CompletedNot Applicable

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

Egypt25 participantsStarted 2022-10-31

Plain-language 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

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age from 20-80 years old * Patients with PJI after hip arthroplasty according to MSIS criteria 2018 OR ICM 2018. * PJI \> 4 weeks post operative * Patients with chronic septic hip arthritis (either native or on top of infected proximal femur implant) Exclusion Criteria: * Age less than 20 years * Early postoperative PJI * Acute Hematogenous PJI * Fungal infection * Acute septic hip * gouty arthritis

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional outcomes of CUMARS during interstage period

Timeframe: both measured preoperative and 1 month -postoperative first stage for each patient

Functional outcomes of CUMARS during interstage period

Timeframe: both measured preoperative and 1 month -postoperative first stage for each patient

Trial details

NCT IDNCT07453329

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

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