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

NCT07453329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-06

No results posted yet for this study

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

Conditions

  • Arthoplasty
  • Infected Hernioplasty Mesh
  • PJI

Interventions

PROCEDURE

the use of Custom-Made Articulating Spacer (CUMARS) in two-stage revision of infected hip joints.

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453329 on ClinicalTrials.gov