| Objective:The aim of the study was to explore the more flexible use of 3D printed PEEK prosthesis in repairing bone defects and provide a clinical basis for the most appropriate treatment for patients with different bone defects.Through prospective experimental design,clinical data and image data from patients after prosthesis transplantation were collected and sorted out to evaluate its efficacy and safety by observing and following the patients who received 3D printed customized PEEK prosthesis replacement at different body parts in our hospital before and after operation.Methods:A total of 11 patients(5 males(45.5%)and 6 females(54.5%))who underwent 3D printed PEEK prosthesis implantation from January 2019 to May 2021 in Department of Orthopaedics II,Yunnan Cancer Hospital,the Third Affiliated Hospital of Kunming Medical University were collected.The patients were divided into 6 groups:scapula,clavicle,tibia,fibula,sternum and ulna based on the locations of their lesions.All patients completed their preoperative CT to obtain scanned data and 3D reconstructed images of the target bones.A computer image processing system was used to construct the 3D computer-aided design(CAD)model.3D printing technology was used to generate a 1:1 PEEK prosthesis,after which the placement surgery was performed in strict accordance with the preoperative planning.A rigid brace was used to protect and immobilize the affected area following the surgery for 8 weeks,and could be removed 8 weeks later for low intensity functional training of the surgical area.Real-time preoperative and postoperative data and follow-up data collected 3 months,6 months and annually after operation were recorded.The position of the prosthesis was observed by imaging,the relationship between the prosthesis and normal anatomical tissue and status of prosthesis survival were evaluated;comprehensive evaluation of the efficacy of 3D printed PEEK prosthesis in repairing bone defect was performed following the observation of functional recovery of the repaired and reconstructed structure;the postoperative complications of incision infection and effusion were observed;A monthly review was performed to observe whether there is prosthesis loosening,rejection,fracture.Local and systemic tumor control of patients was also followed.Results:Of the 11 patients,5(5/11,45.5%)were male and 6(6/11,54.5%)were female;the age range was 14 to 52 years,with a mean age of 34.18 years.Nine patients(9/11,81.8%)had lesions in upper limbs and two(2/11,18.2%)in lower limbs.Except for the loss of contact with the patient receiving ulnar prosthesis implantation due to the wrong contact information left,all the other patients obtained a satisfactory length of postoperative follow-up,with an average follow-up time of 9 months(2～16 months).None of the patients had permanent neurological impairment after surgery.Four patients had postoperative effusion in the operation area(4/11,36.4%),of which 2 patients showed that the effusion in the operation area was absorbed more than before during reexamination in the first month after operation,and 2 patients showed that effusion in the operation area began to absorb in the third month after operation.Three patients had postoperative effusion with pneumatosis in the operation area(3/11,27.3%),two patients had effusion and pneumatosis absorption in the operation area at 3 months after operation,and one patient was observed to have absorption of effusion and pneumatosis during reexamination at 6 months after operation.6 patients had postoperative soft tissue swelling,which was significantly improved when reexamined 1 month after operation.One patient had postoperative hypotension(1/11,9.1%),2 patients had a postoperative persistent fever(2/11,18.2%),and 3 patients had postoperative pleural effusion in small amount(3/11,27.3%).Postoperative imaging data of patients in the scapular group revealed a satisfactory position of the scapular prosthesis and normal shoulder anatomy.During the follow-up after 1 year of surgery,the shoulder joint function of the three patients had reached the good evaluation criteria and had been able to independently complete most of the activities in life such as washing,dressing,eating,and opening and closing the door.Postoperative imaging data of patients in the clavicle group revealed that the clavicle prosthesis was in place,and the prosthesis and residual clavicle were internally fixed by plates and screws,without loosening.The anatomical relationship of the shoulder joint was normal with proper joint space and surrounding soft tissues.Functional recovery in patients of this group was the most significant and fastest of all patients.During functional assessment 1 month after surgery,the patient’s functional scores had reached more than 70 points,abduction could also reach 90°.The patients were able to independently complete most of the daily activities(except hair combing).In the third month after surgery,the shoulder function scores of the patients had reached more than 90 points,with excellent functional assessment results.The tibial group included the only attempt at the weight-bearing bone of the lower limb.Postoperative imaging data of the patient showed a localized absence of the upper end of the left tibia and artificial prosthesis placement.The image of internal fixation of steel rods and nails was observed in the middle and upper tibia,without clear signs of loosening and slippage.The patient was able to walk without a wheelchair 3 months after surgery on crutches.By the 6th month after surgery,the patient was able to squat,stand and perform other movements without aid and walk without crutches.One year after surgery,the patient was able to walk freely with no crutches.Postoperative images of patients in the fibula group revealed an absence of bone in the middle and lower fibula and artificial prosthesis placement,good alignment between the prosthesis and the residual fibula.Images of plate-screw internal fixator were detected,and no obvious signs of loosening,breakage,or displacement were detected in the unfixed parts.Ankle anatomy was normal and there were no signs of joint dislocation.The patient was able to walk slowly on crutches in the first month after surgery.The patient was already able to walk off wheelchairs and on a single crutch in the third month after surgery.Six months after surgery,the patient was able to walk freely without crutches,but with significant claudication when walking.One year after surgery,the patient was able to walk normally on flat ground,stairs,and steep slopes without crutches and without significant limp when walking.Postoperative imaging data of patients in the sternal group revealed an absence of manubrium sterni bone and artificial prosthesis placement,annular metal dense shadows in the manubrium sterni area,and no signs of prosthesis loosening,breakage,or displacement.Thereafter,each patient returned to the hospital for multiple imaging reexaminations,which revealed changes after prosthesis implantation,and there were no clear signs of loosening or breakage of the internal fixation.Conclusion:Precise tumor resection and perfect bone defect restoration can be achieved simultaneously in the following way:establish tumor model with assistance from computer,design surgical and subsequent restoration schemes based on security boundary principle of bone tumor resection,and then produce individualized surgical guide and custom-made PEEK prosthesis necessary to bone defect restoration by using 3D printing technology.3D PEEK prosthesis,light and can be produced within a short period of time,can be used for varying shapes of bone defect.Easy and precise to operate,prosthesis implantation shortens surgical duration and minimizes intraoperative blood loss and adverse events.The application of 3D printing technology to the production of PEEK prosthesis,necessary to restoration of bone defect caused by bone tumor resection,improves the restoration preciseness to a higher level.Preliminary clinical tests show it is safe,reliable and effective.Therefore,we can go a step further on clinical application of the new scheme. |
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