HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip joint infections.

backgroundPeriprosthetic joint infection (PJI) is one of the most severe complications in hip arthroplasty, and treatment of PJI is associated with high re-infection rates and significant loss of quality of life for patients, as well as socio-economic impact to health systems. Antimicrobial coating of implants with silver is a promising option to improve the outcome of PJI. However, there is no data from randomized control trials on silver-coated versus standard non-silver-coated implants in patients with PJI. Therefore, the aim of the current study is to assess clinical outcome for the use of silver-coated hip implants (further referred to as IP-coated) versus non-IP-coated implants in patients requiring surgical revision for hip PJI.

methodsThis is a multicenter confirmatory interventional randomized controlled superiority single-blinded study with two stages: pilot stage (part A) and pivotal stage (part B). Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection planned for single-stage or two-stage surgical procedures are included. Patients will randomly be assigned either to the IP-coated or the non-IP-coated implant group. The primary outcome parameter is infection-free survival within 12 months after hip PJI. The underlying hypothesis is that the IP coating significantly reduces the risk of periprosthetic reinfection compared to the non-IP-coated implants. Secondary outcome parameters include data on the safety and performance of the prostheses through a 2-year clinical follow-up, including patient-related outcome parameters, such as Harris Hip Score, EQ-5D, radiographical assessment, and blood silver concentrations. An adaptive study design is planned with the inclusion of 268 subjects according to initial sample size calculations. Upon follow-up of 134 patients for 12 months or inclusion of 90% of the study patients, preliminary study results will be used to re-estimate the sample size, which may be extended up to 400 subjects. DISCUSSION: The current study aims to fill the evidence gap for the idea of IP-coated implants to reduce re-infection rates in the treatment of hip PJI. To the authors' best knowledge, this is the first randomized controlled superiority trial evaluating the outcome of a silver-coated versus a non-silver-coated prosthesis for the treatment of hip PJI. The adaptive study design allows an adjustment of the initial sample size to reduce the risk of an underpowered superiority.

trial registrationClinicalTrials.gov NCT06737809 (date of publication 17.12.2024).