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Validation of Examination Maneuvers for Adolescent Idiopathic Scoliosis in the Telehealth Setting. 在远程医疗环境中验证青少年特发性脊柱侧凸的检查方法。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-10-02 DOI: 10.2106/JBJS.23.01146
Alexander R Farid, M Timothy Hresko, Semhal Ghessese, Gabriel S Linden, Stephanie Wong, Daniel Hedequist, Craig Birch, Danielle Cook, Kelsey Mikayla Flowers, Grant D Hogue

Background: Telehealth visits (THVs) have made it essential to adopt innovative ways to evaluate patients virtually. This study validates a novel THV approach that uses educational videos and an instructional datasheet, enabling parents to use smartphones to measure their child's scoliosis at home or in telehealth settings.

Methods: We identified a prospective cohort of patients with adolescent idiopathic scoliosis (AIS) scheduled for follow-up care from March to July 2021. The angle of trunk rotation (ATR) was first measured at home by patients' guardians using instructional video guidance and a smartphone application with internal accelerometer software. The second measurement was made during a THV examination performed by caregivers with supervision by trained associates via a telehealth appointment. Lastly, the clinician measured the child's ATR during an in-person clinic visit. Intraclass correlation coefficients (ICCs) and interrater reliability were compared between in-person clinic measurements and (1) at-home and (2) THV measurements. Shoulder, lower back, and pelvic asymmetry were observed and quantified at home and virtually, and then were compared with in-person clinic evaluations using kappa values. Surveys were used to evaluate the experience of the patient/caregiver with the at-home and telehealth assessment tools.

Results: Seventy-three patients were included (mean age, 14.1 years; 25% male). There was excellent agreement in the ATR measurements between THVs and in-person visits (ICC = 0.88; 95% confidence interval [CI] = 0.83 to 0.92). ATR agreement between at-home and in-person visits was also excellent, but slightly diminished (ICC = 0.76; 95% CI = 0.64 to 0.83). Agreement between THV and in-person measurements was significantly higher compared with that between at-home and in-person measurements (p = 0.04). There was poor agreement in lower back asymmetry between THV and in-person assessments (kappa = 0.37; 95% CI = 0.14 to 0.60); however, there was no significant agreement between at-home and in-person assessments (kappa = 0.06; 95% CI = -0.17 to 0.29). Patient/caregiver satisfaction surveys (n = 70) reported a median score of 4 ("good") for comfort with use of the technology, and a score of 3 ("neutral") for equivalence of THV and in-person evaluation.

Conclusions: There was a high level of agreement between telehealth and in-person spine measurements, suggesting that THVs may be reliably used to evaluate AIS, thus improving access to specialized care.

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

背景:远程医疗访问(THVs)使得采用创新方法对患者进行虚拟评估变得至关重要。本研究验证了一种新颖的THV方法,该方法使用教育视频和指导数据表,使家长能够在家中或远程医疗环境中使用智能手机测量孩子的脊柱侧凸:我们确定了一个青少年特发性脊柱侧弯症(AIS)患者前瞻性队列,这些患者计划在 2021 年 3 月至 7 月期间接受随访护理。躯干旋转角度(ATR)首先由患者监护人在家中通过视频指导和带有内置加速度计软件的智能手机应用程序进行测量。第二次测量是由护理人员在经过培训的同事监督下,通过远程医疗预约进行躯干旋转检查时进行的。最后,临床医生在亲自到诊所就诊时测量了患儿的 ATR。比较了面对面门诊测量与(1)在家测量和(2)THV 测量之间的类内相关系数(ICC)和交互可靠性。肩部、下背部和骨盆的不对称在家中和虚拟环境中进行了观察和量化,然后使用卡帕值与亲临诊所的评估结果进行比较。调查用于评估患者/护理人员使用居家和远程医疗评估工具的体验:共纳入 73 名患者(平均年龄 14.1 岁;25% 为男性)。远程健康评估与亲诊之间的 ATR 测量结果非常一致(ICC = 0.88;95% 置信区间 [CI] = 0.83 至 0.92)。家庭访问和亲自访问之间的 ATR 一致性也非常好,但略有降低(ICC = 0.76;95% 置信区间 [CI] = 0.64 至 0.83)。THV测量与当面测量之间的一致性明显高于居家测量与当面测量之间的一致性(p = 0.04)。在下背部不对称方面,THV 和亲自评估之间的一致性较差(kappa = 0.37;95% CI = 0.14 至 0.60);然而,在家评估和亲自评估之间没有明显的一致性(kappa = 0.06;95% CI = -0.17 至 0.29)。患者/护理人员满意度调查(n = 70)显示,技术使用舒适度的中位数为 4 分("良好"),THV 和亲自评估的等效性为 3 分("中性"):结论:远程医疗和现场脊柱测量的一致性很高,这表明 THV 可用于可靠地评估 AIS,从而改善专业护理的可及性:诊断级别 II。有关证据级别的完整描述,请参阅 "作者须知"。
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引用次数: 0
AOA Critical Issues Symposium: The Disruptive Physician: Bad Apple or Toxic Tree? AOA 关键问题研讨会:破坏性医生:坏苹果还是毒树?
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-10-02 DOI: 10.2106/JBJS.23.01262
Rey N Ramirez, Joel L Mayerson, Valerae O Lewis, Alan Friedman, Lisa Lattanza

Abstract: Disruptive physician behavior has become a common problem in medicine. Individuals who conduct themselves in a manner that could negatively affect patient care, or "disruptive physicians," frequently cause stress for patients and staff, are a headache for leadership, and can require expensive remediation. We suggest that rather than "bad apples," many disruptive physicians are the fruit of a "toxic tree." That is, many physicians only become disruptive as a response to their environment. It is important for leaders to accurately identify the root causes of disruptive behavior in order to address the problem. In general, it is important for leaders to act prospectively, to examine events from all perspectives, to promote wellness and communication, and to identify external or systemic causes. We also discuss additional considerations for when the physician who has been labeled "disruptive" is a member of an underrepresented group (in orthopaedic surgery, the underrepresented groups are women and racial minorities). As a conclusion, we offer a case example of how 1 institution established a system of physician wellness to enhance prevention efforts.

摘要:医生的破坏性行为已成为医学界的一个常见问题。行为方式可能对患者护理产生负面影响的个人,或称 "破坏性医生",经常给患者和员工造成压力,令领导层头疼不已,并可能需要昂贵的补救措施。我们认为,与其说许多破坏性医生是 "坏苹果",不如说他们是 "有毒树 "上结出的果实。也就是说,许多医生的破坏性行为只是对其所处环境的一种反应。领导者必须准确识别破坏性行为的根源,以便解决问题。一般来说,领导者必须采取前瞻性行动,从各个角度审视事件,促进健康和沟通,并找出外部或系统性原因。我们还讨论了当被贴上 "破坏性 "标签的医生属于代表性不足的群体(在骨科手术中,代表性不足的群体是女性和少数民族)时的其他注意事项。最后,我们提供了一个案例,说明一家机构是如何建立医生健康体系来加强预防工作的。
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引用次数: 0
The Cost-Effectiveness of Computer-Assisted Compared with Conventional Total Knee Arthroplasty: A Payer's Perspective. 计算机辅助全膝关节置换术与传统全膝关节置换术的成本效益比较:付款人的视角。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-04-25 DOI: 10.2106/JBJS.23.00555
Yao Tian, Abdalrahman G Ahmed, Annika N Hiredesai, Lynn Wei Huang, Ankita M Patel, Hassan M K Ghomrawi

Background: Recent evidence showing that computer-assisted total knee arthroplasty (TKA) is associated with better outcomes compared with conventional TKA for patients with end-stage knee osteoarthritis has not been included in economic evaluations of computer-assisted TKA, which are needed to support coverage decisions. This study evaluated the cost-effectiveness of computer-assisted TKA from a payer's perspective, incorporating recent evidence.

Methods: We compared computer-assisted TKA with conventional TKA with regard to costs (in 2022 U.S. dollars) and quality-adjusted life-years (QALYs) using Markov models for elderly patients (≥65 years of age) and patients who were not elderly (55 to 64 years of age). Costs and QALYs were estimated in the lifetime for elderly patients and in the short term for patients who were not elderly, under a bundled payment program and a Fee-for-Service program. Transition probabilities, costs, and QALYs were retrieved from the literature, a national knee arthroplasty registry, and the National Center for Health Statistics. Threshold and probabilistic sensitivity analyses were conducted to examine the robustness of key estimates used in the base-case analysis. Using projected estimates of TKA utilization, the total cost savings of performing computer-assisted TKA rather than conventional TKA were estimated.

Results: Compared with conventional TKA, computer-assisted TKA was associated with higher QALYs and lower costs for both elderly patients and patients who were not elderly, regardless of payment programs, making computer-assisted TKA a favorable treatment option. Widespread adoption of computer-assisted TKA in all U.S. patients would result in an estimated total cost saving of $1 billion for payers.

Conclusions: Compared with conventional TKA, computer-assisted TKA reduces costs to payers while providing favorable outcomes. Payers may consider providing additional payment incentives to providers for performing computer-assisted TKA, to achieve outcome improvement and cost control by facilitating widespread adoption of computer-assisted TKA.

Level of evidence: Economic and Decision Analysis Level II . See Instructions for Authors for a complete description of levels of evidence.

背景:最近有证据显示,与传统的膝关节骨性关节炎终末期患者全膝关节置换术(TKA)相比,计算机辅助全膝关节置换术(TKA)具有更好的疗效,但计算机辅助全膝关节置换术(TKA)的经济评价尚未纳入其中,而这是支持承保决策所必需的。本研究从支付方的角度评估了计算机辅助 TKA 的成本效益,并纳入了最新的证据:我们使用马尔可夫模型比较了计算机辅助 TKA 和传统 TKA 在老年患者(≥65 岁)和非老年患者(55 至 64 岁)方面的成本(2022 年美元)和质量调整生命年(QALYs)。在捆绑支付计划和收费服务计划下,对老年患者的终生成本和 QALY 进行了估算,并对非老年患者的短期成本和 QALY 进行了估算。过渡概率、成本和 QALYs 均来自文献、国家膝关节置换登记处和国家卫生统计中心。进行了阈值和概率敏感性分析,以检验基础案例分析中使用的关键估计值的稳健性。利用对 TKA 使用率的预测估算,估算了实施计算机辅助 TKA 而非传统 TKA 所节省的总成本:结果:与传统 TKA 相比,计算机辅助 TKA 可为老年患者和非老年患者带来更高的 QALYs 和更低的成本,无论支付方案如何,计算机辅助 TKA 都是一种有利的治疗选择。如果在所有美国患者中广泛采用计算机辅助TKA,估计可为支付方节省总成本10亿美元:结论:与传统的 TKA 相比,计算机辅助 TKA 在提供良好疗效的同时也降低了支付方的成本。支付方可考虑为实施计算机辅助 TKA 的医疗服务提供者提供额外的支付激励,通过促进计算机辅助 TKA 的广泛应用来实现疗效改善和成本控制:经济与决策分析 II 级。有关证据级别的完整描述,请参阅 "作者须知"。
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引用次数: 0
In Vivo Intra-Articular Antibiotic Concentrations at 24 Hours After TKA Fall Below the Minimum Inhibitory Concentration for Most Bacteria: A Randomized Study of Commercially Available Bone Cement. TKA 术后 24 小时体内关节内抗生素浓度低于大多数细菌的最低抑制浓度:对市售骨水泥的随机研究。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-07-25 DOI: 10.2106/JBJS.23.01412
Juan D Lizcano, Diana Fernández-Rodríguez, Graham S Goh, David E DeMik, Andrew J Hughes, Javad Parvizi, P Maxwell Courtney, James J Purtill, Matthew S Austin
<p><strong>Background: </strong>The use of antibiotic-loaded bone cement (ALBC) to help reduce the risk of infection after primary total knee arthroplasty (TKA) is controversial. There is a paucity of in vivo data on the elution characteristics of ALBC. We aimed to determine whether the antibiotic concentrations of 2 commercially available ALBCs met the minimum inhibitory concentration (MIC) and minimum biofilm eradication concentration (MBEC) for common infecting organisms.</p><p><strong>Methods: </strong>Forty-five patients undergoing TKA were randomized to receive 1 of the following: bone cement without antibiotic (the negative control; n = 5), a commercially available formulation containing 1 g of tobramycin (n = 20), or a commercially available formulation containing 0.5 g of gentamicin (n = 20). Intra-articular drains were placed, and fluid was collected at 4 and 24 hours postoperatively. An automated immunoassay measuring antibiotic concentration was performed, and the results were compared against published MIC and MBEC thresholds.</p><p><strong>Results: </strong>The ALBC treatment groups were predominantly of White (65%) or Black (32.5%) race and were 57.5% female and 42.4% male. The mean age (and standard deviation) was 72.6 ± 7.2 years in the gentamicin group and 67.6 ± 7.4 years in the tobramycin group. The mean antibiotic concentration in the tobramycin group was 55.1 ± 37.7 μg/mL at 4 hours and 19.5 ± 13.0 μg/mL at 24 hours, and the mean concentration in the gentamicin group was 38.4 ± 25.4 μg/mL at 4 hours and 17.7 ± 15.4 μg/mL at 24 hours. Time and antibiotic concentration had a negative linear correlation coefficient (r = -0.501). Most of the reference MIC levels were reached at 4 hours. However, at 24 hours, a considerable percentage of patients had concentrations below the MIC for many common pathogens, including Staphylococcus epidermidis (gentamicin: 65% to 100% of patients; tobramycin: 50% to 85%), methicillin-sensitive Staphylococcus aureus (gentamicin: 5% to 90%; tobramycin: 5% to 50%), methicillin-resistant S . aureus (gentamicin: 5% to 65%; tobramycin: 50%), Streptococcus species (gentamicin: 10% to 100%), and Cutibacterium acnes (gentamicin: 10% to 65%; tobramycin: 100%). The aforementioned ranges reflect variation in the MIC among different strains of each organism. Gentamicin concentrations reached MBEC threshold values at 4 hours only for the least virulent strains of S . aureus and Escherichia coli. Tobramycin concentrations did not reach the MBEC threshold for any of the bacteria at either time point.</p><p><strong>Conclusions: </strong>The elution of antibiotics from commercially available ALBC decreased rapidly following TKA, and only at 4 hours postoperatively did the mean antibiotic concentrations exceed the MIC for most of the pathogens. Use of commercially available ALBC may not provide substantial antimicrobial coverage following TKA.</p><p><strong>Level of evidence: </strong>Therapeutic Level I . See Instru
背景:使用抗生素骨水泥(ALBC)帮助降低初级全膝关节置换术(TKA)后的感染风险还存在争议。有关 ALBC 洗脱特性的体内数据很少。我们的目的是确定两种市售 ALBC 的抗生素浓度是否符合常见感染病菌的最小抑菌浓度 (MIC) 和最小生物膜根除浓度 (MBEC):45名接受TKA手术的患者被随机分为以下三种:不含抗生素的骨水泥(阴性对照;n = 5)、含1克妥布霉素的市售制剂(n = 20)或含0.5克庆大霉素的市售制剂(n = 20)。放置关节内引流管,并在术后 4 小时和 24 小时收集液体。采用自动免疫测定法测量抗生素浓度,并将结果与已公布的 MIC 和 MBEC 临界值进行比较:ALBC治疗组主要为白人(65%)或黑人(32.5%),女性占57.5%,男性占42.4%。庆大霉素组的平均年龄(和标准差)为 72.6 ± 7.2 岁,妥布霉素组为 67.6 ± 7.4 岁。妥布霉素组的平均抗生素浓度为 4 小时 55.1 ± 37.7 μg/mL,24 小时 19.5 ± 13.0 μg/mL;庆大霉素组的平均浓度为 4 小时 38.4 ± 25.4 μg/mL,24 小时 17.7 ± 15.4 μg/mL。时间与抗生素浓度呈负线性相关系数(r = -0.501)。大多数参考 MIC 水平在 4 小时内达到。金黄色葡萄球菌(庆大霉素:5%至 65%;妥布霉素:50%)、链球菌(庆大霉素:10%至 100%)和痤疮杆菌(庆大霉素:10%至 65%;妥布霉素:100%)。上述范围反映了每种生物不同菌株之间的 MIC 差异。只有毒性最低的金黄色葡萄球菌和大肠杆菌菌株的庆大霉素浓度在 4 小时后才达到 MBEC 临界值。妥布霉素的浓度在任何一个时间点都没有达到任何细菌的 MBEC 阈值:结论:TKA术后,市售ALBC中抗生素的洗脱率迅速下降,只有在术后4小时,大多数病原体的平均抗生素浓度才超过MIC。TKA术后使用市售ALBC可能无法提供实质性的抗菌保护:有关证据等级的完整描述,请参阅 "作者须知"。
{"title":"In Vivo Intra-Articular Antibiotic Concentrations at 24 Hours After TKA Fall Below the Minimum Inhibitory Concentration for Most Bacteria: A Randomized Study of Commercially Available Bone Cement.","authors":"Juan D Lizcano, Diana Fernández-Rodríguez, Graham S Goh, David E DeMik, Andrew J Hughes, Javad Parvizi, P Maxwell Courtney, James J Purtill, Matthew S Austin","doi":"10.2106/JBJS.23.01412","DOIUrl":"10.2106/JBJS.23.01412","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of antibiotic-loaded bone cement (ALBC) to help reduce the risk of infection after primary total knee arthroplasty (TKA) is controversial. There is a paucity of in vivo data on the elution characteristics of ALBC. We aimed to determine whether the antibiotic concentrations of 2 commercially available ALBCs met the minimum inhibitory concentration (MIC) and minimum biofilm eradication concentration (MBEC) for common infecting organisms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Forty-five patients undergoing TKA were randomized to receive 1 of the following: bone cement without antibiotic (the negative control; n = 5), a commercially available formulation containing 1 g of tobramycin (n = 20), or a commercially available formulation containing 0.5 g of gentamicin (n = 20). Intra-articular drains were placed, and fluid was collected at 4 and 24 hours postoperatively. An automated immunoassay measuring antibiotic concentration was performed, and the results were compared against published MIC and MBEC thresholds.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The ALBC treatment groups were predominantly of White (65%) or Black (32.5%) race and were 57.5% female and 42.4% male. The mean age (and standard deviation) was 72.6 ± 7.2 years in the gentamicin group and 67.6 ± 7.4 years in the tobramycin group. The mean antibiotic concentration in the tobramycin group was 55.1 ± 37.7 μg/mL at 4 hours and 19.5 ± 13.0 μg/mL at 24 hours, and the mean concentration in the gentamicin group was 38.4 ± 25.4 μg/mL at 4 hours and 17.7 ± 15.4 μg/mL at 24 hours. Time and antibiotic concentration had a negative linear correlation coefficient (r = -0.501). Most of the reference MIC levels were reached at 4 hours. However, at 24 hours, a considerable percentage of patients had concentrations below the MIC for many common pathogens, including Staphylococcus epidermidis (gentamicin: 65% to 100% of patients; tobramycin: 50% to 85%), methicillin-sensitive Staphylococcus aureus (gentamicin: 5% to 90%; tobramycin: 5% to 50%), methicillin-resistant S . aureus (gentamicin: 5% to 65%; tobramycin: 50%), Streptococcus species (gentamicin: 10% to 100%), and Cutibacterium acnes (gentamicin: 10% to 65%; tobramycin: 100%). The aforementioned ranges reflect variation in the MIC among different strains of each organism. Gentamicin concentrations reached MBEC threshold values at 4 hours only for the least virulent strains of S . aureus and Escherichia coli. Tobramycin concentrations did not reach the MBEC threshold for any of the bacteria at either time point.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The elution of antibiotics from commercially available ALBC decreased rapidly following TKA, and only at 4 hours postoperatively did the mean antibiotic concentrations exceed the MIC for most of the pathogens. Use of commercially available ALBC may not provide substantial antimicrobial coverage following TKA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Level of evidence: &lt;/strong&gt;Therapeutic Level I . See Instru","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"1664-1672"},"PeriodicalIF":4.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758981","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
Role of Gender in Health and Disease: Methods of Reporting and Interactions with Sex and Other Factors. 性别在健康和疾病中的作用:报告方法以及与性别和其他因素的相互作用。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-08-05 DOI: 10.2106/JBJS.24.00081
Londa Schiebinger

Abstract: Sex and gender are distinct terms that must be used correctly. Data regarding sex and gender may be collected using a 2-step method that separates biological sex and self-reported gender identity. The PhenX Toolkit, funded by the National Institutes of Health (NIH), is one tool that provides investigators with recommended standard data-collection protocols. Another tool is the Diversity Minimal Item Set questionnaire. Importantly, sex and gender interact: for example, pain has both biological aspects (sex differences in electrical, ischemic, thermal, pressure, and muscle pain sensitivity) and cultural aspects (gender factors in how people report pain and how physicians understand and treat pain in patients). Gender norms, identity, and relations all impact patient care. Gender norms, for instance, may influence how a person experiences pain, gender identity may influence a person's willingness to report pain, and gender relations may influence a physician's gendered expectations in relation to a patient's gendered behaviors. Clinicians may perceive women's pain to be psychological; as a result, women may receive more nonspecific diagnoses, wait longer for treatment, and receive more antidepressants and fewer analgesics than men. Research on gender-diverse people and pain is just now emerging. Resources for methods of reporting include The Lancet, Nature, and the Sex and Gender Equity in Research (SAGER) Guidelines. We must consider all relevant factors intersecting with sex and gender, including age, disabilities, educational background, ethnicity, family configuration, geographic location, race, sexuality, social and economic status, sustainability, and more.

摘要:性和性别是不同的术语,必须正确使用。有关性和性别的数据可采用两步法收集,即区分生物性别和自我报告的性别认同。由美国国立卫生研究院(NIH)资助的 PhenX 工具包就是一个为调查人员提供推荐标准数据收集协议的工具。另一个工具是多样性最小项目组问卷。重要的是,性和性别是相互影响的:例如,疼痛既有生物方面的因素(电、缺血、热、压力和肌肉疼痛敏感性方面的性别差异),也有文化方面的因素(人们如何报告疼痛以及医生如何理解和治疗患者疼痛方面的性别因素)。性别规范、身份和关系都会对患者护理产生影响。例如,性别规范可能会影响一个人如何体验疼痛,性别认同可能会影响一个人报告疼痛的意愿,性别关系可能会影响医生对病人性别行为的性别期望。临床医生可能会认为女性的疼痛是心理性的;因此,女性可能会比男性接受更多的非特异性诊断,等待治疗的时间更长,接受更多的抗抑郁药物和更少的镇痛药物。有关不同性别人群和疼痛的研究刚刚兴起。有关报告方法的资源包括《柳叶刀》、《自然》和《研究中的性别与性别平等 (SAGER) 指南》。我们必须考虑所有与性和性别交叉的相关因素,包括年龄、残疾、教育背景、种族、家庭结构、地理位置、种族、性别、社会和经济地位、可持续性等。
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引用次数: 0
The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research. 机构审查委员会在改善将性和性别作为变量纳入临床研究中的作用》(The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research.
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-08-01 DOI: 10.2106/JBJS.24.00211
Barbara E Bierer

Abstract: In orthopaedic clinical research, as in other fields, sex and gender-specific analyses are not consistently performed, despite evidence of sex differences in outcomes. Both institutional review boards (IRBs) and journal editors have a role in impacting the rate at which such analyses are performed and reported. The authority, responsibilities, and potential actions of IRBs are discussed herein, with the aim of setting investigator expectations and propelling changes to the study plan before the research is initiated.

摘要:与其他领域一样,在骨科临床研究中,尽管有证据表明结果存在性别差异,但并没有持续进行性别分析。机构审查委员会(IRB)和期刊编辑在影响此类分析的执行和报告速度方面都发挥着作用。本文讨论了机构审查委员会的权力、责任和可能采取的行动,目的是在研究开始前设定研究者的期望并推动研究计划的改变。
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引用次数: 0
What Are Social Determinants of Health and Why Should They Matter to an Orthopaedic Surgeon? 什么是健康的社会决定因素,为什么它们对矫形外科医生很重要?
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-04-18 DOI: 10.2106/JBJS.23.01114
Samantha S Meacock, Irfan A Khan, Alexandra L Hohmann, Anna Cohen-Rosenblum, Chad A Krueger, James J Purtill, Yale A Fillingham
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引用次数: 0
3D-Printed Metaphyseal Cones in Revision Total Knee Arthroplasties: Excellent Survivorship of 740 Cones at 5 Years. 翻修全膝关节置换术中的三维打印骺锥体:740 个锥体在 5 年后存活率极高。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-06-14 DOI: 10.2106/JBJS.23.01196
Christopher N Carender, Cole E Bothun, Michael J Taunton, Kevin I Perry, Nicholas A Bedard, Mark W Pagnano, Matthew P Abdel

Background: Porous metaphyseal cones are frequently utilized during revision total knee arthroplasty (TKA) procedures. The purpose of the present study was to evaluate 3D-printed metaphyseal cones used for revision TKA, with specific emphasis on implant survivorship, radiographic appearance, and clinical outcomes after short-term follow-up.

Methods: We identified 740 cones (498 tibial, 242 femoral) that had been inserted during 533 revision TKA procedures that had been performed at a single tertiary care academic institution. Aseptic loosening (n = 199), periprosthetic joint infection (PJI) (n = 183), and instability (n = 84) were the most common reasons for the index revision. Type-2B or 3 bone loss was present in 67% of the knees. The mean age was 66 years, the mean body mass index was 34 kg/m 2 , and 55% of the patients were female. Serial radiographs were reviewed. The mean duration of follow-up was 4 years.

Results: The 5-year cumulative incidence of cone revision for aseptic loosening was 1% (95% confidence interval [CI], 0% to 3%). The 5-year cumulative incidence of any cone revision or removal was 6% (95% CI, 4% to 9%). In total, 37 cones (19 femoral, 18 tibial) were revised, with PJI (n = 23; 14 recurrent), periprosthetic femoral fracture (n = 3), arthrofibrosis (n = 3), and aseptic loosening of the femoral component and femoral cone (n = 3) as the most common reasons for cone revision. The 5-year cumulative incidence of any TKA re-revision was 14% (95% CI, 11% to 18%). There were a total of 67 re-revisions, with PJI (n = 38), persistent drainage (n = 6), and extensor mechanism disruption (n = 3) being the most common reasons. Radiographically, 2 unrevised femoral cones and 1 unrevised tibial cone appeared to be possibly loose; all 3 cones were in knees with distal femoral replacements or hinged constructs.

Conclusions: This large series showed that 3D-printed titanium metaphyseal cones were very durable at short-term follow-up, with a 5-year cumulative incidence of cone revision for aseptic loosening of 1%. PJI was the most common reason for cone revision and any revision.

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

背景:多孔骺锥经常用于翻修全膝关节置换术(TKA)。本研究的目的是评估用于翻修 TKA 的 3D 打印骺锥体,重点是短期随访后的植入物存活率、放射学外观和临床效果:我们鉴定了在一家三级医疗学术机构进行的 533 例翻修 TKA 手术中植入的 740 个锥体(胫骨 498 个,股骨 242 个)。无菌性松动(199 例)、假体周围关节感染(PJI)(183 例)和不稳定性(84 例)是最常见的翻修原因。67%的膝关节存在2B型或3型骨质流失。平均年龄为66岁,平均体重指数为34 kg/m2,55%的患者为女性。患者均接受了连续的X光片检查。平均随访时间为4年:因无菌性松动而进行锥体翻修的5年累计发生率为1%(95%置信区间[CI],0%至3%)。任何锥体翻修或移除的 5 年累计发生率为 6%(95% 置信区间 [CI],4% 至 9%)。共有37个锥体(19个股骨锥体和18个胫骨锥体)进行了翻修,PJI(23个;14个复发)、股骨假体周围骨折(3个)、关节纤维化(3个)以及股骨组件和股骨锥体无菌性松动(3个)是锥体翻修的最常见原因。任何TKA再次翻修的5年累计发生率为14%(95% CI,11%至18%)。共有67例再次翻修,最常见的原因是PJI(38例)、持续引流(6例)和外展机构破坏(3例)。从X光片上看,2个未翻修的股骨锥体和1个未翻修的胫骨锥体似乎可能松动;这3个锥体均位于股骨远端置换或铰链结构的膝关节中:这一大型系列研究表明,3D打印钛骺锥体在短期随访中非常耐用,5年因无菌性松动而进行锥体翻修的累计发生率为1%。PJI是锥体翻修和任何翻修的最常见原因:证据级别:治疗四级。有关证据级别的完整描述,请参阅 "作者须知"。
{"title":"3D-Printed Metaphyseal Cones in Revision Total Knee Arthroplasties: Excellent Survivorship of 740 Cones at 5 Years.","authors":"Christopher N Carender, Cole E Bothun, Michael J Taunton, Kevin I Perry, Nicholas A Bedard, Mark W Pagnano, Matthew P Abdel","doi":"10.2106/JBJS.23.01196","DOIUrl":"10.2106/JBJS.23.01196","url":null,"abstract":"<p><strong>Background: </strong>Porous metaphyseal cones are frequently utilized during revision total knee arthroplasty (TKA) procedures. The purpose of the present study was to evaluate 3D-printed metaphyseal cones used for revision TKA, with specific emphasis on implant survivorship, radiographic appearance, and clinical outcomes after short-term follow-up.</p><p><strong>Methods: </strong>We identified 740 cones (498 tibial, 242 femoral) that had been inserted during 533 revision TKA procedures that had been performed at a single tertiary care academic institution. Aseptic loosening (n = 199), periprosthetic joint infection (PJI) (n = 183), and instability (n = 84) were the most common reasons for the index revision. Type-2B or 3 bone loss was present in 67% of the knees. The mean age was 66 years, the mean body mass index was 34 kg/m 2 , and 55% of the patients were female. Serial radiographs were reviewed. The mean duration of follow-up was 4 years.</p><p><strong>Results: </strong>The 5-year cumulative incidence of cone revision for aseptic loosening was 1% (95% confidence interval [CI], 0% to 3%). The 5-year cumulative incidence of any cone revision or removal was 6% (95% CI, 4% to 9%). In total, 37 cones (19 femoral, 18 tibial) were revised, with PJI (n = 23; 14 recurrent), periprosthetic femoral fracture (n = 3), arthrofibrosis (n = 3), and aseptic loosening of the femoral component and femoral cone (n = 3) as the most common reasons for cone revision. The 5-year cumulative incidence of any TKA re-revision was 14% (95% CI, 11% to 18%). There were a total of 67 re-revisions, with PJI (n = 38), persistent drainage (n = 6), and extensor mechanism disruption (n = 3) being the most common reasons. Radiographically, 2 unrevised femoral cones and 1 unrevised tibial cone appeared to be possibly loose; all 3 cones were in knees with distal femoral replacements or hinged constructs.</p><p><strong>Conclusions: </strong>This large series showed that 3D-printed titanium metaphyseal cones were very durable at short-term follow-up, with a 5-year cumulative incidence of cone revision for aseptic loosening of 1%. PJI was the most common reason for cone revision and any revision.</p><p><strong>Level of evidence: </strong>Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.</p>","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"1688-1696"},"PeriodicalIF":4.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141320966","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
Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study. 颈椎后路椎板切除术与颈椎前路椎间盘切除术加融合术治疗颈椎病的比较:FACET 随机非劣效性研究的两年结果。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-07-24 DOI: 10.2106/JBJS.23.00775
Nádia F Simões de Souza, Anne E H Broekema, Michiel F Reneman, Jan Koopmans, Henk van Santbrink, Mark P Arts, Bachtiar Burhani, Ronald H M A Bartels, Niels A van der Gaag, Martijn H P Verhagen, Katalin Tamási, J Marc C van Dijk, Rob J M Groen, Remko Soer, Jos M A Kuijlen
<p><strong>Background: </strong>Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery.</p><p><strong>Methods: </strong>This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536).</p><p><strong>Results: </strong>From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]).</p><p><strong>Conclusions: </strong>This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy.</p><p><strong>Lev
背景:颈椎后路椎板切除术(后路手术)是前路椎间盘切除加融合术(前路手术)的有效替代方案,可作为颈椎病的手术治疗方法,但证据质量有限。本研究的目的是比较这两种治疗方法在随访两年后的临床疗效。我们假设后路手术的疗效不会优于前路手术:这项多中心、随机、非劣效试验评估了荷兰9家医院的单级颈椎病患者,随访时间为2年。主要结果是根据奥多姆标准测量颈椎根性疼痛的减轻程度和成功率,以及用视觉模拟量表评估的臂痛和臂痛减轻程度,非劣效差为10%,即新疗法(后路手术)与标准疗法(前路手术)之间可接受的最大差异,超过这一差异,新疗法将被视为临床不可接受。次要结果包括颈部疼痛、颈部残疾指数、工作能力指数、生活质量、并发症(包括再次手术)和治疗满意度。分析采用了广义线性混合效应模型。该研究已在荷兰医学研究总署(OMON)注册,前身为荷兰试验注册中心(NTR5536):从2016年1月到2020年5月,265名患者被随机分配(132人分配到后路手术组,133人分配到前路手术组)。其中,25 名患者未接受分配的干预;这 25 名患者中有 11 名症状有所改善,其余患者因各种原因未接受干预。在为期两年的随访中,243 名患者中有 236 人(97%)获得了主要结果数据。后路手术和前路手术的成功预测比例分别为 0.81 和 0.74(成功率差异为-0.06 [单侧 95% 置信区间 (CI),-0.02]),表明后路手术的效果并不差。手臂疼痛的组间差异为-2.7(单侧 95% 置信区间,7.4),手臂疼痛减轻的组间差异为 1.5(单侧 95% 置信区间,8.2),均证实了后路手术的非劣效性。次要结果显示组间差异较小。接受后路手术的患者中有9人(8%)发生了严重的手术相关不良事件,其中9人再次手术,而接受前路手术的患者中有11人(9%)发生了严重的手术相关不良事件,其中7人再次手术(再次手术率的差异为-0.02 [2-sided 95% CI, -0.09 to 0.05]):该试验表明,经过2年的随访,后路手术在颈椎病患者的成功率和减轻手臂疼痛方面并不比前路手术差:有关证据等级的完整描述,请参阅 "作者须知"。
{"title":"Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study.","authors":"Nádia F Simões de Souza, Anne E H Broekema, Michiel F Reneman, Jan Koopmans, Henk van Santbrink, Mark P Arts, Bachtiar Burhani, Ronald H M A Bartels, Niels A van der Gaag, Martijn H P Verhagen, Katalin Tamási, J Marc C van Dijk, Rob J M Groen, Remko Soer, Jos M A Kuijlen","doi":"10.2106/JBJS.23.00775","DOIUrl":"10.2106/JBJS.23.00775","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Lev","PeriodicalId":15273,"journal":{"name":"Journal of Bone and Joint Surgery, American Volume","volume":" ","pages":"1653-1663"},"PeriodicalIF":4.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758983","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
Integrated Dual Lag Screws Have Higher Reoperation Rates for Fixation Failure Than Single Lag Component Cephalomedullary Nails: A Retrospective Study of 2,130 Patients with Intertrochanteric Femoral Fractures. 与单滞后组件头髓内钉相比,一体化双滞后螺钉的固定失败再手术率更高:对 2130 例股骨转子间骨折患者的回顾性研究。
IF 4.4 1区 医学 Q1 ORTHOPEDICS Pub Date : 2024-09-18 Epub Date: 2024-07-24 DOI: 10.2106/JBJS.23.01152
Christian A Gonzalez, Noelle L Van Rysselberghe, Mathew J Whittaker, Daniel Ngo, John B Michaud, Michael J Gardner

Background: Previous studies comparing reoperation risk between integrated dual lag screw (IDL) and single lag component (SL) cephalomedullary nails (CMNs) in the treatment of intertrochanteric femoral fractures have demonstrated mixed results. The purpose of this study was to assess the rates of reoperation for fixation failure and all-cause reoperation in a large, multi-institutional cohort of patients with an intertrochanteric fracture treated with an IDL or SL CMN. We hypothesized that there would be no difference between the groups with respect to either of the reoperation rates.

Methods: Adults (≥18 years old) who sustained an intertrochanteric fracture (AO/OTA 31A1 to 31A3) treated with an IDL or SL CMN between January 2014 and May 2021 at 1 of 13 Level-I trauma centers were included. Patients with <3 months of follow-up or pathologic fractures were excluded. Rates of reoperation were compared with use of the chi-square test and multivariable regression, controlling for age, gender, injury mechanism, fracture pattern, and postoperative neck-shaft angle.

Results: A total of 2,130 patients met the inclusion criteria. The median age was 78 years, and 62.5% of patients were female. The cohort consisted of 287 patients (13.5%) with an IDL CMN and 1,843 patients (86.5%) with an SL CMN. A total of 99 patients (4.6%) had a reoperation of any type, of whom 29 (1.4% of all patients) had a reoperation for fixation failure. Compared with patients with an SL CMN, those with an IDL CMN had higher rates (4.2% versus 0.9%; p < 0.001) and odds (odds ratio [OR], 4.95 [95% confidence interval (CI), 2.29 to 10.69]; p < 0.001) of reoperation for fixation failure as well as higher rates (7.3% versus 4.2%; p = 0.021) and odds (OR, 1.83 [95% CI, 1.10 to 3.06]; p = 0.021) of all-cause reoperation.

Conclusions: Intertrochanteric femoral fractures treated with an IDL CMN were associated with low but significantly higher rates and significantly higher odds of reoperation for fixation failure and all-cause reoperation compared with those treated with an SL CMN. We suggest caution to surgeons in the use of IDL CMNs for high-risk patients and recommend using SL CMNs for most patients with intertrochanteric femoral fractures.

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

背景:以往的研究比较了集成双滞后螺钉(IDL)和单滞后部件(SL)头髓内钉(CMN)治疗股骨转子间骨折的再手术风险,结果不一。本研究的目的是评估在使用 IDL 或 SL CMN 治疗股骨转子间骨折的大型多机构队列患者中,因固定失败而再次手术的比例以及因各种原因再次手术的比例。我们假设两组患者的再手术率没有差异:方法:纳入 2014 年 1 月至 2021 年 5 月期间在 13 个一级创伤中心中的 1 个中心接受 IDL 或 SL CMN 治疗的转子间骨折(AO/OTA 31A1 至 31A3)成人(≥18 岁)。患者与结果:共有 2130 名患者符合纳入标准。中位年龄为 78 岁,62.5% 的患者为女性。队列中包括 287 名 IDL CMN 患者(13.5%)和 1,843 名 SL CMN 患者(86.5%)。共有 99 名患者(4.6%)进行过任何类型的再次手术,其中 29 人(占所有患者的 1.4%)因固定失败而再次手术。与 SL CMN 患者相比,IDL CMN 患者因固定失败而再次手术的比例(4.2% 对 0.9%;P < 0.001)和几率(几率比 [OR],4.95 [95% 置信区间 (CI),2.29 对 10.69];P < 0.001),因固定失败而再次手术的比例(7.3% 对 4.2%;P = 0.021)和全因再次手术的几率(OR,1.83 [95% CI,1.10 对 3.06];P = 0.021)也更高:结论:与使用SL CMN治疗的股骨转子间骨折相比,使用IDL CMN治疗的股骨转子间骨折的固定失败率和全因再手术的几率较低,但明显较高。我们建议外科医生慎用IDL CMN治疗高风险患者,并建议大多数股骨转子间骨折患者使用SL CMN:治疗级别 III。有关证据级别的完整描述,请参阅 "作者须知"。
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Journal of Bone and Joint Surgery, American Volume
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