Clinical Trial

Assessment of Functional Outcomes of Custom-made Articulating Spacers in Two Stage Arthroplasty for Treatment of Infected Hip Joint

Completed
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Summary
The goal of this prospective observational study is to evaluate whether the use of a Custom-Made Articulating Spacer (CUMARS) can achieve satisfactory functional outcomes and effective infection control in patients undergoing two-stage revision for infected hip joints. The main questions it aims to answer are: Does the use of CUMARS provide acceptable functional outcomes during the interim period and after definitive reimplantation? Does CUMARS result in effective infection eradication with acceptable perioperative parameters and complication rates? Participants will: Undergo first-stage removal of the infected hip prosthesis and implantation of a Custom-Made Articulating Spacer Receive targeted systemic antibiotic therapy based on culture results Be followed up clinically and radiologically to assess function, complications, and infection status Undergo second-stage definitive hip reimplantation after confirmation of infection eradication
Trial Details
NCT Number NCT07453329
Lead Sponsor Ain Shams University
Conditions Arthoplasty, Infected Hernioplasty Mesh, PJI
Enrollment 25 participants
Start Date 2022-10-31
Primary Completion 2024-09-30 (estimated)
Study Completion 2024-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11