discuss possible approaches to mitigating the potential negative impact of financial COIs.

Methods: Two publicly available sources of data were used to characterize editor industry funding: the websites or mastheads of high-impact U.S.-based journals and the Open Payments database from the Centers for Medicare & Medicaid Services.

Results: From 2021 to 2023, the median General and Research Payments per editor varied substantially, from a low of $0 to Clinical Orthopaedics and Related Research editors to $2,735,566 to The Journal of Arthroplasty editors.

Conclusions: Financial COIs existed for some editors at each of the 6 most highly ranked U.S.-based orthopaedic surgery journals. For The Journal of Arthroplasty, the sixth-highest-ranking journal, the majority of the editors and editorial board members had financial COIs. Adverse journal consequences related to financial COIs could be mitigated by enhancing the transparency of disclosures and prominently displaying journal policies for handling COIs on journal websites.

背景:经济利益冲突(COI)可以说是科学期刊出版中强有力的COI形式。本文的目的是探讨6种排名最高的美国骨科外科期刊的财务coi,更彻底地检查行业报酬最高的期刊的财务coi,并讨论减轻财务coi潜在负面影响的可能方法。方法:使用两个公开可用的数据来源来描述编辑行业资金:美国高影响力期刊的网站或报头以及医疗保险和医疗补助服务中心的开放支付数据库。结果:从2021年到2023年,每位编辑的一般和研究报酬中位数变化很大,从临床骨科和相关研究编辑的低至0美元到关节成形术杂志编辑的2,735,566美元。结论:在美国排名最高的6种骨科外科期刊中,存在一些编辑的财务coi。排名第六的《关节成形术杂志》(The Journal of Arthroplasty)的大多数编辑和编委会成员都有财务coi。通过提高披露的透明度和在期刊网站上突出显示期刊处理coi的政策,可以减轻与财务coi相关的不利期刊后果。
{"title":"Is It Enough? Disclosure of Medical Industry Payments to Orthopaedic Surgery Journal Editors and the Need for Transparency.","authors":"Daniel L Riddle","doi":"10.2106/JBJS.24.01623","DOIUrl":"10.2106/JBJS.24.01623","url":null,"abstract":"<p><strong>Background: </strong>Financial conflicts of interest (COIs) are arguably a powerful form of COI in scientific journal publishing. The purposes of this paper were to explore the financial COIs of the 6 most highly ranked U.S.-based orthopaedic surgery journals, to more thoroughly examine financial COIs in the journal with the highest industry payments, and to discuss possible approaches to mitigating the potential negative impact of financial COIs.</p><p><strong>Methods: </strong>Two publicly available sources of data were used to characterize editor industry funding: the websites or mastheads of high-impact U.S.-based journals and the Open Payments database from the Centers for Medicare & Medicaid Services.</p><p><strong>Results: </strong>From 2021 to 2023, the median General and Research Payments per editor varied substantially, from a low of $0 to Clinical Orthopaedics and Related Research editors to $2,735,566 to The Journal of Arthroplasty editors.</p><p><strong>Conclusions: </strong>Financial COIs existed for some editors at each of the 6 most highly ranked U.S.-based orthopaedic surgery journals. For The Journal of Arthroplasty, the sixth-highest-ranking journal, the majority of the editors and editorial board members had financial COIs. Adverse journal consequences related to financial COIs could be mitigated by enhancing the transparency of disclosures and prominently displaying journal policies for handling COIs on journal websites.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2718-2723"},"PeriodicalIF":4.3,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Human Carpentry: Exploring the Parallels Between Orthopaedic Surgery and Woodworking. 人类木工:探索骨科手术和木工之间的相似之处。
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.25.00772
Charu Jain, Andrew C Hecht, Paul A Anderson
{"title":"Human Carpentry: Exploring the Parallels Between Orthopaedic Surgery and Woodworking.","authors":"Charu Jain, Andrew C Hecht, Paul A Anderson","doi":"10.2106/JBJS.25.00772","DOIUrl":"10.2106/JBJS.25.00772","url":null,"abstract":"","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"2711-2717"},"PeriodicalIF":4.3,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Randomized Controlled Trial of a Conventional Versus Modular Dual-Mobility Bearing: Are Serum Metal Levels a Concern? 传统与模块化双活动度轴承的随机对照试验:血清金属水平是否有影响?
IF 4.3 1区 医学 Q1 ORTHOPEDICS Pub Date : 2025-12-17 Epub Date: 2025-11-13 DOI: 10.2106/JBJS.24.01479
Anne DeBenedetti, Matthew T Weintraub, Anastasia Skipor, Craig J Della Valle, Joshua J Jacobs, Denis Nam

Background: The primary purpose of this randomized controlled trial was to evaluate serum metal levels in patients after total hip arthroplasty (THA) with a conventional compared with a modular dual-mobility bearing. The secondary aim was to compare patient-reported outcome measure (PROM) scores between the 2 cohorts.

Methods: Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral components and a ceramic femoral head. Serum cobalt and chromium levels were measured preoperatively and annually at 1 through 5 years postoperatively. A total of 53 patients were enrolled. The 2 cohorts did not differ significantly in terms of demographics. In the conventional-bearing cohort, 76% of the patients were White and 24% were Black, African American; 48% of the patients were male and 52% were female. In the dual-mobility cohort, 86% of the patients were White and 14% were Black, African American; 79% of the patients were male and 21% were female.

Results: Forty-one patients who were randomized to a modular dual-mobility (n = 24) or conventional (n = 17) bearing and had a minimum follow-up of 2 years underwent serum metal analysis. No differences in serum cobalt levels (mean, 0.14 ng/mL [range, 0.075 to 0.29 ng/mL] versus 0.21 ng/mL [range, 0.075 to 0.57 ng/mL]; p = 0.22) or chromium levels (mean, 0.14 ng/mL [range, 0.05 to 0.50 ng/mL] versus 0.12 ng/mL [range, 0.05 to 0.35 ng/mL]; p = 0.65) were identified between the modular dual-mobility and conventional cohorts, respectively, at the 2-year postoperative time point.

Conclusions: There were no significant differences in serum cobalt or chromium levels at 1 and 2 years postoperatively in patients who received a ceramic femoral head and this specific dual-mobility bearing compared with a ceramic head and a conventional acetabular component. While modest expected elevations in postoperative relative to preoperative serum cobalt and chromium levels were observed in the dual-mobility group, in no case did the cobalt level exceed the laboratory reference range or the threshold of 1 ng/mL that has been associated with adverse local tissue reactions due to mechanically assisted crevice corrosion.

Level of evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

背景:本随机对照试验的主要目的是评估全髋关节置换术(THA)后使用常规和模块化双活动轴承患者的血清金属水平。次要目的是比较两组患者报告的预后指标(PROM)评分。方法:接受骨关节炎原发性THA的患者随机接受模块化双活动或常规聚乙烯轴承。所有患者均接受相同的钛髋臼和股骨假体以及陶瓷股骨头。术前及术后1 ~ 5年每年测定血清钴、铬水平。共有53名患者入组。这两个队列在人口统计学方面没有显著差异。在传统生育队列中,76%的患者是白人,24%是黑人,非裔美国人;男性占48%,女性占52%。在双活动队列中,86%的患者是白人,14%是黑人,非裔美国人;男性占79%,女性占21%。结果:41名患者随机分为模块化双活动轴承组(n = 24)和常规轴承组(n = 17),随访时间至少为2年,进行血清金属分析。术后2年时间点,模块化双迁移组和常规组血清钴水平(平均0.14 ng/mL[范围,0.075至0.29 ng/mL] vs 0.21 ng/mL[范围,0.075至0.57 ng/mL], p = 0.22)和铬水平(平均0.14 ng/mL[范围,0.05至0.50 ng/mL] vs 0.12 ng/mL[范围,0.05至0.35 ng/mL], p = 0.65)均无差异。结论:与陶瓷股骨头和传统髋臼组件相比,接受陶瓷股骨头和这种特殊的双活动轴承的患者术后1年和2年的血清钴或铬水平无显著差异。虽然在双流动性组中观察到术后血清钴和铬水平相对于术前有适度的预期升高,但在任何情况下,钴水平均未超过实验室参考范围或1 ng/mL的阈值,该阈值与机械辅助缝隙腐蚀引起的局部组织不良反应有关。证据水平:治疗性i级。参见《作者说明》获得证据水平的完整描述。
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引用次数: 0
期刊
Journal of Bone and Joint Surgery, American Volume
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