aap Implantate AG, Lorenzweg 5, 12099, Berlin, Germany.
Universitätsklinikum Regensburg, Klinik und Poliklinik für Unfallchirurgie, Franz-Josef-Strauß-Allee 111, 93042, Regensburg, Germany.
Trials. 2022 Dec 1;23(1):968. doi: 10.1186/s13063-022-06919-0.
Antimicrobial coatings of implants are of interest to reduce infection rate in orthopedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evaluate the clinical performance of a silver-coating for locking plates for fracture treatment.
The study design has to respect different criteria, such as feasibility, focus on overall complications, such as functional impairment, fracture healing, and particularly on infection rates. Distal tibia fractures were chosen due to the high prevalence of infections in this type of injuries, which warrants a particular benefit of antimicrobial prophylaxis and thus might allow to see a statistical trend in favor of the coated product. The study design was defined as a randomized, controlled, subject and observer-blinded, multi-center study in subjects with fractures of the distal tibia with a total of 226 patients. A number of 113 patients are planned for each of the two treatment arms with treatment of the fracture with a silver-coated device (first arm) or with an uncoated device (second arm). Inclusion criteria are closed fractures of the distal tibia according to the Tscherne-Oestern classification or open fractures of the distal tibia according to the Gustilo-Anderson classification in subjects older than 18 years. Primary outcome parameter is the Anticipated Adverse Device Effects (AADE) including all typical complications of this type of injury, such as functional impairment of the affected limb, non-union, and infections based on a non-inferiority study design. Also, silver-typical complications, such as argyria, are included. Secondary parameters are infection rates and fracture healing. Follow-up of patients includes five visits with clinical and X-ray evaluations with a follow-up time of 12 months.
Demonstration of clinical effectiveness of antimicrobial coatings of fracture fixation devices remains a challenge. Definition of a prospective randomized pre-market trial design and recruitment of clinical sites for such a study is possible. A confirmative proof of the expected clinical benefit in terms of reduction of device-related infections will be addressed with a prospective post-market clinical follow-up study in a second step due to the large sample size required.
ClinicalTrials.gov NCT05260463. Registered on 02 March 2022.
在骨科手术中，植入物的抗菌涂层可降低感染率，因此受到关注。然而，要获得市场批准，证明此类涂层植入物的临床疗效具有挑战性。本文旨在定义一项随机对照试验的设计，以评估一种用于骨折治疗的锁定板的银涂层的临床性能。
研究设计需要符合不同的标准，如可行性、关注整体并发症（如功能障碍、骨折愈合），特别是感染率。选择胫骨远端骨折是因为这种类型的损伤感染率很高，这需要特别的抗菌预防措施，因此可能会看到有利于涂层产品的统计趋势。该研究设计为一项随机、对照、患者和观察者双盲、多中心研究，共纳入 226 例胫骨远端骨折患者。计划每个治疗组各纳入 113 例患者，其中一组采用银涂层器械（第一组）治疗，另一组采用未涂层器械（第二组）治疗。纳入标准为 Tscherne-Oestern 分类的闭合性胫骨远端骨折或 Gustilo-Anderson 分类的开放性胫骨远端骨折，患者年龄大于 18 岁。主要结局参数是预期不良设备效应（AADE），包括该类型损伤的所有典型并发症，如受累肢体的功能障碍、骨不连和感染，研究设计为非劣效性研究。此外，还包括银相关并发症，如银沉着症。次要参数包括感染率和骨折愈合。患者随访包括 5 次临床和 X 射线评估，随访时间为 12 个月。
证明抗菌涂层骨折固定装置的临床疗效仍然具有挑战性。可以定义前瞻性随机上市前试验设计，并为该研究招募临床地点。由于需要大样本量，将在第二步进行前瞻性上市后临床随访研究，以验证降低器械相关感染的预期临床获益。
ClinicalTrials.gov NCT05260463。于 2022 年 3 月 2 日注册。
