Shah Nilen A, Shah Ronak V, Patel Vihalkumar D, Patel Deepak V
Bombay Hospital and Medical Research Centre, Mumbai 400020, Maharashtra, India.
Junior Consultant orthopaedic surgeon, Wockhardt Hospital Mira road, Mumbai 401107 Maharashtra.
J Long Term Eff Med Implants. 2025;35(1):31-44. doi: 10.1615/JLongTermEffMedImplants.2024046593.
Prosthetic bone and joint infections are difficult to treat with varying levels of success with standard therapy. Synthetic calcium sulfate carrier, to which specific antibiotics can be added, can be utilized as an alternative drug delivery system in these cases. We have reviewed clinical outcomes using commercially available pure synthetic calcium sulfate dissolvable beads (Stimulan) loaded with antibiotics in 143 patients undergoing orthopedic surgery for prevention and treatment of joint infection. Stimulan was added after standard surgical procedure in cases of: (1) Established infections, (2) Second stage of previously infected patients, or (3) High risk of infection. The purpose of this study was to (1) Evaluate the efficacy of Stimulan for eradicating the infection in patients with established infection, and (2) To study the efficacy of Stimulan for preventing infection in previously infected and healed, or high-risk group of patients. Established orthopedic surgical procedures (such as debridement, liner exchange, one-stage or two-stage revision surgery, or culture-specific systemic antibiotic therapy) were carried out to treat infection, and Stimulan was added in the medullary canal and soft tissue. In addition, postoperative infection and other complications were recorded. This prospective study data showed postoperative wound drainage in 4.9% and infection in 9.1% of total patients. Success rate after the use of Stimulan was 84.9% for established infected patients, 90.9% for previously infected patients, and about 97% for high-risk group patients. Based on the results of this study, we conclude that Stimulan is an acceptable novel drug delivery system for local antibiotic in septic or aseptic standard orthopedic surgeries. Moreover, postoperative infection rate was lower than any other antibiotic delivery system or drugs used before. Stimulan is also effective as a preventive measure for infection-prone patients.
人工骨和关节感染采用标准疗法治疗难度较大，治疗效果各异。可添加特定抗生素的合成硫酸钙载体，在这些情况下可作为一种替代药物递送系统。我们回顾了143例接受骨科手术以预防和治疗关节感染的患者使用载有抗生素的市售纯合成硫酸钙可溶珠（Stimulan）的临床结果。在以下情况下，于标准外科手术后添加Stimulan：（1）已确诊感染；（2）既往感染患者的第二阶段；或（3）感染高危患者。本研究的目的是：（1）评估Stimulan对根除已确诊感染患者感染的疗效；（2）研究Stimulan对预防既往感染且已愈合患者或高危患者感染的疗效。采用既定的骨科手术程序（如清创、衬垫更换、一期或二期翻修手术，或针对培养结果的全身抗生素治疗）治疗感染，并在髓腔和软组织中添加Stimulan。此外，记录术后感染及其他并发症。这项前瞻性研究数据显示，总患者中术后伤口引流率为4.9%，感染率为9.1%。对于已确诊感染的患者，使用Stimulan后的成功率为84.9%；对于既往感染患者，成功率为90.9%；对于高危组患者，成功率约为97%。基于本研究结果，我们得出结论：在感染性或无菌性标准骨科手术中，Stimulan是一种可接受的新型局部抗生素药物递送系统。此外，术后感染率低于之前使用的任何其他抗生素递送系统或药物。Stimulan作为易感染患者的预防措施也很有效。
