With high thermal stability, excellent mechanical properties, suitable biocompatibility and radiolucency, polyaryletherketones (PAEKs) have been widely used in biomedical field such as trauma, spinal implants, craniomaxillofacial repair and so on. However, PAEKs are bio-inert in nature and often show weak osteointegration with host bone, limiting their further utilization in biomedical application. Therefore, how to improve the bioactivity and osteointegration of PAEK implants has become the focus in biomedical field. This paper reviews the current research advance and some existed problems in bioactive PAEKs, and outlooks the possible solution.
ObjectiveTo study the effectiveness of tibial transverse transport combined with the antibiotics embedded bone cement in the treatment of chronic infection of foot and ankle with lower extremity ischemic diseases.MethodsA retrospective analysis was performed on 28 patients with ischemic diseases of lower extremities associated with chronic foot and ankle infection who were treated with tibial transverse transport combined with antibiotic bone cement between August 2015 and October 2019. There were 22 males and 6 females, with an average age of 65.6 years (range, 41-86 years). There were 25 cases of diabetic foot, 2 cases of arteriosclerosis obliterans, and 1 case of thromboangiitis obliterans. The course of infection ranged from 1 to 27 years, with an average of 14.9 years. The healing condition and time of foot and ankle in all patients were recorded and compared, and the Wagner grading and WIFi (W: lower extremity wound classification; I: ischemic classification; Fi: foot infection classification) grading were compared before and at last follow-up.ResultsThe wound surface of 1 diabetic foot patient improved at 111 days after operation, without purulent secretion, and lost follow-up. The remaining 27 cases were followed up 5 to 21 months (mean, 8.4 months). There was no necrosis in the tibial osteotomy incision and the local flap. After operation, 21 cases showed needle reaction of external fixator, but the needle infection gradually improved after the corresponding treatment. Among the 24 patients with diabetic foot, 1 died of multiple organ failure due to pulmonary infection. Acute lower extremity vascular embolism occurred in 1 case, and the foot was amputated due to acute gangrene. In the remaining 22 cases, the wound healing time of foot and ankle was 2.5-11.0 months (mean, 4.6 months). At last follow-up, Wagner grading and WIFi grading of the patients were significantly improved when compared with those before operation (P<0.05). One patient with thromboangiitis obliterans had foot and ankle healing at 6 months after operation. Two patients with lower extremity arteriosclerosis obliterans had foot and ankle healing at 16 and 18 months after operation, respectively.ConclusionTibial transverse transport combined with the antibiotics embedded bone cement is effective in treating chronic infection of foot and ankle with lower extremity ischemic diseases.
Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidence-based scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and cost-effectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.