custom-made implant

定制植入物
  • 文章类型: Journal Article
    背景:重建颅面-颌面缺损存在重大挑战。这项研究评估了聚醚醚酮患者特异性植入物(PEEKPSIs)在原发性和继发性颅面重建中的结果,重点关注美学和功能结果以及长期并发症。
    方法:从2009年10月至2023年2月,45例患者接受了PSIs颅面重建。18岁或以上的患者,至少随访12个月,包括在内。通过改良的Katsuragy量表评估形态功能结局,疼痛的视觉模拟评分(VAS),和四个FACE-Q|美学©量表。
    结果:总计,在37例患者中放置了44个PSI(男性占51.3%;平均年龄45.1岁)。缺损的主要原因是肿瘤切除(55.4%)。平均随访时间为78.6个月。临床评估显示术后患者和外科医生评分均有所改善(分别为p:0.01和p:0.002)。亚组分析证实,接受颅骨成形术(p=0.02)和下颌骨重建(p=0.03)的患者显着改善。无假体脱位病例,破裂,或记录长期感染。
    结论:PEEKPSIs在颅面重建中具有显著优势。尽管在预测软组织适应方面存在挑战,患者总体满意度高,无长期并发症.未来的改进应该集中在预测和增强软组织适应性上。
    BACKGROUND: Reconstructing cranio-maxillo-facial defects presents significant challenges. This study evaluates the results of polyetheretherketone patient-specific implants (PEEK PSIs) in primary and secondary cranio-maxillo-facial reconstructions, with a focus on aesthetic and functional outcomes and long-term complications.
    METHODS: From October 2009 to February 2023, 45 patients underwent cranio-maxillo-facial reconstructions with PSIs. Patients aged 18 years or older, with a minimum follow-up period of 12 months, were included. The morpho-functional outcome was evaluated through a modified Katsuragy Scale, the Visual Analogue Scale (VAS) for pain, and four FACE-Q|Aesthetics© scales.
    RESULTS: In total, 44 PSIs were placed in 37 patients (51.3% males; mean age 45.1 years). The main cause of the defect was the resection of a tumor (55.4%). Mean follow-up was 78.6 months. Clinical evaluations showed an improvement in the postoperative period both in patient\'s and surgeon\'s scores (p: 0.01 and p: 0.002, respectively). Subgroup analysis confirmed a significant improvement in patients undergoing cranioplasty (p = 0.02) and mandible reconstruction (p = 0.03). No cases of prosthesis dislocation, rupture, or long-term infection were recorded.
    CONCLUSIONS: PEEK PSIs offer significant advantages in craniofacial reconstructions. Despite challenges in predicting soft tissue adaptation, overall patient satisfaction was high with no long-term complications. Future improvements should focus on predicting and enhancing soft tissue adaptations.
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  • 文章类型: Case Reports
    当考虑反向肩关节置换术(RSA)时,假体不稳定是最有挑战性的并发症之一。其他工具可用于提高关节置换术计划和执行的准确性,例如基于计算机断层扫描(CT)扫描和术中导航的三维(3D)虚拟规划。我们报告了一例84岁的男性,因RSA假体不稳定合并严重的关节盂畸形和骨丢失而接受治疗,和亚临床假体周围关节感染(PJI)。最终的手术包括根据3D-CT扫描中检测到的骨缺损植入定制的metaglene组件,并在计算机辅助的术中导航的帮助下植入。患者定期随访一年,并进行临床和放射学评估,没有进一步的假体脱位或PJI。良好的总体满意度,令人满意的运动范围,和可接受的功能评分(美国肩肘外科医师评分62,Constant-Murley评分36)。这是第一个描述,根据我们的知识,在术中导航的帮助下植入定制的关节盂基板。结合使用3D-CT计划和术中计算机辅助导航,即使存在大量骨缺损,也可以管理复杂的假体翻修手术病例。
    Prosthetic instability is one of the most challenging complications to manage when considering reverse shoulder arthroplasty (RSA). Additional tools are available to improve accuracy in planning and execution of arthroplasties, such as 3-dimensional (3D) virtual planning based on computer tomography (CT) scan and intra-operative navigation. We report a case of an 84-year-old male treated for RSA prosthetic instability combined with severe glenoid deformity and bone loss, and subclinical periprosthetic joint infection (PJI). The definitive surgery consisted in implanting a customized metaglene component realized on the basis of the bone defect detected in the 3D-CT scan and implanted with the aid of computer-assisted intra-operative navigation. The patient was periodically followed-up for a year with clinical and radiological evaluations with the absence of further prosthetic dislocations nor PJI, a good overall satisfaction, a satisfying range of motion, and acceptable functional scores (American Shoulder and Elbow Surgeons Score 62, Constant-Murley Score 36). This is the first description, to our knowledge, of a customized glenoid baseplate implanted with the aid of intraoperative navigation. The combined use of 3D-CT planning and intra-operative computer-assisted navigation allows to manage complex cases of prosthetic revision surgery even where extensive bone defects are present.
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  • 文章类型: Journal Article
    全髋关节置换术(THA)通常使用现成的植入物进行。在股骨近端的解剖结构和杆的几何形状之间严重不匹配的情况下,使用定制的茎可能变得必要。这项研究的目的是调查一个制造商定制的茎的植入精度(CTX茎,AQ植入物)并确定错位的风险因素。回顾性招募了2014年至2020年在六个高容量学术中心接受定制CTX干细胞的所有患者。阀杆的位置,根据词干版本确定,茎冠状角,和射线照片上的植入深度,与计划相比。研究了射线照相和人口统计学参数对位置的影响。结果表明,所达到的植入物位置与术前计划有关。虽然茎冠状角与预期位置仅略有不同,茎型和植入深度显示出很高的频率和偏差量。右茎显示出明显高于计划的位置。外科医生在植入定制的茎时必须意识到这个潜在的问题。
    Total hip arthroplasty (THA) is commonly performed using off-the-shelf implants. In the case of a severe mismatch between the anatomy of the proximal femur and the geometry of the stem, the use of custom-made stems might become necessary. The goal of this study was to investigate the precision of the implantation of custom-made stems of one manufacturer (CTX stem, AQ Implants) and to determine risk factors for malpositioning. All patients receiving a custom-made CTX stem between 2014 and 2020 at six high-volume academic centers were retrospectively recruited. The achieved position of the stem, as determined by stem version, stem coronal angle, and implantation depth on radiographs, was compared to the plan. The influence of radiographic and demographic parameters on the position was investigated. The results revealed a high variability of the achieved implant position in relation to the preoperative plan. While the stem coronal angle only differed slightly from the intended position, the stem version and the implantation depth showed a high frequency and amount of deviation. Right stems showed significantly higher positions than planned. Surgeons must be aware of this potential problem when implanting custom-made stems.
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  • 文章类型: Journal Article
    反向全肩关节置换术有时在解决大量骨质流失方面具有挑战性,在主要或修订设置中。定制组件最近已进入肩部假体,旨在在广泛的关节盂骨破坏的情况下提供帮助。由于严格的适应症和这些植入物的最近引入,定制的关节盂植入物的使用还不是很普遍。然而,早期的结果是有希望的。这篇综述的目的是总结和分析现有的文献。因此,根据PRISMA指南进行系统评价.全面搜索PubMed数据库,科克伦,和Livivo用于筛选有关定制关节盂植入物的临床和放射学结果的研究报告。该综述包括四项共46个肩膀的研究。患者平均年龄为68.8岁,平均随访时间为24.3个月。加权平均值显示CMS增加(32.7分),在ASES(39.8分),在前倾(67.4度),外展(51.9度)和VAS下降(5.4分)。因此,定制的关节盂植入物是一个可行的选择,在大的关节盂骨丢失的情况下,在初次和翻修肩关节置换术中。
    Reverse total shoulder arthroplasty presents itself sometimes as challenging when it comes to addressing massive bone loss, either in primary or revision settings. Custom components recently have made their way into shoulder prosthetics and are meant to help in the case of extensive glenoid bone destruction. Because of strict indication and the fairly recent introduction of these implants, the usage of custom-made glenoid implants is not very common yet. However, the early results are promising. The purpose of this review was to summarize and analyze the available literature. Therefore, a systematic review was performed according to PRISMA guidelines. A comprehensive search of the databases PubMed, Cochrane, and Livivo was performed to screen for studies reporting on clinical and radiological outcomes of custom glenoid implants. Four studies with a total of 46 shoulders were included in this review. The mean patient age was 68.8 years and the mean time of follow-up was 24.3 months. The weighted means showed an increase in CMS (32.7 points), in ASES (39.8 points), in anteversion (67.4 degrees), and in abduction (51.9 degrees) and a decrease in VAS (5.4 points). Custom-made glenoid implants are therefore a viable option in cases of large combined glenoid bone loss, both in primary and revision shoulder arthroplasty.
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  • 文章类型: Journal Article
    目的:这项研究的目的是检查定制的部分骨盆置换(PPRs)在翻修全髋关节置换术(rTHA)中的植入准确性。定制的植入物提供了在严重髋臼骨丢失的情况下实现重建的选择。通过分析CT和X线片成像中的植入物偏差以及相关的早期临床并发症,我们的目标是优化定制植入物的使用。
    方法:分析了rTHA中PoproskyIII缺损的连续45个(2014年至2019年)PPR系列,比较了用于制造植入物的术前计划CT扫描与术后CT扫描和X光片。前倾(AV),倾斜度(IC),与术前计划植入位置的偏差,并探索了旋转中心(COR)的偏差。记录术后早期并发症,并寻找错位的因素。平均随访30个月(SD19;6至74),有四名患者失去随访。
    结果:计划和达到的AV和IC之间的平均CT定义差异(Δ)为4.5°(SD3°;0°至12°)和4°(SD3.5°;1°至12°),分别。错位(Δ>10°)发生在五个臀部(10.6%)。42例(93%)计划进行原生COR重建,平均3D偏差向量为15.5mm(SD8.5;4至35)。发现股骨柄固位错位没有显著影响,手术方法,或固定方法。
    结论:在短期随访中,我们发现PPR为髋臼骨大量丢失的rTHA提供了可行的解决方案,由于可以通过精心的计划来完成高度精确的定位,实现解剖重建。所达到的位置的准确性有助于减少并发症,而螺钉固定不会对重要结构造成伤害。引用本文:骨关节J2022;104-B(10):1110-1117。
    OBJECTIVE: The aim of this study was to examine the implant accuracy of custom-made partial pelvis replacements (PPRs) in revision total hip arthroplasty (rTHA). Custom-made implants offer an option to achieve a reconstruction in cases with severe acetabular bone loss. By analyzing implant deviation in CT and radiograph imaging and correlating early clinical complications, we aimed to optimize the usage of custom-made implants.
    METHODS: A consecutive series of 45 (2014 to 2019) PPRs for Paprosky III defects at rTHA were analyzed comparing the preoperative planning CT scans used to manufacture the implants with postoperative CT scans and radiographs. The anteversion (AV), inclination (IC), deviation from the preoperatively planned implant position, and deviation of the centre of rotation (COR) were explored. Early postoperative complications were recorded, and factors for malpositioning were sought. The mean follow-up was 30 months (SD 19; 6 to 74), with four patients lost to follow-up.
    RESULTS: Mean CT defined discrepancy (Δ) between planned and achieved AV and IC was 4.5° (SD 3°; 0° to 12°) and 4° (SD 3.5°; 1° to 12°), respectively. Malpositioning (Δ > 10°) occurred in five hips (10.6%). Native COR reconstruction was planned in 42 cases (93%), and the mean 3D deviation vector was 15.5 mm (SD 8.5; 4 to 35). There was no significant influence in malpositioning found for femoral stem retention, surgical approach, or fixation method.
    CONCLUSIONS: At short-term follow-up, we found that PPR offers a viable solution for rTHA in cases with massive acetabular bone loss, as highly accurate positioning can be accomplished with meticulous planning, achieving anatomical reconstruction. Accuracy of achieved placement contributed to reduced complications with no injury to vital structures by screw fixation.Cite this article: Bone Joint J 2022;104-B(10):1110-1117.
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  • 文章类型: Journal Article
    在脊柱手术中,3D假体代表了在切除需要“整体”切除的脊柱肿瘤后进行脊柱重建的有用工具。这是一个复杂而苛刻的程序,旨在恢复脊柱长度,对齐和承重能力,并提供即时的稳定性。因此,在这篇系统综述中,作者检索了文献,以调查和讨论使用3D打印定制椎体治疗脊柱肿瘤的优势和局限性.根据PRISMA(系统审查和荟萃分析的首选报告项目)声明进行了系统的文献综述,在发布日期方面没有限制。将收集的研究结果输出到Mendeley。根据以下纳入标准选择文章:完整文章的可用性,完整的英文文章,关于在全部或部分椎体切除后植入3D定制假体的研究,关于经组织学证实诊断为原发性脊柱肿瘤或孤立骨转移的患者的研究;评估3d定制假体在宫颈中的植入的研究,胸廓,和腰椎。本文献综述包括19项已发表的研究,总共包括87名患者,男性49人(56.3%),女性38人(43.7%)。评估主要肿瘤位置和原发肿瘤诊断。3D定制假体代表了脊柱重建中肿瘤整块切除后的可行工具。这个程序仍在发展,和长期随访是强制性的,以评估其安全性和有用性。
    In spinal surgery, 3D prothesis represents a useful instrument for spinal reconstruction after the removal of spinal tumors that require an \"en bloc\" resection. This represents a complex and demanding procedure, aiming to restore spinal length, alignment and weight-bearing capacity and to provide immediate stability. Thus, in this systematic review the authors searched the literature to investigate and discuss the advantages and limitations of using 3D-printed custom-made vertebral bodies in the treatment of spinal tumors. A systematic literature review was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement, with no limits in terms of date of publication. The collected studies were exported to Mendeley. The articles were selected according to the following inclusion criteria: availability of full articles, full articles in English, studies regarding the implant of 3D custom-made prothesis after total or partial vertebral resection, studies regarding patients with a histologically confirmed diagnosis of primary spinal tumor or solitary bone metastasis; studies evaluating the implant of 3d custom-made prothesis in the cervical, thoracic, and lumbar spine. Nineteen published studies were included in this literature review, and include a total of 87 patients, 49 males (56.3%) and 38 females (43.7%). The main tumoral location and primary tumor diagnosis were evaluated. The 3D custom-made prothesis represents a feasible tool after tumor en-bloc resection in spinal reconstruction. This procedure is still evolving, and long-term follow-ups are mandatory to assess its safeness and usefulness.
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  • 文章类型: Journal Article
    作为一项有前途的制造技术,3D打印技术广泛应用于医疗领域。在骨关节缺损的治疗中,3D打印技术的出现为功能性关节面的重建提供了新的选择。目前,3D打印技术已被用于模型等临床应用,患者专用仪器(PSIs),和定制的植入物来治疗创伤引起的关节缺损,运动损伤,和肿瘤。本文综述了3D打印技术在骨关节缺损治疗中的应用现状,并讨论了其优势,缺点,以及未来可能的研究策略。
    As a promising manufacturing technology, three-dimensional (3D) printing technology is widely used in the medical field. In the treatment of osteoarticular defects, the emergence of 3D printing technology provides a new option for the reconstruction of functional articular surfaces. At present, 3D printing technology has been used in clinical applications such as models, patient-specific instruments (PSIs), and customized implants to treat joint defects caused by trauma, sports injury, and tumors. This review summarizes the application status of 3D printing technology in the treatment of osteoarticular defects and discusses its advantages, disadvantages, and possible future research strategies.
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  • 文章类型: Journal Article
    目的:为了治疗膝关节骨性关节炎(OA),可以使用定制的交叉保留全膝关节置换术(CCR-TKA)系统,包括个性化的仪器和植入物。这项单中心队列研究的目的是分析植入第二代定制植入物的一系列患者的患者报告和功能结果。
    方法:在我们的关节成形术中心,我们前瞻性招募了一组接受全膝关节置换(TKA)治疗的三房性关节炎患者,这些患者采用定制的交叉保留(CCR)植入物设计.患者的纳入标准包括存在完整的后交叉韧带和副韧带,以及仅限于<15°内翻的膝关节畸形。外翻,或屈曲挛缩。评估患者的运动范围(ROM),膝关节社会评分(KSS),西安大略省和麦克马斯特大学骨关节炎指数(WOMAC),和简短形式(SF)-12的身体和心理分数,术前,在3个月和6个月时,以及术后1、2、3和5年的随访(FU)。
    结果:患者的平均年龄为64岁(范围:40-81),平均BMI为31(范围:23-42),总的来说,包括28名女性和45名男性患者。平均随访2.5年,植入物存活率为97.5%(一次败血症松动)。KSS膝关节和功能评分明显改善(p<0.001),分别,术前访视的41和53,分别为92和86,在术后5年的时间点。在5年FU时,SF-12的身体和心理评分显着(p<0.001)从术前的28和50提高到50和53,分别。患者的膝关节整体活动范围有了显着改善,从术前就诊的106°到122°,平均而言,术后5年。在5年FU时,WOMAC总分从术前的49.1显著(p<0.001)提高到术后的11.4。
    结论:尽管本研究中没有与其他植入物进行比较,患者在手术后的第一年内报告了较高的总体满意度和功能结局的改善,这种情况在接下来的几年里一直持续着。这些中期结果与当前文献中报道的结果相比是极好的。需要使用该设备进行长期比较研究。证据水平3b(个别病例对照研究)。
    OBJECTIVE: To treat patients with tricompartimental knee osteoarthritis (OA), a customized cruciate-retaining total knee arthroplasty (CCR-TKA) system can be used, including both individualized instrumentation and implants. The objective of this monocentric cohort study was to analyze patient-reported and functional outcomes in a series of patients implanted with the second generation of this customized implant.
    METHODS: At our arthroplasty center, we prospectively recruited a cohort of patients with tricompartmental gonarthrosis to be treated with total knee replacement (TKA) using a customized cruciate-retaining (CCR) implant design. Inclusion criteria for patients comprised the presence of intact posterior cruciate and collateral ligaments and a knee deformity that was restricted to <15° varus, valgus, or flexion contracture. Patients were assessed for their range of motion (ROM), Knee Society Score (KSS), Western Ontario and McMaster University osteoarthritis index (WOMAC), and short form (SF)-12 physical and mental scores, preoperatively, at 3 and 6 months, as well as at 1, 2, 3, and 5 years of follow-up (FU) postoperatively.
    RESULTS: The average age of the patient population was 64 years (range: 40-81), the average BMI was 31 (range: 23-42), and in total, 28 female and 45 male patients were included. Implant survivorship was 97.5% (one septic loosening) at an average follow-up of 2.5 years. The KSS knee and function scores improved significantly (p < 0.001) from, respectively, 41 and 53 at the pre-operative visit, to 92 and 86, respectively, at the 5-year post-operative time point. The SF-12 Physical and Mental scores significantly (p < 0.001) improved from the pre-operative values of 28 and 50, to 50 and 53 at the 5-year FU, respectively. Patients experienced significant improvements in their overall knee range of motion, from 106° at the preoperative visit to 122°, on average, 5 years postoperatively. The total WOMAC score significantly (p < 0.001) improved from 49.1 preoperatively to 11.4 postoperatively at 5-year FU.
    CONCLUSIONS: Although there was no comparison to other implants within this study, patients reported high overall satisfaction and improvement in functional outcomes within the first year from surgery, which continued over the following years. These mid-term results are excellent compared with those reported in the current literature. Comparative long-term studies with this device are needed. Level of evidence 3b (individual case-control study).
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  • 文章类型: Case Reports
    一名2岁的马耳他人的骨盆四肢步态不稳。根据影像学检查,在T5-T8诊断为先天性畸形和在T6-T7诊断为严重后凸畸形导致脊髓压迫。对T6和T7椎体进行背侧椎板切除和稳定。由于椎骨的尺寸很小,并且严重变形,新型定制钛植入物用于脊柱稳定。手术后2周临床症状得到缓解。尽管手术后373天的影像学检查显示植入物轻微松动,术后病程保持平稳。该报告描述了在狗的脊柱固定手术中使用新型定制的钛植入物。
    A 2-year-old Maltese was presented with wobbly gait of the pelvic limbs. Based on imaging examinations, a diagnosis of congenital malformation at T5-T8 and severe kyphosis causing spinal cord compression at T6-T7 was made. Dorsal laminectomy and stabilization of T6 and T7 vertebrae were performed. As the size of the vertebrae was small and they were severely deformed, novel custom-made titanium implants were used for spinal stabilization. Clinical signs were resolved 2 weeks after surgery. Although radiographic examination 373 days after surgery showed slight loosening of implants, post-operative course remained uneventful. This report describes the use of novel custom-made titanium implants for spinal fixation surgery in a dog.
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  • 文章类型: Journal Article
    BACKGROUND: Severe acetabular bone loss in revision total hip arthroplasty (RTHA), both with or without pelvic discontinuity, remains a great challenge in orthopaedic surgery.
    OBJECTIVE: The aim of this study was to evaluate risk factors for failure of custom-made acetabular implants in RTHA.
    METHODS: Seventy patients with severe acetabular bone loss (Paprosky Type III) and pelvic discontinuity, who required RTHA, were included in our study. All prostheses were constructed based on a thin-layer computed-tomography (CT) scan of the pelvis. The treatment was considered unsuccessful in the event of periprosthetic joint infection (PJI) or aseptic loosening (AL) with need for explantation of the custom-made acetabular implant.
    RESULTS: The average follow-up was 41.9 ± 34.8 months (range 1.5-120). Implant survival at last follow-up was 75.7% (53 of 70). Explantation was necessary in 17 cases (15 PJI; 2 AL). Previous PJI as reason for RTHA (p= 0.025; OR 3.56 (95% CI: 1.14; 11.21)), additional revision of femoral components (p= 0.003; OR 8.4 (95% CI: 1.75; 40.42)), rheumatoid disease (p= 0.039; OR 3.43 (95% CI: 1.01; 11.40)), elevated preoperative CRP > 15.2 mg/l (p= 0.015; AUC: 0.7) and preoperative haemoglobin < 10.05 (p= 0.022; AUC: 0.69) were statistically significant risk factors associated with treatment failure. Age and BMI were not statistically significant contributing to implant failure.
    CONCLUSIONS: Risk factors for treatment failure were a previous PJI, additional revision of femoral component, rheumatoid disease, elevated preoperative CRP and low preoperative haemoglobin. Awareness of these risk factors will help to improve future treatment standards.
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