The evaluation of blood compatibility of biomaterials is crucial for ensuring the clinical safety of implantable medical devices. To address the limitations of traditional testing methods in real-time monitoring and electrical property analysis, this study developed a portable electrical impedance tomography (EIT) system. The system uses a 16-electrode design, operates within a frequency range of 1 to 500 kHz, achieves a signal to noise ratio (SNR) of 69.54 dB at 50 kHz, and has a data collection speed of 20 frames per second. Experimental results show that the EIT system developed in this study is highly consistent with a microplate reader ( R ²=0.97) in detecting the hemolytic behavior of industrial-grade titanium (TA3) and titanium alloy-titanium 6 aluminum 4 vanadium (TC4) in anticoagulated bovine blood. Additionally, with the support of a multimodal image fusion Gauss-Newton one-step iterative algorithm, the system can accurately locate and monitor in real-time the dynamic changes in blood permeation and coagulation caused by TC4 in vivo. In conclusion, the EIT system developed in this study provides a new and effective method for evaluating the blood compatibility of biomaterials.
Electric Impedance ; Animals ; Tomography/instrumentation* ; Biocompatible Materials ; Materials Testing/instrumentation* ; Cattle ; Titanium ; Alloys ; Prostheses and Implants

This review article summarizes the current modification methods employed to enhance the osseointegration properties of polyetheretherketone (PEEK), a novel biomaterial. Our analysis highlights that strategies such as surface treatment, surface modification, and the incorporation of bioactive composites can markedly improve the bioactivity of PEEK surfaces, thus facilitating their effective integration with bone tissue. However, to ensure widespread application of PEEK in the medical field, particularly in oral implantology, additional experiments and long-term clinical evaluations are required. Looking ahead, future research should concentrate on developing innovative modification techniques and assessment methodologies to further optimize the performance of PEEK implant materials. The ultimate goal is to provide the clinical setting with even more reliable solutions.
Benzophenones ; Ketones/chemistry* ; Polyethylene Glycols/chemistry* ; Osseointegration ; Humans ; Polymers ; Biocompatible Materials/chemistry* ; Surface Properties ; Prostheses and Implants ; Dental Implants

OBJECTIVE: To analyze the effectiveness of single three-dimensional (3D)-printed microporous titanium prostheses and flap combined prostheses implantation in the treatment of large segmental infectious bone defects in limbs. METHODS: A retrospective analysis was conducted on the clinical data of 76 patients with large segmental infectious bone defects in limbs who were treated between January 2019 and February 2024 and met the selection criteria. Among them, 51 were male and 25 were female, with an age of (47.7±9.4) years. Of the 76 patients, 51 had no soft tissue defects (single prostheses group), while 25 had associated soft tissue defects (flap combined group). The single prostheses group included 28 cases of tibial bone defects, 11 cases of femoral defects, 5 cases of humeral defects, 4 cases of radial bone defects, and 3 cases of metacarpal, or carpal bone defects, with bone defect length ranging from 3.5 to 28.0 cm. The flap combined group included 3 cases of extensive dorsum of foot soft tissue defects combined with large segmental metatarsal bone defects, 19 cases of lower leg soft tissue defects combined with large segmental tibial bone defects, and 3 cases of hand and forearm soft tissue defects combined with metacarpal, carpal, or radial bone defects, with bone defect length ranging from 3.8 to 32.0 cm and soft tissue defect areas ranging from 8 cm×5 cm to 33 cm×10 cm. In the first stage, vancomycin-loaded bone cement was used to control infection, and flap repair was performed in the flap combined group. In the second stage, 3D-printed microporous titanium prostheses were implanted. Postoperative assessments were performed to evaluate infection control and bone integration, and pain release was evaluated using the visual analogue scale (VAS) score. RESULTS: All patients were followed up postoperatively, with an average follow-up time of (35.2±13.4) months. In the 61 lower limb injury patients, the time of standing, walk with crutches, and fully bear weight were (2.2±0.6), (3.9±1.1), and (5.4±1.1) months, respectively. The VAS score at 1 year postoperatively was significantly lower than preoperative one ( t=-10.678, P<0.001). At 1 year postoperatively, 69 patients (90.8%) showed no complication such as infection, fracture, prosthesis displacement, or breakage, and X-ray films indicated good integration at the prosthesis-bone interface. According to the Paley scoring system for the healing of infectious bone defects, the results were excellent in 37 cases, good in 29 cases, fair in 3 cases, and poor in 7 cases. In the single prostheses group, during the follow-up, there was 1 case each of femoral prostheses fracture, femoral infection, and tibial infection, with a treatment success rate of 94.1% (48/51). In lower limb injury patients, the time of fully bear weight was (5.0±1.0) months. In the flap combined group, during the follow-up, 1 case of tibial fixation prostheses screw fracture occurred, along with 2 cases of recurrent foot infection in diabetic patients and 1 case of tibial infection. The treatment success rate was 84.0% (21/25). The time of fully bear weight in lower limb injury patients was (5.8±1.2) months. The overall infection eradication rate for all patients was 93.4% (71/76). CONCLUSION The use of 3D-printed microporous titanium prostheses, either alone or in combination with flaps, for the treatment of large segmental infectious bone defects in the limbs results in good effectiveness with a low incidence of complications. It is a feasible strategy for the reconstruction of infectious bone defects.
Humans ; Male ; Female ; Middle Aged ; Printing, Three-Dimensional ; Titanium ; Retrospective Studies ; Surgical Flaps ; Adult ; Prosthesis Implantation/methods* ; Plastic Surgery Procedures/methods* ; Treatment Outcome ; Prostheses and Implants ; Bone Diseases, Infectious/surgery* ; Extremities/surgery* ; Prosthesis Design

OBJECTIVE: To investigate the effectiveness of three-dimensional (3D) printed customized hemi-pelvic prosthesis for pelvic reconstruction after resection of massive pelvic tumors. METHODS: A retrospective analysis was conducted on 26 patients with massive pelvic tumors who met the selection criteria and were treated between November 2021 and May 2024. The cohort included 11 males and 15 females, with a mean age of 52.65 years (range, 17-73 years). Histopathological diagnoses were as follows: 9 cases of chondrosarcoma, 2 of undifferentiated pleomorphic sarcoma, 4 of spindle cell sarcoma, 2 of osteosarcoma, 1 of solitary fibrous tumor, 1 of myxoid chondroma, 1 of malignant peripheral nerve sheath tumor, 1 of chondromyxoid epithelioma, and 5 of metastatic malignant tumors. According to the Enneking classification, tumor involvement was distributed as 4 cases in zones Ⅰ+Ⅱ, 9 in zones Ⅱ+Ⅲ, 3 in zones Ⅰ+Ⅳ, 8 in zones Ⅰ+Ⅱ+Ⅲ, and 2 in zones Ⅰ+Ⅱ+Ⅳ. The disease duration ranged from 3 to 40 months, with a mean of 9.85 months. All patients underwent reconstruction with customized 3D-printed hemi-pelvic prostheses. The effectiveness was evaluated by Musculoskeletal Tumor Society (MSTS) score and Harris hip score before operation and at last follow-up, and pain levels were evaluated by visual analogue scale (VAS) score before operation, at 3 months after operation, and at last follow-up. RESULTS: The operation time ranged from 186 to 528 minutes, with a mean of 334.58 minutes. The intraoperative blood loss ranged from 1 400 to 4 000 mL, with a mean of 2173.08 mL, and the transfusion volume ranged from 750 to 3 500 mL, with a mean of 1 659.62 mL. All 26 patients were followed up 10-42 months (mean, 18.5 months). Postoperative complications included prosthetic dislocation in 2 cases, which were attributed to improper positioning during home care and an accidental fall, respectively. One patient developed a vesicocutaneous fistula and poor wound healing due to pre-existing tumor invasion into the bladder. One patient experienced failure and loosening of the internal fixation at 8 months after operation caused by local tumor recurrence, and subsequently died at 14 months postoperatively due to progression of brain metastases. Postoperative complications such as poor healing of incisions, prosthetic dislocation, or failure of internal fixation was not observed in the remaining patients. At last follow-up, the walking ability of most patients recovered to varying degrees. The VAS scores at 3 months and at last follow-up significantly improved when compared with those before operation, and the scores at last follow-up further improved when compared with 3 months after operation, all showing significant differences ( P<0.05). The MSTS scores and Harris scores at last follow-up were significantly higher than those before operation ( P<0.05). CONCLUSION 3D printed customized hemi-pelvic prosthesis is effective for reconstruction of massive pelvic tumors after resection, but there are still some limitations, and soft tissue reconstruction should be paid attention to.
Humans ; Printing, Three-Dimensional ; Female ; Male ; Adult ; Plastic Surgery Procedures/methods* ; Retrospective Studies ; Middle Aged ; Aged ; Pelvic Bones/surgery* ; Bone Neoplasms/surgery* ; Adolescent ; Pelvic Neoplasms/surgery* ; Prosthesis Design ; Young Adult ; Treatment Outcome ; Prostheses and Implants

Cleaning process validation is an important guarantee for implantable medical devices to ensure product cleanliness. In the manufacturing process, implantable devices usually need to control pollution through cleaning process to achieve a certain cleanliness to ensure the effectiveness of sterilization and product safety. This paper discusses the cleaning process validation of the manufacturing process of the implantable devices based on relevant regulations and technical standards, and proposes the influencing factors and principles to be considered in the cleaning process validation, so as to provide technical reference for the design of the cleaning process validation.
Prostheses and Implants ; Sterilization ; Equipment and Supplies

Due to their good properties of elastic modulus, degradability and ability to promote bone repair, magnesium alloys have become a research hotspot in research of orthopedic implants. Nevertheless, most of the biomedical magnesium alloys currently available fail to meet the requirements in orthopedics because of their rapid degradation after implantation. Rare earth-magnesium alloys possess excellent corrosion resistance and are expected to become important materials as clinical orthopedic implants. This review summarizes the recent progress in studies of the physiological functions of rare earth elements, the effects of supplementation of rare earth elements on biomechanical properties and the in vitro and in vivo biocompatibility of magnesium alloys, and their contribution to tendon-bone healing, addressing also the current clinical orthopedic applications of different rare earth-magnesium alloys, challenges, and future strategies for improving these alloys.
Alloys/chemistry* ; Magnesium/chemistry* ; Metals, Rare Earth/chemistry* ; Humans ; Biocompatible Materials ; Prostheses and Implants

Van Nes rotationplasty has gained popularity as a surgical treatment for malignant bone tumors without resorting to amputation. However, the nature of the surgery poses unique challenges in the rehabilitation management in order to optimize safety and functional mobility. We describe a case of a 6-year-old female with Ewing’s sarcoma of the right femur who underwent Van Nes Type BIIIA rotationplasty. This procedure involved a complete femoral resection, with the tibia and the foot rotated by 180 degrees and the lateral tibial plateau placed into the acetabulum that is expected to remodel to form a neo-hip joint. The patient was referred to rehabilitation medicine and was eventually admitted due to impairment in mobility secondary to the surgery. The goal was to achieve K-1 level of function. This case demonstrates that the rehabilitation management of a child with Type B-IIIA rotationplasty using a modified Van Nes prosthesis requires a comprehensive multidisciplinary approach.

Female ; Humans ; Consensus ; East Asian People ; Pelvic Floor/surgery* ; Prostheses and Implants ; Registries ; Plastic Surgery Procedures/adverse effects* ; Prosthesis Implantation

OBJECTIVE: To investigate the long-term effectiveness of uncemented allograft-prosthesis composite (APC) for reconstruction of bone defects after proximal femur tumor resection. METHODS: Between June 2007 and March 2014, 21 patients who underwent uncemented APC reconstruction of proximal femur after tumor resection were retrospectively evaluated. There were 9 males and 12 females with an average age of 33.2 years (range, 19-54 years). There were 9 cases of giant cell tumor of bone, 5 cases of osteosarcoma, 4 cases of osteoblastic osteosarcoma, 2 cases of chondrosarcoma, and 1 case of undifferentiated pleomorphic sarcoma. Thirteen cases of benign bone tumors were all classified as stage 3 by Enneking staging; and 8 cases of malignant bone tumors were classified as grade ⅡB in 7 cases and grade ⅡA in 1 case according to the American Joint Committee on Cancer (AJCC) staging system. Among them, 7 patients underwent reoperation after recurrence, and the rest were primary operations; 8 patients presented with pathological fractures. The preoperative Harris hip score (HHS) and American Musculoskeletal Tumor Society (MSTS) score was 40 (30, 49) and 9.1±3.5, respectively. The length of osteotomy was 80-154 mm, with an average of 110 mm. At 1 year after operation and last follow-up, HHS and MSTS scores were utilized to evaluate the function of hip joint; the gluteus medius strength score was used to evaluation of the hip abduction function. Image examinations were taken at 1, 3, 6, 9, and 12 months after operation and every year thereafter to assess the union of allograft-host bone interfaces. Intra- and post-operative complications were also recorded. RESULTS: All patients were followed up 84-163 months (mean, 123.5 months). At 1 year after operation and last follow-up, the HHS and MSTS scores significantly improved when compared with the preoperative scores ( P<0.05). However, there was no significant difference in the HHS score, MSTS score, and gluteus medius strength score between the two time points after operation ( P>0.05). Image examination showed that all allograft-host bone interfaces achieved union after 5-10 months (mean, 7.6 months). At last follow-up, all patients had bone resorption, including 11 severe cases, 4 moderate cases, and 6 mild cases; the bone resorption sites included Gruen 1, 2, and 7 regions. Complications included 10 fractures and 1 prosthetic fracture. Local recurrence occurred in 3 patients and pulmonary metastasis in 3 patients. CONCLUSION Uncemented APC is a reliable method for the reconstruction of bone defects after proximal femur tumor resection. It has the good long-term effectiveness and possesses obvious advantages in the union at the bone-bone surface.
Adult ; Female ; Humans ; Male ; Allografts/pathology* ; Bone Neoplasms/surgery* ; Bone Resorption/pathology* ; Bone Transplantation/methods* ; Femur/surgery* ; Osteosarcoma/pathology* ; Prostheses and Implants ; Retrospective Studies ; Treatment Outcome ; Young Adult ; Middle Aged

OBJECTIVE: To review antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants, so as to provide reference for subsequent research. METHODS: The related research literature on antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants in recent years was reviewed, and the research progress was summarized based on different kinds of antibacterial substances and osteogenic active substances. RESULTS: At present, the antibacterial/osteogenesis dual-functional surface modification strategy of titanium-based implants includes: ① Combined coating strategy of antibiotics and osteogenic active substances. It is characterized in that antibiotics can be directly released around titanium-based implants, which can improve the bioavailability of drugs and reduce systemic toxicity. ② Combined coating strategy of antimicrobial peptides and osteogenic active substances. The antibacterial peptides have a wide antibacterial spectrum, and bacteria are not easy to produce drug resistance to them. ③ Combined coating strategy of inorganic antibacterial agent and osteogenic active substances. Metal ions or metal nanoparticles antibacterial agents have broad-spectrum antibacterial properties and various antibacterial mechanisms, but their high-dose application usually has cytotoxicity, so they are often combined with substances that osteogenic activity to reduce or eliminate cytotoxicity. In addition, inorganic coatings such as silicon nitride, calcium silicate, and graphene also have good antibacterial and osteogenic properties. ④ Combined coating strategy of metal organic frameworks/osteogenic active substances. The high specific surface area and porosity of metal organic frameworks can effectively package and transport antibacterial substances and bioactive molecules. ⑤ Combined coating strategy of organic substances/osteogenic active substancecs. Quaternary ammonium compounds, polyethylene glycol, N-haloamine, and other organic compounds have good antibacterial properties, and are often combined with hydroxyapatite and other substances that osteogenic activity. CONCLUSION The factors that affect the antibacterial and osteogenesis properties of titanium-based implants mainly include the structure and types of antibacterial substances, the structure and types of osteogenesis substances, and the coating process. At present, there is a lack of clinical verification of various strategies for antibacterial/osteogenesis dual-functional surface modification of titanium-based implants. The optimal combination, ratio, dose-effect mechanism, and corresponding coating preparation process of antibacterial substances and bone-active substances are needed to be constantly studied and improved.
Anti-Bacterial Agents/pharmacology* ; Coated Materials, Biocompatible/chemistry* ; Metal-Organic Frameworks/pharmacology* ; Osteogenesis ; Surface Properties ; Titanium/pharmacology* ; Prostheses and Implants