Jan Paul Frölke, Robin Atallah, Ruud Leijendekkers
{"title":"加压式骨锚定假体在短段经股截肢患者中的应用。","authors":"Jan Paul Frölke, Robin Atallah, Ruud Leijendekkers","doi":"10.2106/JBJS.ST.23.00007","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This video article describes the use of a bone-anchored prosthesis in patients with high above-the-knee amputations resulting in short residual limbs, most typically from trauma, cancer, infections, or dysvascular disease. The use of a socket prosthesis is usually unsuccessful in patients with a high transfemoral amputation because such prostheses have an unstable connection and often require additional waist belts for better attachment to the short residual limb. In most cases, a bone-anchored prosthesis results in substantial improvements in wear time, mobility, and quality of life in these patients. These patients may also be excellent candidates for early osseointegration implant surgery, given the knowledge that socket prostheses are rarely successful.</p><p><strong>Description: </strong>This procedure is preferably performed in a single stage. After the surgical procedure, most patients stay 1 or 2 nights in the hospital, depending on the magnitude of the surgery (e.g., bilateral implantation of an osseointegration implant) and their comorbidities. Procedure steps include (1) preoperative implant planning, (2) patient positioning and setup, (3) soft-tissue correction (optional) and exposure of residual bone, (4) revision osteotomy with guided shortening, (5) preparation of the medullary canal and perpendicular cutoff plane, (6) marking of the lag screw with a custom-made aiming device and dummy prosthesis, (7) insertion of the intramedullary component with optional bone augmentation, (8) insertion of the lag screw, (9) soft-tissue contouring and closure, and (10) stoma creation and dual cone assembly.</p><p><strong>Alternatives: </strong>Simultaneous major leg amputation and implantation of an osseointegration prosthesis is not advocated as treatment. First, a rehabilitation program with a socket-suspended prosthesis should be trialed before a patient can apply for a bone-anchored prosthesis. After rehabilitation, satisfaction with a socket prosthesis may be adequate, making a bone-anchored prosthesis unnecessary; however, patients with very short residual limbs and/or irregular soft-tissue conditions may be candidates for early implantation of a bone-anchored prosthesis. Contraindications for osseointegration implant surgery are severe diabetes (with complications), severe bone deformity, immature bone, bone diseases (chronic infection or metastasis), current chemotherapy, severe vascular diseases, pain without a clear cause, body mass index of >30 kg/m<sup>2</sup>, and smoking.</p><p><strong>Rationale: </strong>About half of patients with a major lower-limb amputation who use an artificial leg are able to function acceptably well with use of a socket-suspended prosthesis; however, in cases with a high transfemoral amputation level, severe limitations may be expected, resulting in reduced prosthesis use, mobility, and quality of life. In these cases, energy transfer from limb to prosthesis is poor because of the so-called pseudojoint, which is the soft-tissue interface, and gross mechanical malalignment is common. These issues lead to complications related to skin irritation and poor socket fit, resulting in decreased overall satisfaction and confidence in mobility. An osseointegration implant creates a direct skeletal connection between the residual limb and artificial leg, in which energy transfer is optimal and mechanical alignment is radically improved.</p><p><strong>Expected outcomes: </strong>We performed a prospective study with a 1-year follow-up<sup>1</sup>. A total of 16 patients with a short residual limb following transfemoral amputation received a gamma-type osseointegration implant with additional lag screw fixation toward the femoral neck. Most patients were male, had a traumatic amputation, and underwent a 2-stage surgery. Prosthesis wear time and patient health-related quality of life were measured with use of the Questionnaire for Persons with a Transfemoral Amputation (QTFA) prosthetic use score and global score, respectively. Both measures improved significantly from baseline to 1-year follow-up. The global score is not applicable for patients who do not use a prosthesis. For the 8 patients (i.e., 50% of the cohort) who did not use a prosthesis at baseline, the third question of the global score (G3 Q3) was utilized instead. This question asks, \"How would you summarize your overall situation as an amputee?\" As measured with this question, these patients also showed a substantial improvement in quality of life from baseline to 1-year follow-up. Adverse events that can occur following this surgical procedure include infection of the soft tissues and/or bone, periprosthetic fracture, implant breakage, aseptic loosening, and redundancy of soft tissues. In our study, only soft-tissue infections occurred. All superficial soft-tissue infections were successfully treated with use of oral antibiotics. One patient with a deep soft-tissue infection required surgery for abscess drainage. One patient required additional surgery to correct redundancy of soft tissues. Dual-cone adaptor breakage occurred twice; both cases were successfully treated in an outpatient clinic setting. We concluded that the short-term results of this treatment were acceptable. Mid-term follow-up results are currently being collected.</p><p><strong>Important tips: </strong>Preoperative implant planning should be guided by surgical instructions with a custom-made implant design, with the aim of performing the procedure in a single stage.The use of a traction table may be beneficialLiberally resect soft-tissue redundancy.Utilize water-cooled power sawing.Utilize fluoroscopy to guide drilling.The use of radiographic markers can help guide exact lag screw positioning.In case of little resistance during insertion of the intramedullary component, utilize bone morphogenetic protein-2 (BMP-2; Inductos), bone struts, and/or bone-impaction graftingUtilize a lag screw to increase stabilityDo not close muscle fascia over the implant.Perform a 2-stage procedure only in cases with bone reconstructions, with the stages undertaken at a 10 to 12-week interval.Perform regular postoperative assessment according to your institutional follow-up schedule.</p><p><strong>Acronyms and abbreviations: </strong>BAP = bone-anchored prosthesisOI = osseointegration implantOFI-Y = custom-made press-fit titanium bone-anchored femur implant (BADAL X; OTN Implants)FL = femur lengthOFI-C = standard press-fit titanium bone-anchored implant (BADAL-X; OTN Implants)CT = computed tomographyDCA = dual-cone adapterK-wire = Kirschner wire.</p>","PeriodicalId":44676,"journal":{"name":"JBJS Essential Surgical Techniques","volume":"15 1","pages":""},"PeriodicalIF":1.0000,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11841842/pdf/","citationCount":"0","resultStr":"{\"title\":\"Press-Fit Bone-Anchored Prosthesis for Patients with Short Transfemoral Amputation.\",\"authors\":\"Jan Paul Frölke, Robin Atallah, Ruud Leijendekkers\",\"doi\":\"10.2106/JBJS.ST.23.00007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This video article describes the use of a bone-anchored prosthesis in patients with high above-the-knee amputations resulting in short residual limbs, most typically from trauma, cancer, infections, or dysvascular disease. The use of a socket prosthesis is usually unsuccessful in patients with a high transfemoral amputation because such prostheses have an unstable connection and often require additional waist belts for better attachment to the short residual limb. In most cases, a bone-anchored prosthesis results in substantial improvements in wear time, mobility, and quality of life in these patients. These patients may also be excellent candidates for early osseointegration implant surgery, given the knowledge that socket prostheses are rarely successful.</p><p><strong>Description: </strong>This procedure is preferably performed in a single stage. After the surgical procedure, most patients stay 1 or 2 nights in the hospital, depending on the magnitude of the surgery (e.g., bilateral implantation of an osseointegration implant) and their comorbidities. Procedure steps include (1) preoperative implant planning, (2) patient positioning and setup, (3) soft-tissue correction (optional) and exposure of residual bone, (4) revision osteotomy with guided shortening, (5) preparation of the medullary canal and perpendicular cutoff plane, (6) marking of the lag screw with a custom-made aiming device and dummy prosthesis, (7) insertion of the intramedullary component with optional bone augmentation, (8) insertion of the lag screw, (9) soft-tissue contouring and closure, and (10) stoma creation and dual cone assembly.</p><p><strong>Alternatives: </strong>Simultaneous major leg amputation and implantation of an osseointegration prosthesis is not advocated as treatment. First, a rehabilitation program with a socket-suspended prosthesis should be trialed before a patient can apply for a bone-anchored prosthesis. After rehabilitation, satisfaction with a socket prosthesis may be adequate, making a bone-anchored prosthesis unnecessary; however, patients with very short residual limbs and/or irregular soft-tissue conditions may be candidates for early implantation of a bone-anchored prosthesis. Contraindications for osseointegration implant surgery are severe diabetes (with complications), severe bone deformity, immature bone, bone diseases (chronic infection or metastasis), current chemotherapy, severe vascular diseases, pain without a clear cause, body mass index of >30 kg/m<sup>2</sup>, and smoking.</p><p><strong>Rationale: </strong>About half of patients with a major lower-limb amputation who use an artificial leg are able to function acceptably well with use of a socket-suspended prosthesis; however, in cases with a high transfemoral amputation level, severe limitations may be expected, resulting in reduced prosthesis use, mobility, and quality of life. In these cases, energy transfer from limb to prosthesis is poor because of the so-called pseudojoint, which is the soft-tissue interface, and gross mechanical malalignment is common. These issues lead to complications related to skin irritation and poor socket fit, resulting in decreased overall satisfaction and confidence in mobility. An osseointegration implant creates a direct skeletal connection between the residual limb and artificial leg, in which energy transfer is optimal and mechanical alignment is radically improved.</p><p><strong>Expected outcomes: </strong>We performed a prospective study with a 1-year follow-up<sup>1</sup>. A total of 16 patients with a short residual limb following transfemoral amputation received a gamma-type osseointegration implant with additional lag screw fixation toward the femoral neck. Most patients were male, had a traumatic amputation, and underwent a 2-stage surgery. Prosthesis wear time and patient health-related quality of life were measured with use of the Questionnaire for Persons with a Transfemoral Amputation (QTFA) prosthetic use score and global score, respectively. Both measures improved significantly from baseline to 1-year follow-up. The global score is not applicable for patients who do not use a prosthesis. For the 8 patients (i.e., 50% of the cohort) who did not use a prosthesis at baseline, the third question of the global score (G3 Q3) was utilized instead. This question asks, \\\"How would you summarize your overall situation as an amputee?\\\" As measured with this question, these patients also showed a substantial improvement in quality of life from baseline to 1-year follow-up. Adverse events that can occur following this surgical procedure include infection of the soft tissues and/or bone, periprosthetic fracture, implant breakage, aseptic loosening, and redundancy of soft tissues. 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引用次数: 0
摘要
背景:这篇视频文章描述了骨锚定假体在膝上高位截肢导致残肢短的患者中的应用,这些患者通常是由于创伤、癌症、感染或血管异常疾病。在高位经股截肢患者中,使用窝形假体通常是不成功的,因为这种假体连接不稳定,通常需要额外的腰带来更好地附着在短的残肢上。在大多数情况下,骨锚定假体可以显著改善这些患者的佩戴时间、活动能力和生活质量。这些患者也可能是早期骨整合种植手术的优秀候选人,因为我们知道,窝骨假体很少成功。说明:该过程最好在单阶段进行。手术后,根据手术的大小(例如,双侧骨整合种植体的植入)及其合并症,大多数患者在医院住1或2个晚上。操作步骤包括(1)术前种植体计划,(2)患者定位和设置,(3)软组织矫正(可选)和残余骨暴露,(4)引导缩短的翻修截骨术,(5)准备髓管和垂直截骨面,(6)使用定制瞄准装置和假体标记拉力螺钉,(7)可选骨增强器插入髓内组件,(8)插入拉力螺钉,(9)软组织轮廓和闭合,(10)造口和双锥装配。替代方法:不提倡同时截肢并植入骨整合假体作为治疗方法。首先,在病人可以申请骨锚固定假体之前,应该先试验使用套孔悬浮假体的康复计划。康复后,对套孔假体的满意度可能足够,无需骨锚定假体;然而,残肢非常短和/或软组织状况不规则的患者可能是早期植入骨锚定假体的候选者。严重糖尿病(伴并发症)、严重骨畸形、骨不成熟、骨疾病(慢性感染或转移)、正在化疗、严重血管疾病、不明原因疼痛、体重指数> ~ 30kg /m2、吸烟等为骨整合种植体手术禁忌症。基本原理:大约一半的下肢截肢患者使用人工腿后,使用支架悬置假体功能良好;然而,在经股截肢高度的病例中,可能会出现严重的限制,导致假体的使用、活动能力和生活质量降低。在这些情况下,由于所谓的假关节是软组织界面,从肢体到假体的能量传递很差,并且普遍存在严重的机械错位。这些问题会导致与皮肤刺激和眼窝不合适相关的并发症,导致整体满意度和对活动的信心下降。骨整合植入物在残肢和假肢之间建立了直接的骨骼连接,其中能量传递是最佳的,机械对齐从根本上得到改善。预期结果:我们进行了一项为期1年的前瞻性研究。共有16例经股骨截肢后残肢短的患者接受了gamma型骨整合种植体,并在股骨颈处附加拉力螺钉固定。大多数患者为男性,创伤性截肢,并进行了两期手术。分别使用经股骨截肢者问卷(QTFA)假体使用评分和总体评分来测量假体佩戴时间和患者健康相关生活质量。从基线到1年随访,两项指标均有显著改善。整体评分不适用于不使用假体的患者。对于基线时未使用假体的8例患者(即队列的50%),则使用全局评分的第三个问题(G3 Q3)代替。这个问题问的是:“作为一个截肢者,你会如何总结你的总体情况?”通过这个问题测量,这些患者从基线到1年随访期间的生活质量也有了实质性的改善。该手术后可能发生的不良事件包括软组织和/或骨骼感染、假体周围骨折、植入物断裂、无菌性松动和软组织冗余。在我们的研究中,只发生了软组织感染。所有浅表软组织感染均经口服抗生素治疗成功。1例深部软组织感染患者需要手术进行脓肿引流。一名患者需要额外的手术来纠正软组织的冗余。 双锥接头断裂两次;两例均在门诊成功治疗。我们的结论是这种治疗的短期效果是可以接受的。目前正在收集中期后续结果。重要提示:术前种植计划应在手术指导下使用定制的种植体设计,目的是在单一阶段完成手术。使用牵引台可能是有益的,可自由切除软组织冗余。采用水冷式动力锯切。利用透视引导钻孔。使用x线照相标记可以帮助精确定位螺钉。如果髓内组件插入过程中阻力很小,则使用骨形态发生蛋白-2 (BMP-2);使用拉力螺钉来增加稳定性。不要关闭种植体上方的筋膜。只有在有骨重建的情况下才需要进行2阶段的手术,每10到12周进行一次。根据你的机构随访计划进行定期的术后评估。缩略语:BAP =骨锚定假体isoi =骨整合植入物tofi - y =定制压合钛骨锚定股骨植入物(BADAL X;FL =股骨长度thofi - c =标准压合钛骨锚定种植体(BADAL-X;CT =计算机断层扫描dca =双锥体适配器克氏针。
Press-Fit Bone-Anchored Prosthesis for Patients with Short Transfemoral Amputation.
Background: This video article describes the use of a bone-anchored prosthesis in patients with high above-the-knee amputations resulting in short residual limbs, most typically from trauma, cancer, infections, or dysvascular disease. The use of a socket prosthesis is usually unsuccessful in patients with a high transfemoral amputation because such prostheses have an unstable connection and often require additional waist belts for better attachment to the short residual limb. In most cases, a bone-anchored prosthesis results in substantial improvements in wear time, mobility, and quality of life in these patients. These patients may also be excellent candidates for early osseointegration implant surgery, given the knowledge that socket prostheses are rarely successful.
Description: This procedure is preferably performed in a single stage. After the surgical procedure, most patients stay 1 or 2 nights in the hospital, depending on the magnitude of the surgery (e.g., bilateral implantation of an osseointegration implant) and their comorbidities. Procedure steps include (1) preoperative implant planning, (2) patient positioning and setup, (3) soft-tissue correction (optional) and exposure of residual bone, (4) revision osteotomy with guided shortening, (5) preparation of the medullary canal and perpendicular cutoff plane, (6) marking of the lag screw with a custom-made aiming device and dummy prosthesis, (7) insertion of the intramedullary component with optional bone augmentation, (8) insertion of the lag screw, (9) soft-tissue contouring and closure, and (10) stoma creation and dual cone assembly.
Alternatives: Simultaneous major leg amputation and implantation of an osseointegration prosthesis is not advocated as treatment. First, a rehabilitation program with a socket-suspended prosthesis should be trialed before a patient can apply for a bone-anchored prosthesis. After rehabilitation, satisfaction with a socket prosthesis may be adequate, making a bone-anchored prosthesis unnecessary; however, patients with very short residual limbs and/or irregular soft-tissue conditions may be candidates for early implantation of a bone-anchored prosthesis. Contraindications for osseointegration implant surgery are severe diabetes (with complications), severe bone deformity, immature bone, bone diseases (chronic infection or metastasis), current chemotherapy, severe vascular diseases, pain without a clear cause, body mass index of >30 kg/m2, and smoking.
Rationale: About half of patients with a major lower-limb amputation who use an artificial leg are able to function acceptably well with use of a socket-suspended prosthesis; however, in cases with a high transfemoral amputation level, severe limitations may be expected, resulting in reduced prosthesis use, mobility, and quality of life. In these cases, energy transfer from limb to prosthesis is poor because of the so-called pseudojoint, which is the soft-tissue interface, and gross mechanical malalignment is common. These issues lead to complications related to skin irritation and poor socket fit, resulting in decreased overall satisfaction and confidence in mobility. An osseointegration implant creates a direct skeletal connection between the residual limb and artificial leg, in which energy transfer is optimal and mechanical alignment is radically improved.
Expected outcomes: We performed a prospective study with a 1-year follow-up1. A total of 16 patients with a short residual limb following transfemoral amputation received a gamma-type osseointegration implant with additional lag screw fixation toward the femoral neck. Most patients were male, had a traumatic amputation, and underwent a 2-stage surgery. Prosthesis wear time and patient health-related quality of life were measured with use of the Questionnaire for Persons with a Transfemoral Amputation (QTFA) prosthetic use score and global score, respectively. Both measures improved significantly from baseline to 1-year follow-up. The global score is not applicable for patients who do not use a prosthesis. For the 8 patients (i.e., 50% of the cohort) who did not use a prosthesis at baseline, the third question of the global score (G3 Q3) was utilized instead. This question asks, "How would you summarize your overall situation as an amputee?" As measured with this question, these patients also showed a substantial improvement in quality of life from baseline to 1-year follow-up. Adverse events that can occur following this surgical procedure include infection of the soft tissues and/or bone, periprosthetic fracture, implant breakage, aseptic loosening, and redundancy of soft tissues. In our study, only soft-tissue infections occurred. All superficial soft-tissue infections were successfully treated with use of oral antibiotics. One patient with a deep soft-tissue infection required surgery for abscess drainage. One patient required additional surgery to correct redundancy of soft tissues. Dual-cone adaptor breakage occurred twice; both cases were successfully treated in an outpatient clinic setting. We concluded that the short-term results of this treatment were acceptable. Mid-term follow-up results are currently being collected.
Important tips: Preoperative implant planning should be guided by surgical instructions with a custom-made implant design, with the aim of performing the procedure in a single stage.The use of a traction table may be beneficialLiberally resect soft-tissue redundancy.Utilize water-cooled power sawing.Utilize fluoroscopy to guide drilling.The use of radiographic markers can help guide exact lag screw positioning.In case of little resistance during insertion of the intramedullary component, utilize bone morphogenetic protein-2 (BMP-2; Inductos), bone struts, and/or bone-impaction graftingUtilize a lag screw to increase stabilityDo not close muscle fascia over the implant.Perform a 2-stage procedure only in cases with bone reconstructions, with the stages undertaken at a 10 to 12-week interval.Perform regular postoperative assessment according to your institutional follow-up schedule.
期刊介绍:
JBJS Essential Surgical Techniques (JBJS EST) is the premier journal describing how to perform orthopaedic surgical procedures, verified by evidence-based outcomes, vetted by peer review, while utilizing online delivery, imagery and video to optimize the educational experience, thereby enhancing patient care.