金属3D打印个性化髋臼翼状接骨板的研发及实验研究

发布时间：2018-12-14 00:01

【摘要】：研究背景骨盆、髋臼解剖结构复杂,对于累及四边体的复杂髋臼骨折,传统手术入路及内固定难以满足复位、固定要求,采用个性化接骨板治疗复杂髋臼骨折尚处于空白。研究目的针对复杂髋臼骨折患者设计个性化髋臼翼状接骨板,使用金属3D打印技术(SLM)制造,对该设计方法和制造方式进行可行性及安全性验证,经验证成功后将其应用于临床,对患者进行随访研究,评价其优势及早期临床治疗疗效。研究方法对某一复杂髋臼骨折患者骨盆数字化三维重建,对骨折进行模拟复位、置钉,利用镜像原理及逆向工程技术,设计完全解剖型的个性化翼状接骨板,并进行个性化精准置钉设计,采用金属3D打印技术制造,对其进行后加工处理,得到产品。对5具尸体标本采用上述方法设计并制造10块个性化接骨板,采用单一腹直肌外侧入路将其植入到标本中,验证使用该入路植入接骨板的可行性,测量接骨板与贴合骨面的距离,验证其贴合性;对12名复杂髋臼骨折患者采用上述方法设计并制造12块个性化接骨板,将其植入到3D打印骨盆模型中,验证螺钉孔设计的安全性。回顾性分析2016年3月～2016年7月,采用经腹直肌外侧入路显露、复位,使用3D打印技术辅助模拟复位,结合个性化设计、金属3D打印髋臼翼形接骨板固定治疗8例复杂髋臼骨折的临床资料:其中男性4例,女性4例;年龄31-76岁,平均57岁:髋臼骨折按Letournel-Judet分型:前方伴后半横2例,双柱骨折6例,均无涉及髋臼后壁骨折及对侧半骨盆骨折。手术在插管全麻下平卧位进行,经前方腹直肌外侧切口入路,直视下对髋臼前、后柱骨折进行复位,将个性化设计定制的钢板放置于髋臼的内侧面,检查钢板与骨面的贴合程度,再按术前设定的螺钉位置、方向、长度置入螺钉,C形臂X光机透视后,检查骨折复位、固定情况。结果采用上述方法成功设计并制造出个性化髋臼翼状接骨板,接骨板与尸体标本骨面平均距离在1mm左右,与3D打印骨盆模型表面平均距离在0.7mm左右,接骨板上所有螺钉均未穿入髋臼窝。本组8例均顺利完成手术。术后X线及CT显示髋臼前后柱骨折复位固定良好,个性化翼状接骨板与骨面完全贴合,无围手术期并发症发生,按照Matta影像学复位评估标准:优3例,良4例,一般1例,总体优良率87.5%;随访9～12个月,骨折均愈合;根据改良的Merled' Aubigne和Postel评分系统,髋关节功能:优5例,良2例,可1例,总优良率87.5%。结论应用镜像原理和逆向工程原理设计的个性化接骨板贴合度高,螺孔设计安全有效;经腹直肌外侧切口入路结合个性化设计、私人定制、金属3D打印髋臼翼形钢板治疗复杂髋臼骨折,能对复杂髋臼柱骨折解剖复位,并达到坚强的固定,真正实现复杂髋臼骨折的精准化、个性化、微创化。
[Abstract]:Background pelvic and acetabular anatomical structures are complex. Traditional surgical approaches and internal fixation are difficult to meet the requirements of reduction and fixation for complex acetabular fractures involving tetrahedral bodies. The treatment of complex acetabular fractures with individualized plates is still blank. Objective to design a personalized acetabular winglike plate for patients with complex acetabular fractures, and to verify the feasibility and safety of the design method and manufacturing method by using metal 3D printing technology (SLM). The patients were followed up to evaluate their advantages and early therapeutic effects. Methods A complex acetabular fracture was reconstructed by digital three-dimensional reconstruction of the pelvis. The fracture was reduced and nailed. A completely anatomical individualized winglike plate was designed by using mirror image principle and reverse engineering technique. The design of individualized precision nail was carried out, and the metal 3D printing technology was used to make it, which was processed after processing, and the product was obtained. Ten individualized plates were designed and manufactured for 5 cadavers, and were implanted into the specimens by a single lateral approach of rectus abdominis to verify the feasibility of using this approach to implant the plates. The distance between the plate and the bony surface was measured to verify its compatibility. Twelve individualized plates were designed and fabricated in 12 patients with complex acetabular fractures and implanted into 3D printed pelvic models to verify the safety of screw hole design. From March 2016 to July 2016, we used lateral approach of rectus abdominis to expose and reposition, and 3D printing technology was used to assist simulation reduction, combined with individualized design. Clinical data of 8 cases of complex acetabular fractures treated with metal 3D printed acetabular wing plate fixation: male 4 cases female 4 cases; The average age was 57 years (31-76 years). According to Letournel-Judet classification, there were 2 cases with anterior posterior half transverse fracture and 6 cases with double column fracture, none of which involved posterior acetabular wall fracture or contralateral hemipelvic fracture. The operation was performed in the supine position under general anesthesia. The anterior rectus abdominis lateral incision approach was adopted. The anterior and posterior column fractures were reduced under direct vision. The customized plate was placed on the inner side of the acetabular. According to the position, direction and length of the screws set before the operation, the screws were inserted into the plates. After the C-arm X-ray machine fluoroscopy, fracture reduction and fixation were examined. Results the individual acetabular winglike plate was successfully designed and manufactured by using the above method. The average distance between the plate and the bone surface of the cadaveric specimen was about 1mm, and the average distance between the plate and the 3D printed pelvis model surface was about 0.7mm. All screws on the plate were not penetrated into the acetabular fossa. The operation was successfully completed in 8 cases. X-ray and CT showed that the acetabular anterior and posterior column fractures were well reduced and fixed, the individualized winglike plates were completely fitted to the bone surface, and there were no perioperative complications. According to the Matta imaging evaluation criteria: excellent in 3 cases, good in 4 cases, average in 1 case. The overall excellent and good rate was 87.5%; According to the improved Merled' Aubigne and Postel scoring system, the hip joint function was excellent in 5 cases, good in 2 cases, fair in 1 case, and the total excellent and good rate was 87.5%. Conclusion the application of mirror image principle and reverse engineering principle in the design of individualized bone-plate has a high degree of adhesion and the design of screw holes is safe and effective. The external incision of rectus abdominis combined with individualized design, personal customization, metal 3D printed acetabular wing plate for the treatment of complex acetabular fractures, can be anatomical reduction of complex acetabular column fractures, and achieve strong fixation. The complex acetabular fracture is truly accurate, individualized and minimally invasive.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R687.3

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