SBIR Phase I: Antibiotic Dispensing Spacer for improved treatment of PJI in TKA

该SBIR I期项目将有助于解决全膝关节置换关节感染患者的迫切需求。 不幸的是，医生们几乎没有什么好的选择来有效地治疗这种类型的感染，以避免截肢的可能性，甚至死亡，如果感染持续和蔓延。 今天，治疗需要手术替换部分或全部现有的植入物，同时使用口服或静脉注射抗生素。 由于关节周围的胶囊（与血管隔离），这些方法在细菌驻留的膝盖内提供了少量的抗生素。 患者需要接受长时间的治疗，很多时候不使用膝盖，等待细菌感染慢慢消退。 ForCast骨科的抗生素分配膝关节间隔器在人工膝关节内提供了一个可再填充的储存器，可以将抗生素直接分配到膝关节囊中，以进行有效的感染治疗。 医生可以为诊断出的细菌开出最合适的抗生素。 患者每周返回医生办公室进行一次检查和抗生素补充注射，直到感染治愈。 不需要后续手术。重复先前成功的临床研究的抗生素递送（使用代表性但不可耐受的每日注射）应导致类似的高度成功的患者结局，减少患者痛苦和降低医疗成本。 今天，医生几乎没有好的治疗选择，以避免截肢的可能性，甚至死亡，如果PJI持续和蔓延。 所有方法都需要手术清创和更换部分或全部现有植入物（以减少细菌负荷），同时使用口服或静脉注射抗生素，这些抗生素无法到达膝关节囊内的剩余细菌（血液/滑液屏障）。临时洗脱抗生素间隔物和珠的寿命太短。患者遭受延长治疗，许多时候没有承重膝关节。 ForCast Orthopedics正在开发一种抗生素分配垫片（AD垫片），以取代全膝关节植入物中的标准垫片。 AD间隔器提供了一个可再填充的储液器，用于容纳所识别细菌的抗生素选择，并提供了一个输送系统，用于在整个治疗期间（通常至少6周）保持膝关节内的治疗浓度。作为永久性间隔器，治疗后无需进一步手术。 模仿以前成功的临床研究（使用不可耐受的每日注射）的交付特性应导致类似的高度成功的患者结果，降低发病率和降低总成本的护理。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

This SBIR Phase I project will help to address a critical need for patients who have suffered an infection in a total knee replacement joint. Unfortunately, doctors have few good options for effectively treating this type of infection to avoid the potential for limb amputation or even death should the infection persist and spread. Today, treatment requires surgical replacement of part or all of the existing implant while using oral or intravenous antibiotics. Due to the capsule around the joint (isolated from blood vessels) these methods deliver marginal amounts of antibiotic within the knee where the bacteria reside. Patients suffer elongated treatment, many times without the use of their knee, waiting for the bacterial infection to slowly resolve. ForCast Orthopedics' Antibiotic Dispensing Knee Spacer provides a refillable reservoir within the artificial knee that can distribute antibiotic directly into the knee capsule for effective infection treatment. Physicians can prescribe the antibiotic most appropriate for the bacteria diagnosed. The patient returns to the doctor's office once per week for a checkup and antibiotic refill injection until the infection is cured. No follow up surgery is required. Duplicating the antibiotic delivery of previous successful clinical studies (using representative but intolerable daily injections) should result in similar highly successful patient outcomes, reduced patient suffering and reduced healthcare costs.This SBIR Phase I project addresses an underserved clinical need for improved treatment of Periprosthetic Joint Infection (PJI). Today, doctors have few good options for treatment to avoid the potential for limb amputation or even death should PJI persist and spread. All methods require surgical debridement and replacement of part or all of the existing implant (to reduce bacterial load) while using oral or intravenous antibiotics that cannot reach the remaining bacteria within the knee capsule (blood/synovial fluid barrier). Temporary eluting antibiotic spacers and beads are too short lived. Patients suffer elongated treatment, many times without a load-bearing knee. ForCast Orthopedics is developing an Antibiotic Dispensing Spacer (AD Spacer) to replace the standard spacer in a total knee implant. The AD Spacer provides a refillable reservoir to hold the antibiotic of choice for the bacteria identified and a delivery system to maintain a therapeutic concentration within the knee for the entire therapy duration, typically a minimum of 6 weeks. As a permanent spacer, no further surgery is required after treatment. Emulating the delivery characteristics of previously successful clinical studies (using intolerable daily injections) should result in similar highly successful patient outcomes, reduced morbidity and reduced total cost of care.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.